Effectiveness of workplace choice architecture modification for healthy eating and daily physical activity.

BACKGROUND: Modifying the choice architecture of behavioural contexts can facilitate health behaviour change, but existing evidence builds mostly on small-scale interventions limited in duration, targets, strategies, and settings. We evaluated the effectiveness of a one-year hybrid type 2 implementation-effectiveness trial aimed at promoting healthy eating and daily physical activity with subtle modifications to the choice architecture of heterogeneous worksites. The intervention was contextualised to and integrated into the routine operations of each worksite. Effectiveness was evaluated in a quasi-experimental pre-post design. METHODS: Intervention sites (n = 21) implemented a median of two (range 1-9) intervention strategies for healthy eating and one (range 1-5) for physical activity. Questionnaires pre (n = 1126) and post (n = 943) intervention surveyed employees' behavioural patterns at work (food consumption: vegetables/roots, fruit/berries, nuts/almonds/seeds, sweet treats, fast food, water; physical activity: restorative movement, exercise equipment use, stair use). The post-intervention questionnaire also measured employees' perception of and response to three intervention strategies: a packed lunch recipe campaign, a fruit crew-strategy, and movement prompts. Multi- and single-level regression models evaluated effectiveness, treating intervention as a continuous predictor formed of the site-specific dose (n intervention strategies employed) and mean quality (three-point rating per strategy halfway and at the end of the intervention) of implementation relevant to each outcome. RESULTS: Multinomial logistic regression models found the intervention significantly associated with a favourable change in employees' fruit and berry consumption (interaction effect of time and implementation p = 0.006) and with an unfavourable change in sweet treat consumption (p = 0.048). The evidence was strongest for the finding concerning fruit/berry consumption-an outcome that sites with greater dose and quality of implementation targeted by using strategies that reduced the physical effort required to have fruit/berries at work and by covering multiple eating-related contexts at the worksite. The quality of implementation was positively associated with the perception of (p = 0.044) and response to (p = 0.017) the packed lunch recipes, and with response to the fruit crew-strategy (p < 0.001). CONCLUSIONS: The results suggest that a contextualised, multicomponent choice architecture intervention can positively influence eating behaviour in diverse real-world settings over a one-year period, and that higher implementation quality can enhance intervention perception and response. However, outcomes may depend on the type of intervention strategies used and the extent of their delivery.

Acceptability of workplace choice architecture modification for healthy behaviours.

BACKGROUND: Altering the choice architecture of decision contexts can assist behaviour change, but the acceptability of this approach has sparked debate. Considering hypothetical interventions, people generally welcome the approach for promoting health, but little evidence exists on acceptance in the real world. Furthermore, research has yet to explore the implementers' perspective, acknowledging the multidimensionality of the acceptability construct. Addressing these knowledge gaps, this study evaluated the acceptability of a quasi-experimental implementation-effectiveness trial that modified the worksite choice architecture for healthy eating and daily physical activity. METHODS: Fifty-three worksites participated in the 12-month intervention and implemented altogether 23 choice architecture strategies (Mdn 3/site), including point-of-choice prompts and changes to choice availability or accessibility. Retrospective acceptability evaluation built on deductive qualitative content analysis of implementer interviews (n = 65) and quantitative analysis of an employee questionnaire (n = 1124). Qualitative analysis examined implementers' thoughts and observations of the intervention and its implementation, considering six domains of the Theoretical Framework of Acceptability: ethicality, affective attitude, burden, intervention coherence, opportunity costs, and perceived effectiveness. Quantitative analysis examined employees' acceptance (7-point Likert scale) of eight specific intervention strategies using Friedman test and mixed-effects logistic regression. RESULTS: Implementers considered the choice architecture approach ethical for workplace health promotion, reported mostly positive affective attitudes to and little burden because of the intervention. Intervention coherence supported acceptance through increased interest in implementation, whereas low perceived utility and high intensity of implementation reduced cost acceptance. Perceived effectiveness was mixed and varied along factors related to the implementer, social/physical work environment, employer, and employee. Employees showed overall high acceptance of evaluated strategies (Mdn 7, IQR 6.4-7), though strategies replacing unhealthy foods with healthier alternatives appeared less supported than providing information or enhancing healthy option availability or accessibility (p-values < 0.02). Greater proportion of male employees per site predicted lower overall acceptance (OR 4.4, 95% CI 1.2-16.5). CONCLUSIONS: Work communities appear to approve workplace choice architecture interventions for healthy eating and physical activity, but numerous factors influence acceptance and warrant consideration in future interventions. The study contributes with a theory-based, multidimensional evaluation that considered the perspectives of implementers and influenced individuals across heterogeneous real-world settings.

