Systematic Review of Salutogenic-Oriented Lifestyle Randomised Controlled Trials For Adults With Type 2 Diabetes Mellitus

Patient Education and Counseling 103 (2020) 764–776
Contents lists available at ScienceDirect
Patient Education and Counseling

journal homepage: www.elsevier.com/locate/pateducou
Review Article
Systematic review of salutogenic-oriented lifestyle randomised

controlled trials for adults with type 2 diabetes mellitus
C.M.M. Polhuis (Kristel)a,* , L.I. Bouwman (Laura)a , L. Vaandrager (Lenneke)a ,
S.S. Soedamah-Muthu (Sabita)b,c, M.A. Koelen (Maria)a
a
Health and Society, Wageningen University, Wageningen, The Netherlands
b
Center of Research on Psychological and Somatic disorders (CORPS), Department of Medical and Clinical Psychology, Tilburg University, Tilburg,
The Netherlands
c
Institute for Food, Nutrition and Health, University of Reading, Reading, United Kingdom
A R T I C L E I N F O A B S T R A C T
Article history: Objective: Describe the characteristics (development, intensity, deliverers, setting, strategies) and assess
Received 12 November 2018 the effect of salutogenic-oriented lifestyle interventions on physical and psychosocial health outcomes in
Received in revised form 18 October 2019 adults with type 2 diabetes mellitus (T2DM).
Accepted 19 October 2019
Method: PubMed, Scopus and PsycINFO were systematically searched for randomised controlled trials
(RCTs) published up to August 2019 that complied with predefined salutogenic criteria: the participant as
Keywords: a whole, the participant’s active involvement and the participant’s individual learning process.
Type 2 diabetes mellitus
Characteristics of the salutogenic-oriented interventions with and without significant results were
Salutogenesis
Lifestyle interventions
compared and qualitatively summarised.
Physical health Results: Twenty-eight RCTs were identified. Salutogenic oriented interventions that significantly improved
Psychosocial health both physical and psychosocial health were characterized by being based on formative research, culturally
Patient-centred targeted, and delivered in 10–20 sessions in group settings, whereas salutogenic oriented interventions that
neither improved physical or psychosocial health significantly were characterized by being individually
tailored and delivered in less than 10 group sessions in individual settings.
Conclusions: This systematic review suggests that salutogenic-oriented lifestyle interventions are effective
for physical and psychosocial health in the short term. More research is needed to determine how
intervention characteristics moderate (long-term) effectiveness.
Practice implications: The results provide a basis for purposefully developing effective salutogenic
interventions for adults with T2DM.
© 2019 Elsevier B.V. All rights reserved.
Contents
1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 765
1.1. Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 765
1.1.1. The participant as a whole . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 765
1.1.2. The participant’s active involvement . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 765
1.1.3. The participant’s individual learning process . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766
1.2. Aim . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766
2. Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766
2.1. Search strategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766
2.2. Study selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766
2.2.1. From salutogenic principles to inclusion criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766
2.2.2. Inclusion and exclusion criteria . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766
Abbreviations: T2DM, type 2 diabetes mellitus; RCT, randomised controlled trial; SMBG, self-monitoring blood glucose; HbA1c, glycosylated haemoglobin; BMI, body mass
index; QoL, quality of life; SOI, salutogenic-oriented intervention; CHW, community health worker.
* Corresponding author at: Health and Society, Wageningen University, Wageningen, P.O. Box 8130, 6700 EW, The Netherlands.
E-mail address: [email protected] (C.M.M. Polhuis).
https://doi.org/10.1016/j.pec.2019.10.017
0738-3991/© 2019 Elsevier B.V. All rights reserved.
C.M.M. Polhuis et al. / Patient Education and Counseling 103 (2020) 764–776 765
2.3. Quality assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766

2.4. Data extraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766
2.5. Data synthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766
3. Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 767
3.1. Description of the search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 767
3.2. General characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 768
3.2.1. Study population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 768
3.2.2. Intervention characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 769
3.3. Realisation of the salutogenic principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 769
3.3.1. The participant as a whole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 769
3.3.2. The participant’s active involvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 769
3.3.3. The participant’s individual learning process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 769
3.4. Data synthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 771
3.4.1. Effect sizes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 771
3.4.2. Comparison of effective and non-effective SOIs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 772
4. Discussion and conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 773
4.1. Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 773
4.1.1. The participant as a whole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 773
4.1.2. The participant’s active involvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 773
4.1.3. The participant’s individual learning process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 773
4.2. Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 774
4.3. Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 774
4.4. Practical implications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 774
Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 774
Author contributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 774
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 774
1. Introduction Salutogenesis complements current biomedical approaches by