Two-decade trends and factors associated with overweight and obesity among young adults in Nepal.

Overweight and obesity are global epidemics in the adult population, and also affect young people. This study estimated the long-term trend (1996-2019) of overweight and obesity among young adults aged 18 to 29 years in Nepal by sex based on the World Health Organization (WHO) and Asian cut-offs for body mass index (BMI). We also investigated the demographic factors associated with overweight and obesity in the latest survey. This study utilized data from nationwide studies, Demographic and Health Surveys (DHSs) and WHO STEPwise approach to surveillance (STEPS) surveys. The trends in overweight and obesity were studied using trend analysis and joinpoint regression. Average annual percent changes (AAPCs) and their 95% confidence intervals (CIs) were calculated for the trends. Multivariable logistic regression was used to study the factors associated with overweight and obesity. The study findings showed significant upward trends in both overweight and obesity for women with AAPCs of 10.5 (95% CI 6.4-14.7) and 15.8 (95% CI 10.9-20.8) respectively. In the 25-29 age-group, the prevalence of overweight/obesity increased among women from 2.2% to 24.7% between 1996 and 2019, and among men from 8.8% to 25.4% between 2007 and 2019. Increased odds of overweight (AOR 9.15, 95% CI 6.64-12.60), and obesity (AOR 42.09, 95% CI 10.12-175.04) were found in 2019 compared to 1996. Older age and female sex, being married and urban residence were significantly associated with overweight and obesity. In conclusion, this study showed rapid upward trends in overweight and obesity among young adults in Nepal with an accelerated trend among women; the predictors for overweight were older age, female sex and married status, and those for obesity were older age, female sex, and urban residence.

A peer support program results in greater health benefits for peer leaders than other participants: evidence from the Kerala diabetes prevention program.

BACKGROUND: Peer support programs are promising approaches to diabetes prevention. However, there is still limited evidence on the health benefits of peer support programs for lay peer leaders. PURPOSE: To examine whether a peer support program designed for diabetes prevention resulted in greater improvements in health behaviors and outcomes for peer leaders as compared to other participants. METHODS: 51 lay peer leaders and 437 participants from the Kerala Diabetes Prevention Program were included. Data were collected at baseline, 12 months, and 24 months. We compared behavioral, clinical, biochemical, and health-related quality of life parameters between peer leaders and their peers at the three time-points. RESULTS: After 12 months, peer leaders showed significant improvements in leisure time physical activity (+ 17.7% vs. + 3.4%, P = 0.001) and health-related quality of life (0.0 vs. + 0.1, P = 0.004); and a significant reduction in alcohol use (-13.6% vs. -6.6%, P = 0.012) and 2-hour plasma glucose (-4.1 vs. + 9.9, P = 0.006), as compared to participants. After 24 months, relative to baseline, peer leaders had significant improvements in fruit and vegetable intake (+ 34.5% vs. + 26.5%, P = 0.017) and leisure time physical activity (+ 7.9% vs. -0.9%, P = 0.009); and a greater reduction in alcohol use (-13.6% vs. -4.9%, P = 0.008), and waist-to-hip ratio (-0.04 vs. -0.02, P = 0.014), as compared to participants. However, only the changes in fruit and vegetable intake and waist-to-hip ratio were maintained between 12 and 24 months. CONCLUSION: Being a peer leader in a diabetes prevention program was associated with greater health benefits during and after the intervention period. Further studies are needed to examine the long-term sustainability of these benefits.

Associations Between Engagement with the BitHabit Digital Lifestyle Intervention and Changes in Type 2 Diabetes Risk Factors.