adding three principles that may be important for successfully
1.1. Background implementing and sustaining healthy behaviours in daily life; the
participant as a whole, active involvement and learning.
Lifestyle interventions can improve insulin sensitivity and
glycaemic control in adults with type 2 diabetes mellitus (T2DM) 1.1.1. The participant as a whole
[1–4]. In some cases, medication can even be stopped if fasting It is often assumed that health is the absence of (physical) disease
glucose levels normalise to <7 mmol/L [1,3,4]. Yet, sustaining these [29–31]; however, in salutogenesis, health is a complex concept
health effects in everyday life appears to be difficult to achieve incorporating multiple aspects of wellbeing that relate to the whole
employing current lifestyle interventions [5–8]. Standard lifestyle person [32,33]. According to Antonovsky, researchers should focus
interventions are biomedically oriented and therefore driven by on human beings with T2DM, instead of focusing solely on the
a risk-oriented approach focused on the examination and disease and its physical health consequences [33]. This necessitates
elimination of general risk factors leading to T2DM, achieved the suggestion of T2DM lifestyle interventions that aim to improve
using medication to regulate blood glucose levels and control multiple aspects of health and wellbeing, including the physical,
cardiovascular disease risk control [9]. Most lifestyle interventions mental, social, and spiritual dimensions. For example, depression is
are still narrowly focused on glycosylated haemoglobin (HbA1c) common among people with T2DM [34], which can obstruct
and other biomedical health parameters [7,10]. Avoiding physical the improvement of health using lifestyle interventions [35].
disease is the central goal, while the mental, social and spiritual Alternative interventions targeting multiple dimensions of health
dimensions of health are often ignored. Such de-contextualizing may therefore be more effective for these people.
interventions ignore the fact that human beings are complicated
creatures with complex inner and outer worlds that largely 1.1.2. The participant’s active involvement
influence why, what, and how we do things in life [11,12]. Understanding the unique life story and current life situation of
Consequently, de-contextualisation makes it difficult to adhere to adults with T2DM is important for providing meaningful care;
T2DM lifestyle guidelines in everyday life. The fact that increasing however, these are often not taken into account in current
numbers of people with T2DM follow (unproven) complementary interventions [36]. Langeland and Vinje [37] explain the impor-
and/or alternative medicine can be seen as a negative side effect of tance of these factors as follows: ‘Only in awareness of one’s life
de-contextualisation [13]. situation can the resources that contribute to recovery be found,
Increasingly, researchers advocate a holistic, patient-centred understood and fostered’ (p. 300). Indeed, adults with T2DM express
approach that is respectful of and responsive to the individual a need for more tailored support to self-manage T2DM, which
preferences, needs, and values of adults with T2DM [14–20]; should be meaningful to their everyday life [38,39]. Adjusting
however, confusion exists about what patient-centredness entails, lifestyle intervention strategies to the individual’s priorities,
how it should be accomplished, and how it should be measured motivations and capabilities increases the chance of accomplishing
[21]. Patient-centredness is still a rather abstract concept, and clear meaningful and active participation in the interventions [40] and
guidance for translating this concept into effective interventions is the successful implementation of newly adopted behaviours in
lacking, making it difficult to develop and implement innovative, everyday life. This can only be done successfully and respectfully
patient-centred interventions. when adults with T2DM are actively involved in the development
\It has been suggested that salutogenesis, a theoretical frame- and determination of their intervention strategies; for example,
work devised by Antonovsky [22], may be useful for guiding patient- focus groups involving adults with T2DM can be used to determine
centred lifestyle interventions for adults with T2DM [23–28]. the preferred intervention content.
766 C.M.M. Polhuis et al. / Patient Education and Counseling 103 (2020) 764–776
1.1.3. The participant’s individual learning process the search, selection and quality assessment processes were
Salutogenesis complements traditional information-providing completed by CMMP.
approaches by supporting individuals in a learning process to
develop self-identity. Antonovsky regarded self-identity as a 2.2. Study selection
crucial resource for coping as the image one has of oneself
influences one’s relationship with the world ([22]; 109–110). A 2.2.1. From salutogenic principles to inclusion criteria
learning process focussed on self-identify may lead to the Only RCTs that incorporated the three salutogenic principles (to
discovery of individual internal and external resources that can a certain extent) were included. Table 1 provides an overview of
be used to facilitate coping with T2DM-specific challenges, how the theoretical salutogenic principles were translated into
including the physiological defects, psychological consequences inclusion criteria. These specific salutogenic inclusion criteria were
and implementation of structural changes in daily routines. determined based on the consultation of several literature sources
Incorporating sessions dedicated to self-examination and coping (including [32,33,44,45]) and several discussions between the
in T2DM lifestyle interventions, such as through the use of authors.
narrative therapy (i.e., listening to the participant’s experience and
narrative identity in an open, accepting manner), may strengthen 2.2.2. Inclusion and exclusion criteria
self-identity [41]. Besides the three salutogenic criteria, studies were also selected
based on criteria regarding the publication type, study design,
1.2. Aim population, control, development, strategy and outcomes (Table 2).
The aim of this review is to describe the characteristics and 2.3. Quality assessment
assess the effectiveness of randomised controlled trials (RCTs)
comparing salutogenic-oriented lifestyle interventions (SOIs) with Quality was assessed using a quality assessment tool for
the usual care of adults with T2DM. The systematic literature quantitative studies (EPHPP) [46]. Nine studies were assessed as
search is based on inclusion criteria derived from the described “strong”, 11 as “moderate”, and eight as “weak” (supplementary
salutogenic principles. The literature was not searched for RCTs materials, Table B.1). Studies were not excluded based on quality,
based directly on salutogenesis because only one such study could but the quality of the evidence was taken into account in the data
be identified [42]. The results are used to more clearly define the synthesis.
(moderators of) effective patient-centred T2DM lifestyle
interventions that could be used to develop salutogenic T2DM 2.4. Data extraction
lifestyle interventions. To our knowledge, this is the first review
translating salutogenic principles into selection criteria and Information extracted on the study characteristics described in
applying them systematically to the current T2DM evidence base. Table 3 .
2. Methods 2.5. Data synthesis
2.1. Search strategy The research aim, search string and selection criteria were
decided upon a priori. The initial plan to perform a meta-analysis
The systematic review was performed in accordance with the was not possible due to the substantial differences observed in the
Preferred Reporting Items for Systematic Reviews and Meta- definitions of variables, measurement methods, time of outcome
Analyses [43]. The search strategies were based on the following assessment, intervention contents and contexts; therefore,
key concepts and their corresponding synonyms: 1) type 2 the present data synthesis was decided upon a posteriori. The
diabetes mellitus, 2) lifestyle, 3) randomised controlled trial, 4) data synthesis used was inspired by R.E. Slavin’s ideas on Best-
psychosocial health and 5) physiological health. As an example, the Evidence Synthesis [47].
exact PubMed search strategy is provided in the supplementary First, the study population, general intervention characteristics,
materials (Table A.1). The literature search was continuously and realisation of the three salutogenic principles among the SOIs
updated until 16th August 2019. Reference lists from relevant were described. Second, physical and psychosocial health outcomes
articles and reviews were manually searched for potentially were displayed (significant when p < 0.05) and the effectiveness of
relevant citations not detected by the electronic searches. All the SOIs with a moderate to strong quality (n = 20) was assessed by
authors were involved in the development of the salutogenic calculating the effect sizes for each physical and psychosocial health
criteria and search strategy, and were continuously consulted outcome. An overall effect-assessment was given to each RCT based
throughout the selection and analysis process. The execution of on the following criteria [48]:
Table 1
The translation of salutogenic principles into inclusion criteria.
Salutogenic principle Explanation Inclusion criteria

The participant as a whole Physical, mental, social and spiritual health are equally RCTs are included if they evaluated at least one
important, and all domains interact with one another physical and one psychosocial health outcome
The participant’s active involvement Adults with T2DM are involved in determining individual RCTs are included if they explicitly described
intervention strategies how the adults with T2DM were involved in the
development of the intervention and/or the
determination of individual intervention
strategies
The participant’s individual learning process An individual’s learning process leads to the discovery of RCTs are included if they included sessions
resources and self-examination that facilitate their coping dedicated to self-examination and coping
with the everyday challenges of living with T2DM
Table 2
Overview of all the inclusion and exclusion criteria for the selection of articles.
Criteria Included Excluded

Publication type 1) Articles in English 1) Articles not in English
2) Full-text available 2) Full text not available 3) Book chapters, editorials, conference papers, opinion
3) Original study papers, letters
Study design 1) RCTs 1) Observational studies

2) Qualitative studies
3) Reviews
4) Meta-analyses
5) Non-randomised interventions
6) Non-controlled interventions
Population 1) Adults (> 18 years) officially diagnosed with 1) Adults with other types of diabetes (e.g., type 1, gestational)
T2DM without severe (physical or mental) 2) Adults at risk of diabetes (e.g., prediabetes, metabolic syndrome)
health complications 3) Children/adolescents (< 18 years)
4) Adults with severe physical health complications (e.g., cardiovascular disease, renal
disease, cancer)
5) Adults with severe mental diseases (e.g., schizophrenia, bipolar disease, severe/
clinical depression)
6) Pregnant women
7) Cognitively impaired adults
Control 1) RCTs that compared the intervention with a 1) RCTs that compared the intervention with other types of interventions/treatments
control receiving usual care1 2) RCTs that compared the intervention with enhanced usual care2
3) RCTs that did not describe the control condition
Intervention 1) RCTs that explicitly described how adults 1) RCTs adopting a top-down approach (e.g., interventionists/deliverers determine
development with T2DM were involved in the develop- intervention strategies)
ment of the intervention and/or the deter- 2) RCTs that did not describe the development of the intervention strategy
mination of the intervention strategies
Intervention 1) RCTs that included sessions dedicated to 1) Pharmacological or surgical interventions

strategy self-examination and coping 2) Lifestyle interventions using behavioural-oriented and/or traditional didactic
strategies
3) RCTs evaluating the cost-effectiveness of an intervention
4) Interventions aiming to improve non-T2DM related matters (e.g., to treat alcohol
abuse, to improve sleep quality)
Outcomes 1) RCTs that measured at least one physical and 1) RCTs that measured health outcomes in only one health dimension
one psychosocial health outcome 2) RCTs with only behavioural outcomes (e.g., self-management behaviours) and/or
cognitive outcomes (e.g., knowledge level)
1
Usual care = care representative of standard medical treatment for T2DM in the corresponding county/area.
2
Enhanced usual care = care representative of standard medical treatment for T2DM in the concerning county/area combined with extra diet, education or mental guidance.
Table 3
Explanation of the information extracted from the RCTs. Note 1: Physical health outcomes were defined as measures indicating body composition (e.g., body mass index
(BMI)), metabolic health (e.g., blood pressure), or T2DM severity (e.g., HbA1c). Note 2: Psychosocial health outcomes were defined as measures indicating (positive or
negative) wellbeing (e.g., quality of life (QoL)), perceived control over life and/or disease (e.g., self-efficacy), and social health (e.g., social support).
Characteristic Data extracted