Type 2 diabetes (T2D) can be prevented or delayed through a healthy lifestyle. Digital behavior change interventions (DBCIs) may offer cost-effective and scalable means to support lifestyle changes. This study investigated associations between user engagement with a habit-formation-based DBCI, the BitHabit app, and changes in T2D risk factors over 12 months in 963 participants at risk of T2D. User engagement was characterized by calculating use metrics from the BitHabit log data. User ratings were used as a subjective measure of engagement. The use metrics and user ratings were the strongest associated with improvements in diet quality. Weak positive associations were observed between the use metrics and changes in waist circumference and body mass index. No associations were found with changes in physical activity, fasting plasma glucose, or plasma glucose two hours after an oral glucose tolerance test. To conclude, increased use of the BitHabit app can have beneficial impacts on T2D risk factors, especially on diet quality.

The long-term effects of Kerala Diabetes Prevention Program on diabetes incidence and cardiometabolic risk: a study protocol.

INTRODUCTION: India currently has more than 74.2 million people with Type 2 Diabetes Mellitus (T2DM). This is predicted to increase to 124.9 million by 2045. In combination with controlling blood glucose levels among those with T2DM, preventing the onset of diabetes among those at high risk of developing it is essential. Although many diabetes prevention interventions have been implemented in resource-limited settings in recent years, there is limited evidence about their long-term effectiveness, cost-effectiveness, and sustainability. Moreover, evidence on the impact of a diabetes prevention program on cardiovascular risk over time is limited. OBJECTIVES: The overall aim of this study is to evaluate the long-term cardiometabolic effects of the Kerala Diabetes Prevention Program (K-DPP). Specific aims are 1) to measure the long-term effectiveness of K-DPP on diabetes incidence and cardiometabolic risk after nine years from participant recruitment; 2) to assess retinal microvasculature, microalbuminuria, and ECG abnormalities and their association with cardiometabolic risk factors over nine years of the intervention; 3) to evaluate the long-term cost-effectiveness and return on investment of the K-DPP; and 4) to assess the sustainability of community engagement, peer-support, and other related community activities after nine years. METHODS: The nine-year follow-up study aims to reach all 1007 study participants (500 intervention and 507 control) from 60 randomized polling areas recruited to the original trial. Data are being collected in two phases. In phase 1 (Survey), we are admintsering a structured questionnaire, undertake physical measurements, and collect blood and urine samples for biochemical analysis. In phase II, we are inviting participants to undergo retinal imaging, body composition measurements, and ECG. All data collection is being conducted by trained Nurses. The primary outcome is the incidence of T2DM. Secondary outcomes include behavioral, psychosocial, clinical, biochemical, and retinal vasculature measures. Data analysis strategies include a comparison of outcome indicators with baseline, and follow-up measurements conducted at 12 and 24 months. Analysis of the long-term cost-effectiveness of the intervention is planned. DISCUSSION: Findings from this follow-up study will contribute to improved policy and practice regarding the long-term effects of lifestyle interventions for diabetes prevention in India and other resource-limited settings. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry-(updated from the original trial)ACTRN12611000262909; India: CTRI/2021/10/037191.

Real-world effectiveness of digital and group-based lifestyle interventions as compared with usual care to reduce type 2 diabetes risk - A stop diabetes pragmatic randomised trial.

Background: No real-world randomised controlled trials (RCTs) have explored the effectiveness of lifestyle interventions based on multiple behaviour change theories and using combined digital and group-based face-to-face delivery to improve risk factors for type 2 diabetes (T2D). Methods: We conducted a one-year, multi-centre, unblinded, pragmatic RCT in primary healthcare using the habit formation, self-determination, and self-regulation theories among 2907 adults aged 18-74 years at increased T2D risk randomised into a digital lifestyle intervention group (DIGI, n = 967), a combined digital and group-based lifestyle intervention group (DIGI+GROUP, n = 971), and a control group receiving usual care (CONTROL, n = 969). We collected data on primary outcomes (diet quality by Healthy Diet Index [HDI], physical activity, body weight, fasting plasma glucose, 2-hour plasma glucose) and secondary outcomes (sedentary time, waist circumference, fasting plasma insulin) using digital questionnaires, clinical examinations, fasting blood tests, and 2-hour oral glucose tolerance tests. Main statistical analyses were performed using linear mixed-effects models adjusted for age, sex, and province. This RCT was registered with ClinicalTrials.gov, NCT03156478. Findings: The 2907 participants assigned were recruited between March 1st, 2017, and February 28th, 2018. Diet quality improved more (3·2 vs. 1·4 HDI points, p<0·001 for difference between groups, p'<0·001 for group*time interaction) and waist circumference tended to decrease more (-1·8 vs. -1·3 cm, p = 0·028, p' = 0·068) in DIGI+GROUP than in CONTROL. Fasting insulin tended to increase in CONTROL but not in DIGI (1·0 vs. 0·0 mU/L, p = 0·033, p' = 0·054) or in DIGI+GROUP (1·0 vs. 0·5 mU/L, p = 0·042, p' = 0·054). Good adherence to DIGI and DIGI+GROUP (≥median of 501 habits/year in DIGI, ≥5 of all 6 sessions in GROUP) was associated with improved diet quality and good adherence to DIGI with increased physical activity and decreased sedentary time. Interpretation: A lifestyle intervention based on multiple behaviour change theories and combined digital and group-based face-to-face delivery improves diet quality and tends to decrease abdominal adiposity and prevent an increase in insulin resistance. Good adherence improves the results of the interventions. Funding: Strategic Research Council at Academy of Finland, Academy of Finland, Novo Nordisk Foundation, and Finnish Diabetes Research foundation.