Study population Mean age, country, sample size, N% female and specific recruitment conditions.
Intervention Theoretical framework(s) and methods of involving participants during the intervention development process.
development
Intervention Description of overall intervention content and self-examination strategies, delivery setting, deliverer(s), delivery fidelity, intervention intensity
strategies and follow-up period.
Outcomes The physical and psychosocial health outcomes measured closest to the end of the intervention were extracted, as well as the outcomes measured
in a follow-up period, where available (mean SD or mean SE or mean95% CI, and corresponding significance levels). To provide a clear
overview the psychosocial health outcomes, the 90 different concepts were clustered into 15 categories (supplementary materials, Table C.1). For
example, the QoL category covers general and diabetes-specific QoL measurements. Cognitive measures (e.g., knowledge level) and behavioural
measures (e.g., performing self-management behaviours) were not extracted.
Small effect: >50% of the outcomes had an effect size of 0.50 3. Results
Medium effect: >50% of the outcomes had an effect size of
0.50–0.80 3.1. Description of the search
Large effect: >50% of the outcomes had an effect size of >0.80.
Finally, the characteristics of the SOIs with significant results for Fig. 1 provides an overview of the article selection procedure
both physical and psychosocial health and those with no significant and the reasons for exclusion. The search resulted in the
results for either physical or psychosocial health were compared and identification of 3591 articles. After the removal of duplicates,
qualitatively summarised. title, abstract and full-text screening, and the checking of reviews
Fig. 1. Preferred reporting items for systematic reviews and the meta-analysis flowchart. See Table 2 for a detailed explanation of the reasons for exclusion based on
publication type, study design, population, control, intervention development, intervention strategy and outcomes.
for relevant references, 28 RCTs were included in the final analysis. USA [49,50,59–61,51–58], followed by Europe [62–68], Asia
Most studies were excluded based on study design. All of the [69–75] and Australia [76]. The mean age of the study population
included RCTs were published between 2004 and 2018. was >50 for all studies except one [53]. RCTs recruited participants
for the SOIs on the basis of age (>40 years) [56,62,70,73], poor
3.2. General characteristics glycaemic control (>7.5% HbA1c) [50,51,54,56,61,63,65,66,69,73],
low SES [50–53,55–57,59,63], and/or specific ethnicity or culture
3.2.1. Study population [51,51,52,53,55,56,59]. The average N% female was 59 (SD = 21),
Sample size used in the RCTs varied from 25 to 668 participants, although in two RCTs, the gender distribution was unknown
with an average of 174 (SD = 147). Most SOIs were conducted in the [56,74].
3.2.2. Intervention characteristics 3.3. Realisation of the salutogenic principles
3.2.2.1. Intervention intensity. The average number of sessions was 3.3.1. The participant as a whole
12.84 (SD = 19.08). Most SOIs involved between five and 10
sessions [52,56,76,58,61,62,66,68,70–72]. The average duration 3.3.1.1. Health assessment. Physical health outcomes were the
was 30.21 (SD = 25.51) weeks, with most SOIs lasting for >20 primary outcomes in most SOIs [49,50,74,51,53,54,62,66,67,70,73],
weeks [49,50,63–65,67,70,71,75,51,53,55–57,60–62]. The average with HbA1c being the most commonly measured physical health
contact time (i.e., number of sessions session duration) was outcome (n = 27; supplementary materials, Table D.1). Psychosocial
19.40 (SD = 27.73) hours, with most having >10 h contact time health outcomes were the primary outcomes in ([71,75]), with self-
[51,52,74,75,54,55,58,59,67–69,72]. efficacy being the most commonly measured psychosocial health
outcome (n = 16; supplementary materials, Table E.1). Both physical
3.2.2.2. Theoretical framework. 19 SOIs were based on a theoretical and psychosocial health outcomes were the primary outcomes in
framework [49,51,66–69,71–75,52,54,56,57,59,61,62,65]. Most ([52,55,56,61,63–65,68,76].) In ([69]), physical and psychosocial
used a theoretical framework that focused on the process of health measures were both secondary outcomes. In ([58–60,72]), it
people gaining empowerment (empowerment theory was unclear whether the health outcomes were primary or
[57,62,66,67,73,74]) and on expectations of confidence in one’s secondary outcomes.
ability to take action (social cognitive theory [54,59,68,72],
self-efficacy theory [69,71]). 3.3.2. The participant’s active involvement
Three strategies to actively involve participants in the
3.2.2.3. Single vs. multicomponent. Six SOIs were single-component development of interventions strategies were identified:
interventions, meaning that collaborative goal-setting was the only
intervention strategy used [50,57,63,65,70,73]. The rest were 1 Formative research (both quantitative and qualitative) was
multicomponent, meaning that collaborative goal-setting was used for intervention development in 13 SOIs [49,51,74,75,53–55,
combined with at least one other strategy, including education 58,59,68,71,72], either to align interventions with the patient
[51,52,66–69,71,72,74–76,53,54,56,58–62], self-monitoring blood priorities, preferred topics and opinions on how they want to work
glucose (SMBG) [49,51,53,59,62,64,74], nutritional therapy on their health [49,53,55,59,68,72,75]; to align them with specific
[49,52,55,58–60,74], stress management [52,55,58–61] and/or cultures [49,51,53–55,59,72,74]; or to align them with learning
exercise therapy [49,55]. styles [59]. Formative research was also used to provide inputs on
intervention feasibility, format, and delivery [54,55,59,75], as well
3.2.2.4. Delivery setting. The SOIs were delivered in a group as educational content [59,71,74].
setting [49,52,54,55,58,67–69,72,74], an individual setting 2 Pre-testing the intervention and adjusting it according to
[50,53,69,70,73,56,57,60,61,63–66], or in a combination of participant feedback featured in seven SOIs [51,52,55,61,64,68,69].
both [51,55,59,62,71]. Individual SOIs mostly combined in- This led to modifications of the exercises, communication strategies,
person sessions with phone calls, except for two delivered solely teaching methods [51,52,55,68], and/or tools and measurement
over the phone [60,69] and one delivered solely in-person [64]. instruments [52,69]. Pre-testing identified both important aspects to
In two SOIs, the setting was determined by the participant’s make the intervention more culturally sensitive [52] and processes
preference [62,76]. that influence the implementation of lifestyle changes in daily
life [61].
3.2.2.5. Deliverers. SOIs were delivered by medical health 3 Tailoring the intervention to the unique characteristics of specific
professionals [49,53,69,56,57,61,62,64,66–68], a multidisciplinary individuals featured in 14 SOIs [50,56,70,72,73,76,57,60–63,65–67].
team [51,55,59,63,70,72,75], community health workers (CHWs) Tailoring was usually based on a conversation between the
[50,52,71,74], peers [54,58], researchers [73,76] and mental health participants and the deliverers at the baseline. The goal of this
professionals [60,65]. The multidisciplinary teams consisted of conversation was to uncover personal values, priorities, illness
either medical professionals and CHWs/peers [51,55,59,75], medical perceptions, impacts on daily life and expectations, followed by
and mental health professionals [70,72], or CHWs and peers [63]. personal goal-setting. Four SOIs instead used psychosocial and
metabolic questionnaires [51,57,64,66]. In some SOIs, the partic-
3.2.2.6. Delivery fidelity. Fidelity was guaranteed by 1) the training ipants had the opportunity to choose their preferred setting and
of the deliverers by the research team, (medical) experts, or special communication strategies [62], suitable activities [50,76] and/or
skill training [49,50,63–65,67,68,70,71,73–75,52,76,54,56–60,62]; educational sessions [53,62].
2) the assessment of the deliverers’ competence via video or
audiotaped sessions [50,51,53,54,56,58,64,65,67,74]; 3) the In a few SOIs [56,58,64], an exact explanation of the usage of the
supervision of the deliverers by the research team during the formative research, pilot-testing, and/or tailoring was either not
intervention [50–52,56,58,67,76]; and/or 4) an intervention given or was rather vague.
manual [52,54,58,59,68,70,75]. Seven SOIs used only training
[49,57,60,62,63,71,73], while the other three methods were always 3.3.3. The participant’s individual learning process
combined with at least one other method. In five SOIs, it was Three strategies that potentially facilitated self-examination
unknown whether and how delivery fidelity was ensured and self-reflection were identified:
[55,61,66,69,72].
1 Collaborative goal-setting was used in all SOIs. Goal-setting
3.2.2.7. Follow-up period. Less than half of the RCTs included an can be seen as a direct strategy for enhancing self-examination.
intervention-free follow-up period [52,58,59,62,66–68,72,73,76]. In general, the interventionists guided the participants in setting
The follow-up periods ranged from 12 to 96 weeks. The outcomes their own personal realistic goals and strategies or action plans
that were reassessed varied; some reassessed all outcomes for reaching these goals. In the majority of the SOIs, individual
[59,62,66,76], whereas others reassessed only HbA1c goal-setting was limited to self-management goals (i.e., goal-
[52,68,72,73]. One RCT reassessed the health outcomes of the setting for healthy nutrition, exercise, SMBG, medication
intervention group only [58]. adherence and foot care). A total of 11 SOIs used individualised
770
Table 4
Effect sizes of the physical and psychosocial outcomes used in each SOI. Note 1: Only SOIs with a moderate-to-strong quality were included in this table. Note 2: Categorisation based on reported statistical significance level of 0.05.
Note 3: Effect sizes were calculated based on the achieved means after intervention as provided in the studies. Calculations of the effect sizes were based on previous literature ([77]). Only studies with statistical significant outcomes
were given an overall effect assessment. Overall effect assessments include: small effect (>50% of the outcomes have an effect sizes 0.50); medium effect (>50% of the outcomes have an effect size between 0.50-0.80); and large
effect (>50% of the outcomes have an effect size >0.80). Note 5: HbA1c = glycated haemoglobin; FBG = fasting blood glucose; BMI = body mass index; BW = body weight; WC = waist circumference; SBP = systolic blood pressure;
DBP = diastolic blood pressure; LDL = low-density lipoprotein cholesterol; HDL = high-density lipoprotein cholesterol; TC = total cholesterol; TG = triglycerides; UC = urinary cortisol; A:C = albumin to creatine ratio; TS = total
symptoms; SS = symptoms severity; QoL = quality of life; SE = self-efficacy. Note 6: Effect sizes of psychosocial outcomes are expressed in the scores of the measurement instruments. Measurement instruments for each psychosocial
outcome can be found in Table C.1 in the supplementary materials. *Small-large effect: of the total of five outcomes, two outcomes had a large effect, and two had a small effect. **Small-medium effect: equal number of outcomes
with a small and medium effect. ***Effect sizes for these outcomes could not be calculated.
SOI Significant physical health Non-significant physical Significant psychosocial health Non-significant psychosocial Overall effect
outcome(s) with effect size(s) health outcome(s) with outcome(s) with effect size(s) health outcome(s) with effect
effect size(s) size(s)
Nelson et al. [50] HbA1c 0.08% BMI 0.18 kg/m2 SBP 0.05 mmHg Social burden 0.19 Phys. QoL 0.14 Psych. Qol 0.05 Diabetes-specific Small effect
2017 DBP 0.08 mmHg TC:HDL 0.12 QoL 0.14
Samuel- [49] HbA1c 0.82% BMI SBP 0.16 mmHg DBP 0.49 mmHg Depressive symptoms 1.11 Perceived diabetes Phys. QoL 0.28 Psych. QoL 0.07 Family problem- Large effect
Hodge et al. 1.53 kg/m2 BW 1.45 kg control 0.76 Family support for diet 0.76 Family solving communication 0.58 Unresolved family
C.M.M. Polhuis et al. / Patient Education and Counseling 103 (2020) 764–776
2017 support for physical activity 1.01 Family diabetes conflict 0.77
cohesion 0.9
Wichit et al. [69] HbA1c 0.23% Diabetes-specific SE 1.35 Perceived therapeutic Phys. QoL 0.08 Psych. QoL 0.55 Small-large
2017 efficacy 1.06 effect*
Browning [70] HbA1c 0.07% FBG 0.07 mmol/dL BMI 0.09 kg/m2 Psychological distress 0.19 Phys. QoL 0.03 Psych. QoL 0.08 Social- Small effect
et al. 2016 BW 0.08 kg WCmen 0.47 cm WCwomen 0.09 cm relationship QoL 0.08 Environment QoL 0.01
HCmen 0.2 cm HCwomen 0.06 cm SBP 0.29 mmHg Diabetes-specific SE 0.01
DBP 0.1 mmHg LDL 0.1 mmol/L HDLmen
0.13 mmol/L HDLwomen 0.15 mmol/L TC
0.13 mmol/L TG 0.04 mmol/L
Kim et al. [51] HbA1c 0.59% FBG 0.47% SBP 0.11 mg/dL DBP 0.24 mg/dL HDL 0.11 mg/dL Diabetes-specific QoL0.94 Depression 0.17 Attitude toward diabetes 0.51 Small effect
2015 LDL 0.02 mg/dL TC TG 0.04 mg/dL Diabetes-specific SE 0.61
0.07 mg/dL
Protheroe [63] HbA1c 0.41 QoL 0.26 Diabetes-specific QoL 0.00 Health –
et al. 2016 status Physical 0.05 Mental 0.32 Wellbeing 0.18
Illness perceptions 0.07
Shakibazadeh [72] HbA1c 0.42% Diabetes-specific SE 1.25 Health beliefs 0.89 Depression 0.08 Small-large
et al. 2016 Attitude Positive 0.91 Negative 0.3 Patient- effect
satisfaction 0.87 Stigma 0.41
Wagner et al. [52] HbA1c 0.02% UC 0.01 Depressive symptoms 0.09 Anxiety symptoms Diabetes distress 0.00 Self-reported health 0.05 Small effect
2016 0.08
Chen et al. [73] HbA1c 0.4% Diabetes-specific QoL1.07 Diabetes-specific SE Large effect
2015 1.0
Garcia et al. [53] TC 0.69 mg/dL Total HbA1c 0.00% SBP 0.11 mmHg DBP 0.16 mmHg Diabetes-specific SE 0.67 Diabetes-specific QoL 0.26 Small effect
2015 symptoms 0.46 number LDL 0.53 mg/dL HDL 0.05 mg/dL TG 0.38 mg/dL
Karhula et al. [64] WC 0.46 cm HbA1c 0.17% BW 0.15 kg SBP 0.02 mmHg DBP QoL Phys. 0.12 Psych. –4.2 Phys. functioning 0.06 Small effect
2015 –0.8 mmHg LDL –0.06 mg/dL HDL –0.03 mg/dL Mental health 0.08 Role-physical 0.00 Bodily pain
TC –0.11 mg/dL TG 2.11 mg/dL 0.14 Soc. functioning 0.17 General health 0.2
Vitality 0.22 Role-emotional 0.34
Sinclair et al. [54] HbA1c 0.13% Diabetes distress 0.02 Small effect
2013
Keogh et al. [65] HbA1c 0.33% BMI 0.45 kg/m2 SBP 0.21 mmHg DBP Wellbeing Negative 0.47 Positive 0.88 Energy 1.16 Illness perceptions Consequences 0.52 Timeline Small-medium
2011 0.16 mmHg General 1.02 Diabetes-specific SE 1.07 Illness 0.28 effect**
perception Personal control 0.81 Treatment
control 0.59 Symptoms 0.55 Concern 0.67
Understanding 0.89 Emotional rep. 0.62 Family
support 0.54 Non-support 0.44
Toobert et al. [55] HbA1c 0.33% BMI Problem-solving ability 0.75 SE 0.00 Social support 0.75 Small-medium
2011 0.4 kg/m2 effect**
Wolever [60] HbA1c 0.27% SE 0.72 Social support 0.2 Benefit finding 0.5 QoL 0.24 Perceived stress 0.34 Appraisal of Small effect
et al. 2011 diabetes 0.74
Anderson [57] HbA1c 0.15% Diabetes-specific QoL 0.15 Diabetes-specific SE Depressive symptoms 0.12 Instrumental Small effect
et al. 2009 0.08 Satisfaction with care 0.2 diabetes self-management SE 0.05
self-management plans as a tool for goal-setting, which were