Immigrants' perspectives on healthy life and healthy lifestyle counseling: a focus group study.

BACKGROUND: Immigrants have a higher risk of developing chronic diseases than the general population, but there is a lack of knowledge about appropriate counseling models to promote their health. This study aimed to explore Asian and Russian immigrants' perspectives in Finland on healthy lifestyle and healthy lifestyle counseling to improve the quality of the counseling in primary health care services to prevent type 2 diabetes and other chronic diseases. METHODS: We conducted a qualitative study using semi-structured questions for eight focus groups. The participants were 46 adult immigrants (21 Asian and 25 Russian) living legally in Finland. Interviews were transcribed verbatim, coded, and analyzed using deductive content analysis. RESULTS: We identified three themes regarding healthy lifestyle: (1) limited knowledge on different dimensions of healthy lifestyle, (2) understanding the impact of culture and community on healthy living, and (3) changing the lifestyle to live healthier after immigration. Moreover, we found three themes regarding healthy lifestyle counseling: (1) shortcomings in health care for providing healthy lifestyle counseling, such as lack of educational materials and miscommunication, (2) influential individual factors for using healthy lifestyle counseling, such as stress, and (3) positive outcomes of healthy lifestyle counseling. CONCLUSION: Developing a culturally tailored healthy lifestyle counseling program for the enhancement of immigrants' knowledge regarding healthy lifestyle with consideration of cultural and linguistic aspects is recommended for preventing chronic diseases among immigrants.

Application of the Theoretical Framework of Acceptability to assess a telephone-facilitated health coaching intervention for the prevention and management of type 2 diabetes.

BACKGROUND: Lifestyle interventions focusing on diet and physical activity for the prevention and management of type 2 diabetes have been found effective. Acceptance of the intervention is crucial. The Theoretical Framework of Acceptability (TFA) developed by Sekhon et al. (2017) describes the multiple facets of acceptance: Affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. The aims of this study were to develop and assess the psychometric properties of a measurement scale for acceptance of a telephone-facilitated health coaching intervention, based on the TFA; and to determine the acceptability of the intervention among participants living with diabetes or having a high risk of diabetes in socioeconomically disadvantaged areas in Stockholm. METHODS: This study was nested in the implementation trial SMART2D (Self-management approach and reciprocal learning for type 2 diabetes). The intervention consisted of nine telephone-facilitated health coaching sessions delivered individually over a 6-month period. The acceptability of the intervention was assessed using a questionnaire consisting of 19 Likert scale questions developed using Sekhon's TFA. Exploratory factor analysis (EFA) was performed. RESULTS: Ratings from 49 participants (19 with type 2 diabetes and 30 at high risk of developing diabetes) in ages 38-65 were analyzed. The EFA on the acceptability scale revealed three factors with acceptable reliabilities: affective attitude (alpha 0.90), coherence and understanding (alpha 0.77), perceived burden (alpha 0.85), explaining 82% of the variance. Positive affect and coherence had high median scores and small variance. Median score for perceived burden was low, but with significant variance due to younger individuals and those at high risk reporting higher burden. CONCLUSIONS: The telephone-facilitated health coaching intervention was perceived as acceptable by the study population using a questionnaire based on Sekhon's TFA, with a wider variation in perceived burden seen among high risk and younger participants.