revised if necessary at every subsequent session
Small effect
Small effect
Small effect
[50,57,75,58,61–65,69,73]. In some SOIs, goal-setting was
further delimited to only one facet of T2DM self-management
(e.g., body weight [49]). Few SOIs allowed for goal-setting in
–
other domains, such as goals for managing stress and depression

Diabetes-specific SE*** Satisfaction with daily
[60,76] and reframing life’s adversities within a more positive

perspective [51]. Group sharing of experiences, feelings, and
progress towards goals was part of the intervention in 12 SOIs
Wellbeing 0.00 Diabetes distress 0.01
[49,51,74,75,54,58,59,65,68,69,71,72]. In three of these, family

Fatigue 0.15 Self-rated health 0.13
members were involved [49,65,69]. Motivational counselling

was used for goal-setting in 11 SOIs [50,51,73,56,60,64,65 ,69–72].
Fewer than half of the SOIs clearly explained that the reflection
upon and revision of goals was part of goal-setting
Empowerment 0.58
[50,52,75,76,54,60,64,66–69,71]; however, in most of these,

reflection again related only to self-management, with few
offering participants room for reflection on their feelings about
life with T2DM and distress [60,66,76].
life***
2 SMBG enables examination of the interactions between the

body, behaviour and mental state. Participants were encouraged
to SMBG at home on a regular basis in seven SOIs
[49,51,53,59,62,64,74]. Some provided SMBG devices at the
Depression 0.47 Diabetes-specific SE 0.38
beginning of the intervention. SMBG values were commonly

Distress 0.19 Integration 0.42 Treatment
used as the starting point for evaluating personal goals.