Sensory Appeal and Routines Beat Health Messages and Visibility Enhancements: Mixed-Methods Analysis of a Choice-Architecture Intervention in a Workplace Cafeteria.

Easier recognition and enhanced visibility of healthy options supposedly increase healthy choices, but real-world evidence remains scarce. Addressing this knowledge gap, we promoted nutritionally favourable foods in a workplace cafeteria with three choice-architectural strategies-priming posters, point-of-choice nutrition labels, and improved product placement-and assessed their effects on visual attention, food choices, and food consumption. Additionally, we developed a method for analysing real-world eye-tracking data. The study followed a pretest-posttest design whereby control and intervention condition lasted five days each. We monitored visual attention (i.e., total number and duration of fixations) and food choices with eye tracking, interviewed customers about perceived influences on food choices, and measured cafeteria-level food consumption (g). Individual-level data represents 22 control and 19 intervention participants recruited at the cafeteria entrance. Cafeteria-level data represents food consumption during the trial (556/589 meals sold). Results indicated that the posters and labels captured participants' visual attention (~13% of fixations on defined areas of interest before food choices), but the intervention had insignificant effects on visual attention to foods, on food choices, and on food consumption. Interviews revealed 17 perceived influences on food choices, the most common being sensory appeal, healthiness, and familiarity. To conclude, the intervention appeared capable of attracting visual attention, yet ineffective in increasing healthier eating. The developed method enabled a rigorous analysis of visual attention and food choices in a natural choice setting. We discuss ways to boost the impact of the intervention on behaviour, considering target groups' motives. The work contributes with a unique, mixed-methods approach and a real-world setting that enabled a multi-dimensional effects evaluation with high external validity.

Process evaluation of a pragmatic implementation trial to support self-management for the prevention and management of type 2 diabetes in Uganda, South Africa and Sweden in the SMART2D project.

INTRODUCTION: Type 2 diabetes (T2D) and its complications are increasing rapidly. Support for healthy lifestyle and self-management is paramount, but not adequately implemented in health systems. Process evaluations facilitate understanding why and how interventions work through analyzing the interaction between intervention theory, implementation and context. The Self-Management and Reciprocal Learning for Type 2 Diabetes project implemented and evaluated community-based interventions (peer support program; care companion; and link between facility care and community support) for persons at high risk of or having T2D in a rural community in Uganda, an urban township in South Africa, and socioeconomically disadvantaged urban communities in Sweden. RESEARCH DESIGN AND METHODS: This paper reports implementation process outcomes across the three sites, guided by the Medical Research Council framework for complex intervention process evaluations. Data were collected through observations of peer support group meetings using a structured guide, and semistructured interviews with project managers, implementers, and participants. RESULTS: The countries aligned implementation in accordance with the feasibility and relevance in the local context. In Uganda and Sweden, the implementation focused on peer support; in South Africa, it focused on the care companion part. The community-facility link received the least attention. Continuous capacity building received a lot of attention, but intervention reach, dose delivered, and fidelity varied substantially. Intervention-related and context-related barriers affected participation. CONCLUSIONS: Identification of the key uncertainties and conditions facilitates focus and efficient use of resources in process evaluations, and context relevant findings. The use of an overarching framework allows to collect cross-contextual evidence and flexibility in evaluation design to adapt to the complex nature of the intervention. When designing interventions, it is crucial to consider aspects of the implementing organization or structure, its absorptive capacity, and to thoroughly assess and discuss implementation feasibility, capacity and organizational context with the implementation team and recipients. These recommendations are important for implementation and scale-up of complex interventions. TRIAL REGISTRATION NUMBER: ISRCTN11913581.

Strengthening Capacity for Implementation Research Amid COVID-19 Pandemic: Learnings From the Global Alliance for Chronic Diseases Implementation Science School.

Objective: To describe the design, delivery and evaluation of the 3rd Global Alliance for Chronic Diseases (GACD) Implementation Science School (ISS), delivered virtually in 2020 for the first time. Methods: Since 2014, GACD has supported the delivery of more than ten Implementation Science Workshops for more than 500 international participants. It has also been conducting an annual ISS since 2018. In this study, we described the design, delivery and evaluation of the third ISS. Results: Forty-six participants from 23 countries in five WHO regions attended the program. The virtual delivery was well-received and found to be efficient in program delivery, networking and for providing collaborative opportunities for trainees from many different countries. The recently developed GACD Implementation Science e-Hub was found to be an instrumental platform to support the program by providing a stand-alone, comprehensive online learning space for knowledge and skill development in implementation research. Conclusion: The delivery of the virtual GACD ISS proved to be feasible, acceptable and effective and offers greater scalability and sustainability as part of a future strategy for capacity strengthening in implementation research globally.

Effects of a lifestyle intervention on depression and anxiety among adults at risk for diabetes in India: A secondary analysis of the Kerala Diabetes Prevention Program.

The impact of lifestyle interventions on diabetes and mental health conditions have been documented among people with diabetes. However, the mental health benefits of lifestyle interventions designed for diabetes prevention have not been systematically investigated among people at high risk of diabetes, particularly in low- and middle-income countries. We examined the effects of a 12-month peer support lifestyle intervention designed for diabetes prevention on depression and anxiety symptomology in the sample population of the Kerala Diabetes Prevention Program. Mixed-effects linear regression models were used to examine the effect of the intervention on depression and anxiety scores at 12 and 24 months in the total sample of 1007 adults at risk for diabetes and among those with mild-severe depressive or anxiety symptoms at baseline (n = 326 for depression; n = 203 for anxiety). Among all participants, the intervention group had a significantly higher reduction of depressive symptoms as compared to the control group at 12 months (mean diff score = -0.51; 95% CI: -0.95, -0.07; P = 0.02). This effect was not sustained at 24 months. There were no significant intervention effects for anxiety. Among those with mild-severe symptoms at baseline, the intervention group had a significantly higher reduction of depressive symptoms (mean diff score = -1.55; 95% CI -2.50, -0.6; P = 0.001) and anxiety symptoms (mean diff score = -1.64; 95% CI -2.76, -0.52; P = 0.004) at 12 months. The effect was sustained at 24 months for depression, but not anxiety. Lifestyle interventions designed for prevention of diabetes might improve depressive and anxiety symptoms in the short-term, particularly among those with mild-severe symptoms.

Individual and collective protective responses during the early phase of the COVID-19 pandemic in 10 different countries: Results from the EUCLID online survey.

BACKGROUND: In times of unprecedented infectious disease threats, it is essential to understand how to increase individual protective behaviors and support for collective measures. The present study therefore examines factors associated with individual and collective pathways. METHODS: Data was collected through an online survey from 4483 participants (70.8% female, M = 41.2 years) across 10 countries from April 15, 2020 to June 2, 2020 as part of the "EUCLID" project (https://euclid.dbvis.de). Structural equation modeling was used to examine individual and collective pathways across and within countries. RESULTS: Overall, the adoption of individual protective behaviors and support for collective measures were high. Risk perception on the individual level and perceived effectiveness at the collective level were positively associated with both individual protective behaviors and support for collective measures. Furthermore, the model explained considerable variance in individual (40.7%) and collective protective behaviors (40.8%) and was largely replicated across countries. CONCLUSIONS: The study extends previous research by demonstrating that individual risk perception and perceived effectiveness of collective measures jointly affect individual protective health behaviors and support for collective measures. These findings highlight the need to jointly consider a variety of behavioral actions against infectious disease threats, acknowledging interactions between individual and collective pathways.

Evaluating telehealth lifestyle therapy versus telehealth psychotherapy for reducing depression in adults with COVID-19 related distress: the curbing anxiety and depression using lifestyle medicine (CALM) randomised non-inferiority trial protocol.