Confidence in diabetes knowledge***
3 Stress management therapy has the potential to stimulate self-

examination. It was part of the SOI in six RCTs [52,55,58–61].
These exercises included: mindfulness, guided meditation,
breathing exercises, body-scan exercises, thermal biofeedback,
Patient activation 0.18
yoga, progressive deep relaxation and receptive imagery [52,55].

Two SOIs offered professional psychosocial support for stress
satisfaction 2.1
management therapy [60,61].
Three strategies for enhancing T2DM-specific coping resources

were identified:
1 Education on T2DM and self-management can be a valuable

HbA1c 0.26% BMI 0.14 kg/m2 BW 0.44 kg WC 0.5
resource for coping with the practical and emotional aspects of

T2DM. Education was part of the SOI in 19 RCTs [51,52,66–69,
71,72,74–76,53,54,56,58–62]. Most SOIs stressed that education
was delivered interactively (e.g. [71],) and was based on the
priorities of the group/individual (e.g. [61,72],).
2
HbA1c 0.08% BMI 0.27 kg/m2
HbA1c 0.00% BMI 0.27 kg/m
2 Nutritional therapy can strengthen food and cooking resources,

HbA1c 0.07% BW 0.02 kg
making it easier to cope with T2DM nutritional guidelines.

Various nutritional therapies were used as part of the SOI in
seven RCTs [49,52,55,58–60,74], including the provision of a
certain diet, offering personalised dietary advice, cooking
classes, and help with reading food labels and buying healthy
foods.
cm
3 Exercise therapy includes guiding, monitoring, and motivating

exercise behaviour, which may develop/strengthen resources
important for implementing and maintaining exercise in everyday
life. Two SOIs included exercise therapy [49,55]. One ([55])
recommended 30 min of moderate aerobic activity most days per
week and the performance of 10 strength-training exercises twice
a week, while the other ([49]) encouraged exercise by providing
incentives that could be redeemed for items.
3.4. Data synthesis

[66]
[58]
[67]
[61]
3.4.1. Effect sizes

Sigurdardottir
In Table 4, the physical and psychosocial health outcomes of

Whittemore
et al. 2009
et al. 2004
et al. 2007
Lorig et al.
each SOI are displayed with the corresponding effect sizes. Twelve
Adolfsson
SOIs had a small effect, two a small-medium effect, two a small-

2009
large effect, and two a large effect. There was a large variation in
how many and which types of outcomes were measured.
Table 5
Categorisation of SOIs based on the significant results in physical and psychosocial health.
Significant result(s) in psychosocial health No significant result(s) in psychosocial health

Significant result(s) in physical health Garcia et al. 2015 [53] Karhula et al. 2015 [64]
Anderson et al. 2009 [57] Sinclair et al. 2013 [54]
Kim et al. 2015 [51]
Shakibazadeh et al. 2016 [72]
Keogh et al. 2011 [65]
Toobert et al. 2011 [55]
Samuel-Hodge et al. 2017 [49]
No significant result(s) in physical health Nelson et al. 2017 [50] Protheroe et al. 2016 [63]
Browning et al. 2016 [70] Sigurdardottir et al. 2009 [66]
Wagner et al. 2016 [52]
Wolever et al. 2011 [60]
Lorig et al. 2009 [58]
Adolfsson et al. 2007 [67]
Whittemore et al. 2004 [61]
Wichit et al. 2017 [69]
Chen et al. 2015 [73]
Note: Only SOIs with a moderate-to-strong quality were included in this table.
Table 5 shows that seven SOIs reported significant results in characteristics, and the salutogenic criteria. Although there were
both physical and psychosocial health (hereafter referred to as fewer non-effective than effective SOIs, six differences were
effective SOIs), two reported significant results in physical health, notable:
nine reported significant results in psychosocial health, and two
reported no significant results (hereafter referred to as non- 1 Most effective SOIs were performed in North America
effective SOIs). The effect sizes of the effective SOIs varied from [47,52,54,56,58] and were culturally targeted [47,52,54,56,70],
small to large, while the effects of the non-effective SOIs were whereas the non-effective SOIs were mostly performed in
small. Europe and were not culturally targeted [61,64].
2 Effective SOIs typically had 10 sessions [47,52,54,56,58,70]
3.4.2. Comparison of effective and non-effective SOIs and >20 h of contact time [47,52,56,70], whereas all non-
In Table 6, the seven effective and two non-effective SOIs are effective SOIs had <10 sessions and <10 h of contact time
compared in terms of the study population, intervention [61,64].
Table 6
Comparison of effective and non-effective SOIs.
Characteristics Effective SOIs (n = 7) Non-effective SOIs (n = 2)
General Study population Sample size (mean 203 85.5 67 9.00