BACKGROUND: There is increasing recognition of the substantial burden of mental health disorders at an individual and population level, including consequent demand on mental health services. Lifestyle-based mental healthcare offers an additional approach to existing services with potential to help alleviate system burden. Despite the latest Royal Australian New Zealand College of Psychiatrists guidelines recommending that lifestyle is a 'first-line', 'non-negotiable' treatment for mood disorders, few such programs exist within clinical practice. Additionally, there are limited data to determine whether lifestyle approaches are equivalent to established treatments. Using an individually randomised group treatment design, we aim to address this gap by evaluating an integrated lifestyle program (CALM) compared to an established therapy (psychotherapy), both delivered via telehealth. It is hypothesised that the CALM program will not be inferior to psychotherapy with respect to depressive symptoms at 8 weeks. METHODS: The study is being conducted in partnership with Barwon Health's Mental Health, Drugs & Alcohol Service (Geelong, Victoria), from which 184 participants from its service and surrounding regions are being recruited. Eligible participants with elevated psychological distress are being randomised to CALM or psychotherapy. Each takes a trans-diagnostic approach, and comprises four weekly (weeks 1-4) and two fortnightly (weeks 6 and 8) 90-min, group-based sessions delivered via Zoom (digital video conferencing platform). CALM focuses on enhancing knowledge, behavioural skills and support for improving dietary and physical activity behaviours, delivered by an Accredited Exercise Physiologist and Accredited Practising Dietitian. Psychotherapy uses cognitive behavioural therapy (CBT) delivered by a Psychologist or Clinical Psychologist, and Provisional Psychologist. Data collection occurs at baseline and 8 weeks. The primary outcome is depressive symptoms (assessed via the Patient Health Questionnaire-9) at 8 weeks. Societal and healthcare costs will be estimated to determine the cost-effectiveness of the CALM program. A process evaluation will determine its reach, adoption, implementation and maintenance. DISCUSSION: If the CALM program is non-inferior to psychotherapy, this study will provide the first evidence to support lifestyle-based mental healthcare as an additional care model to support individuals experiencing psychological distress. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12621000387820 , Registered 8 April 2021.

Digitally Supported Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Secondary Analysis of Long-Term User Engagement Trajectories in a Randomized Controlled Trial.

BACKGROUND: Digital health interventions may offer a scalable way to prevent type 2 diabetes (T2D) with minimal burden on health care systems by providing early support for healthy behaviors among adults at increased risk for T2D. However, ensuring continued engagement with digital solutions is a challenge impacting the expected effectiveness. OBJECTIVE: We aimed to investigate the longitudinal usage patterns of a digital healthy habit formation intervention, BitHabit, and the associations with changes in T2D risk factors. METHODS: This is a secondary analysis of the StopDia (Stop Diabetes) study, an unblinded parallel 1-year randomized controlled trial evaluating the effectiveness of the BitHabit app alone or together with face-to-face group coaching in comparison with routine care in Finland in 2017-2019 among community-dwelling adults (aged 18 to 74 years) at an increased risk of T2D. We used longitudinal data on usage from 1926 participants randomized to the digital intervention arms. Latent class growth models were applied to identify user engagement trajectories with the app during the study. Predictors for trajectory membership were examined with multinomial logistic regression models. Analysis of covariance was used to investigate the association between trajectories and 12-month changes in T2D risk factors. RESULTS: More than half (1022/1926, 53.1%) of the participants continued to use the app throughout the 12-month intervention. The following 4 user engagement trajectories were identified: terminated usage (904/1926, 46.9%), weekly usage (731/1926, 38.0%), twice weekly usage (208/1926, 10.8%), and daily usage (83/1926, 4.3%). Active app use during the first month, higher net promoter score after the first 1 to 2 months of use, older age, and better quality of diet at baseline increased the odds of belonging to the continued usage trajectories. Compared with other trajectories, daily usage was associated with a higher increase in diet quality and a more pronounced decrease in BMI and waist circumference at 12 months. CONCLUSIONS: Distinct long-term usage trajectories of the BitHabit app were identified, and individual predictors for belonging to different trajectory groups were found. These findings highlight the need for being able to identify individuals likely to disengage from interventions early on, and could be used to inform the development of future adaptive interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-6574-y.

Motivational determinants of physical activity in disadvantaged populations with (pre)diabetes: a cross-cultural comparison.