characteristics SD)
Country USA (n = 5/7) European (n = 2/2)
Sex > 50% female (n = 4/7) > 50% male (n = 2/2)
Health condition Poor control (2/7) Poor control (n = 2/2)
Overweight (1/7)
Low SES Yes (4/7) Yes (n = 1/ 2)
Ethnicity/culture Latino-Americans (n = 2/7) - (n = 0/2)
African-Americans (n = 1/7)
Korean-Americans (n = 1/7)
Intervention characteristics Sessions (number) 10–20 (n = 5/7) 0–10 (n = 2/2)
Contact time (h) > 20 (n = 4/7) < 10 (n = 2/2)
Duration (week) > 24 (n = 4/7) < 24 (n = 2/2)
Follow-up period No (n = 6/7) No (n = 1/1)
Multi/single Multicomponent (goal-setting, education, Multicomponent (goal-setting,
component SMBG) (n = 5/7) education) (n = 1/2)
Delivery setting Group (n = 5/7) Individual (n = 2/2)
Deliverers One type of deliverer (n = 3/4) One type of deliverer (n = 1/2)
Delivery fidelity > 1 delivery fidelity method (n = 2/7) > 1 delivery fidelity method (n = 1/2)
Salutogenic The participant as a whole Use of theory Yes (n = 5/7) Yes (n = 1/2)
principles Physical health HbA1c (n = 7/7) HbA1c (n = 2/2)
outcome
Psychosocial health Self-efficacy (n = 6/7) Wellbeing (n = 2/2)
outcome
The participant’s active Participant Formative research (n = 5/7) Tailoring (n = 2/2)
involvement involvement Pre-testing (n = 2/7)
Tailoring (n = 2/7)
Culturally sensitive Yes (n = 4/7) No (n = 2/2)
The participant’s individual Self-examination Collaborative goal-setting (n = 7/7) Collaborative goal-setting (n = 2/2)
learning process strategies SMBG (n = 3/7)
Stress-management (n = 1/7)
Enhancing coping Education (n = 4/7) Education (n = 1/2)
resources Nutritional therapy (n = 2/7)
Exercise therapy (n = 2/7)
3 Most effective SOIs were group-based [47,52,56,70], whereas and qualitative measures may aid the interpretation of psychoso-
the non-effective SOIs were individually delivered [61,64]. cial health in the context of everyday life.
Accordingly, the group sharing of experiences was a common
part of goal-setting in the effective SOIs, whereas the non- 4.1.2. The participant’s active involvement
effective SOIs were focused mostly on individualised self- Different strategies to actively involve participants in the
management plans. intervention development process were observed, including
4 The effective SOIs measured self-efficacy [52,54,56,58,63,70], formative research, pre-testing, and tailoring to individual priori-
whereas none of the non-effective SOIs measured self-efficacy. ties. Most of the effective SOIs used formative research, whereas all
5 Most of the effective SOIs used formative research to involve non-effective SOIs tailored the intervention (Table 6). Formative
patients in intervention development [47,52,54,56,70], whereas research in the effective SOIs involved focus groups and/or
non-effective SOIs tailored the intervention strategy to individ- interviews with people with T2DM. All allowed adults with
ual priorities at the baseline [61,64]. T2DM to co-create the intervention to some extent: from deciding
6 Many effective SOIs implemented SMBG [47,52,54], whereas the which issues should be addressed [49], to deciding on the contents,
non-effective SOIs did not. frequency and format [55]. Co-created interventions may be more
effective than tailored interventions because they force academics
to work alongside adults with T2DM. This foregrounds the
4. Discussion and conclusion localized, lived experiences of T2DM making interventions
meaningful to everyday life. Although research is limited, some
4.1. Discussion recent studies using the PRECEDE-PROCEED model1 in T2DM
showed promising results for psychosocial health [81] and self-
In this systematic review, 28 RCTs were identified that complied management [82–84]2 . Unlike the SOIs included in this review, the
with predefined salutogenic principles. The characteristics of formative research in these studies consisted of questionnaires
the effective SOIs included: 1) development based on formative measuring predisposing, enabling and reinforcing factors [82–84].
research, 2) culturally targeted, and 3) delivered in 10–20 sessions 4) Formative research has the potential for high societal impact [85];
in group settings (Table 6). The magnitude of the effective SOIs varied however, more research is needed to determine which formative
from small to large effects (Table 4). To decide whether salutogenesis research strategies – quantitative, qualitative, or combined – are
is useful for T2DM lifestyle interventions, it is important to reflect on optimal.
the use of the salutogenic criteria and consider the extent to which The non-effective SOIs tailored the intervention to each patient
the SOIs were developed, executed, and evaluated in line with true at baseline. Tailoring has been found to be only marginally
salutogenic thought. The realisation of the salutogenic principles and successful for improving physical health and self-management
differences between effective and non-effective SOIs are discussed behaviours in individuals with chronic diseases [8,86]; however,
below. successful tailoring is complex because numerous factors may
moderate the health effects [87]. For example, tailoring on
4.1.1. The participant as a whole multiple levels (theoretical concepts, behaviour and demo-
It was assumed that, when both physical and psychosocial graphics) seems to be more successful than single-level tailoring
health outcomes were measured, these outcomes were also taken [87]. It was sometimes difficult to determine the exact amount of
into consideration in the development of the interventions. tailoring that had been used. Generally, the studies were tailored in
Indeed, this assumption could have led to the inclusion of response to patient behaviours, which might have been more
interventions that were not necessarily designed to improve effective if it was combined with tailoring based on theoretical
multiple health dimensions; however, limited and poor descrip- concepts, including attitudes, self-efficacy, stage/process of change
tions made it difficult to assess whether and to what extent an and social support [87,88]. In addition, only one of the SOIs
intervention was specifically targeted to certain outcomes. HbA1c described tailoring as being based on an individual’s personal
was the primary outcome in most RCTs, suggesting a stronger history with T2DM [61], whereas an understanding of someone’s
focus on physical than psychosocial health, whereas true life history and lived experiences with T2DM are considered to be
salutogenic interventions would be specifically designed to important starting points for health promotion using salutogenic
improve multiple health dimensions. Future (salutogenic) inter- interventions [42,89]. The future tailoring of interventions should
ventions should include a detailed content description and involve all these aspects.
argumentation for the chosen outcomes.
Furthermore, there was large variation in how many and which 4.1.3. The participant’s individual learning process
types of outcomes were measured, especially regarding psychoso- Collaborative goal-setting is widely recommended and used in
cial health, making a fair comparison difficult. HbA1c is a valid T2DM interventions [90,91] and it seems to be more effective
marker for physical health [78], but valid markers for psychosocial when delivered in multi-component interventions [5,10]. Despite
health in T2DM are less straightforward. In addition, there was this knowledge, research is still inconclusive about the effective-
great heterogeneity in the definitions and instruments used for ness of any particular intervention strategy for managing T2DM
psychosocial health, making the comparison of intervention effects [8,10,92]. Both effective and non-effective SOIs applied goal-
even more problematic. For example, diabetes-specific QoL and setting and were mostly multicomponent (Table 6); therefore,
diabetes distress were both measured with the Problem Areas in what may have caused the differences in their effectiveness?
Diabetes scale, and five different instruments were used to First, goal-setting was focused on individualised self-manage-
measure diabetes-specific QoL (supplementary materials, ment plans in all non-effective SOIs, whereas most effective SOIs
Table C.1). Similar methodological issues regarding incoherent combined this more generally with the group sharing of
definitions of psychosocial health concepts and ways to measure experiences. This might be a crucial difference, because social
these were also observed in two recent systematic reviews on
obesity [79,80]. Evidently, there is a need for standardised and
validated instruments to lower heterogeneity; however, given that 1
A model in which participants are involved in each stage of the development,
psychosocial health is complex, quantitative measures alone may implementation and evaluation of an intervention [103].
not be sufficient for its evaluation. A combination of quantitative 2
These studies were not included as they did not fulfil all our inclusion criteria
support is a vital coping resource according to salutogenesis [22]. 4.3. Conclusion

Receiving and providing high-quality social support leads to
experiences of emotional closeness that enhance self-identity and This review contributes to the understanding of patient-centred
strengthen meaningfulness in everyday life [22,93–95]. On the interventions for adults with T2DM and the use of salutogenesis in
other hand, a recent meta-analysis showed that both individual this area. Most interventions that can, to a certain extent, be
and group delivery are beneficial for improving HbA1c [10]; considered salutogenic were found to improve physical health,
however, social peer support seems particularly beneficial for psychosocial health, or both; however, the heterogeneity of these
adults with T2DM in socially disadvantaged situations [10,96,97]. studies made it impossible to link and/or analyse specific
Second, SMBG was implemented more commonly in effective characteristics in relation to (specific) health outcomes. Although
than non-effective SOIs. Several meta-analyses have shown that limited, interventions based directly on salutogenesis have already
SMBG is an effective stand-alone intervention strategy for shown good results for people with mental disorders [89] and
improving HbA1c in the short term (e.g., [98,99]). Indeed, a recent T2DM [42]. Future research should explore how to purposefully
meta-analysis [88] suggested that feedback and monitoring design salutogenic interventions and study their effectiveness
strategies such as SMBG are essential for successful goal-setting. before we can conclude whether these approaches are more
SMBG provides direct feedback to individuals on how daily events, effective than traditional interventions.
choices and behaviours influence blood glucose levels, helping
them to better understand and manage their T2DM. In salutogenic 4.4. Practical implications
terms, SMBG is a resource in a self-regulating learning process
towards establishing self-identity [41,100]. Culturally targeted SOIs based on formative research and
Finally, an alternative explanation is that intervention intensity delivered in 10–20 (group) sessions seem to improve both physical
affected effectiveness: effective SOIs generally involved more and psychosocial health outcomes in adults with T2DM. These are
sessions (>10) and more contact time (>20 h) than non-effective important elements to further research and to take into account
SOIs. The evidence seems to suggest that more intensive inter- when developing T2DM lifestyle interventions based directly on
ventions (minimum 10 h contact time) are most effective, especially salutogenesis.
for HbA1c and weight loss [10,97,101].
Concerning the realisation of this salutogenic principle, it was Funding
assumed that goal-setting would enhance self-identity by initiat-
ing self-examination and reflective thinking; however, enabling The authors of this review received a grant from the Edema-
self-examination is a complex process that requires substantial Steernberg Foundation, Wageningen, The Netherlands a non-profit
training, supervision, specific skills and experience [102]. It was foundation that supports and initiates multidisciplinary research
often difficult to establish whether and to what extent the related to nutrition and eating behaviours.
deliverers were properly and sufficiently trained to do this.
Furthermore, in most SOIs, there was delimited freedom for Author contributions
participants to set goals, and aspects of self-examination were
rarely mentioned. To realise the optimal outcomes from a All authors were involved in the conceptualisation and
salutogenic perspective, interventions should allow more freedom methodology of the study. CMMP performed the systematic
to decide what issues should be addressed, and individuals should search, analysed the results and wrote the initial draft. The other
be stimulated to reflect not only on the goal-setting process, but authors commented on the analysis and edited the initial draft
also on illness perceptions and wellbeing in relation to everyday during all research and publication stages.
life [42,89].
Declaration of Competing Interest
4.2. Limitations The authors declare that there are no conflicts of interest.
This review has a number of strengths, including the inclusion Appendix A. Supplementary data
of a large number of RCTs, limited confounding variables, and
sufficient follow-up to assess cause and effect. For the first time, Supplementary material related to this article can be found, in
the salutogenic principles were compiled and applied as selection the online version, at doi:https://doi.org/10.1016/j.pec.2019.10.017.
criteria to provide an innovative perspective on moderators for
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Systematic Review of Salutogenic-Oriented Lifestyle Randomised Controlled Trials For Adults With Type 2 Diabetes Mellitus

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Patient Education and Counseling 103 (2020) 764–776

Contents lists available at ScienceDirect

Patient Education and Counseling

Systematic review of salutogenic-oriented lifestyle randomised

2.3. Quality assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 766

1. Introduction Salutogenesis complements current biomedical approaches by

2. Methods 2.5. Data synthesis

Salutogenic principle Explanation Inclusion criteria

Criteria Included Excluded

Study design 1) RCTs 1) Observational studies

Intervention 1) RCTs that included sessions dedicated to 1) Pharmacological or surgical interventions

Characteristic Data extracted

3.2.2. Intervention characteristics 3.3. Realisation of the salutogenic principles

self-management plans as a tool for goal-setting, which were

other domains, such as goals for managing stress and depression

[60,76] and reframing life’s adversities within a more positive

[49,51,74,75,54,58,59,65,68,69,71,72]. In three of these, family

members were involved [49,65,69]. Motivational counselling

[50,52,75,76,54,60,64,66–69,71]; however, in most of these,

2 SMBG enables examination of the interactions between the

beginning of the intervention. SMBG values were commonly

used as the starting point for evaluating personal goals.

3 Stress management therapy has the potential to stimulate self-

yoga, progressive deep relaxation and receptive imagery [52,55].

management therapy [60,61].

Three strategies for enhancing T2DM-speciﬁc coping resources

1 Education on T2DM and self-management can be a valuable

resource for coping with the practical and emotional aspects of

HbA1c 0.00% BMI 0.27 kg/m

2 Nutritional therapy can strengthen food and cooking resources,

making it easier to cope with T2DM nutritional guidelines.

3 Exercise therapy includes guiding, monitoring, and motivating

3.4. Data synthesis

3.4.1. Effect sizes

In Table 4, the physical and psychosocial health outcomes of

SOIs had a small effect, two a small-medium effect, two a small-

Signiﬁcant result(s) in psychosocial health No signiﬁcant result(s) in psychosocial health

Characteristics Effective SOIs (n = 7) Non-effective SOIs (n = 2)

General Study population Sample size (mean 203  85.5 67  9.00

support is a vital coping resource according to salutogenesis [22]. 4.3. Conclusion

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General Study population Sample size (mean 203 85.5 67 9.00