BACKGROUND: Understanding motivational determinants of physical activity (PA) is essential to guide the implementation of PA at individual and population level. Knowledge about the cross-cultural generalizability of these determinants is lacking and they have mostly been studied as separate factors. This study compares a motivational process model across samples from diverse populations with, or at risk of diabetes. METHODS: Measurement invariance of barrier identified regulation, barrier self-efficacy and social support was assessed in a rural Ugandan sample (n = 712) and disadvantaged samples with high proportions of immigrants in urban South Africa (n = 566) and Sweden (n = 147). These motivational determinants were then compared through multigroup structural equation modeling. RESULTS: The studied motivational constructs showed scalar invariance. Latent mean levels of perceived social support and barrier self-efficacy were lower in South Africa and Sweden. Structural models (for different PA outcomes) were not consistent across settings except for the association between perceived social support and identified regulation. Identified regulation was only associated with vigorous PA in Uganda and with moderate PA in South Africa. The association between social support and PA outcomes ranged from weak to not significant and the association between self-efficacy and PA was not significant. Self-reported PA was highest in Uganda and lowest in Sweden. Self-reported vigorous PA was significantly related to lower hemoglobin A1c levels, while moderate PA was not. CONCLUSIONS: Findings suggest that: 1) it is feasible to compare a motivational process model across diverse settings; 2) there is lower perceived social support and self-efficacy in the urban, migrant samples; 3) identified regulation is a more promising determinant of PA than self-efficacy or social support in these populations; 4) associations between motivational determinants and PA depend on the perceived type and/or intensity of PA; 5) perceived relatedness functions as a basic psychological need across diverse settings; and 6) people's perception of the PA they perform depends on their perceived level of intensity of PA which would have major implications for health promotion.

Ethnic differences in response to lifestyle intervention for the prevention of type 2 diabetes in adults: A systematic review and meta-analysis.

The risk of type 2 diabetes mellitus (T2DM) varies by ethnicity, but ethnic differences in response to diabetes prevention interventions remain unclear. This systematic review and meta-analysis assessed ethnic differences in the effects of lifestyle interventions on T2DM incidence, glycemic outcomes (fasting glucose, 2-h glucose, HbA1c ), anthropometric measures (weight, BMI, waist circumference), and lifestyle behaviors (physical activity, energy intake, energy from fat, fiber intake). MEDLINE, EMBASE, and other databases were searched (to June 15, 2020) for randomized and non-randomized controlled trials on lifestyle interventions (diet and/or physical activity) in adults at risk of T2DM. Ethnicity was categorized into European, South Asian, East and Southeast Asian, Middle Eastern, Latin American, and African groups. Forty-four studies were included in meta-analyses. Overall, lifestyle interventions resulted in significant improvement in T2DM incidence, glycemic outcomes, anthropometric measures, physical activity, and energy intake (all P < 0.01). Significant subgroup differences by ethnicity were found for 2-h glucose, weight, BMI, and waist circumference (all P < 0.05) but not for T2DM incidence, fasting glucose, HbA1c , and physical activity (all P > 0.05). Few studies in non-European groups reported dietary intake. Lifestyle interventions in different ethnic groups may have similar effects in reducing incidence of T2DM although this needs to be confirmed in further studies.

Prevention and management of type 2 diabetes mellitus in Uganda and South Africa: Findings from the SMART2D pragmatic implementation trial.

Health systems in many low- and middle-income countries are struggling to manage type 2 diabetes (T2D). Management of glycaemia via well-organized care can reduce T2D incidence, and associated morbidity and mortality. The primary aim of this study was to evaluate the effectiveness of facility plus community care interventions (integrated care), compared to facility only care interventions (facility care) towards improvement of T2D outcomes in Uganda and South Africa. A pragmatic cluster randomized trial design was used to compare outcomes among participants with T2D and those at high risk. The trial had two study arms; the integrated care arm, and the facility care arm; and in Uganda only, an additional usual care arm. Participants were enrolled at nine primary health facilities in Uganda, and two in South Africa. Participants were adults aged 30 to 75 years, and followed for up to 12 months. Primary outcomes were glycaemic control among participants with T2D, and reduction in HbA1c > = 3 mmol/mol among participants at high risk. Secondary outcomes were retention into care and incident T2D. Adjusted analysis revealed significantly higher retention into care comparing integrated care and facility care versus usual care in Uganda and integrated care versus facility care in South Africa. The effect was particularly high among participants at high risk in Uganda with an incident rate ratio of 2.46 [1.33-4.53] for the facility care arm and 3.52 [2.13-5.80] for the integrated care arm. No improvement in glycaemic control or reduction in HbA1c was found in either country. However, considerable and unbalanced loss to follow-up compromised assessment of the intervention effect on HbA1c. Study interventions significantly improved retention into care, especially compared to usual care in Uganda. This highlights the need for adequate primary care for T2D and suggest a role for the community in T2D prevention. Trial registration number: ISRCTN11913581.

Intervention Fidelity Focusing on Interaction between Participants and Facilitators in a Telephone-Delivered Health Coaching Intervention for the Prevention and Management of Type 2 Diabetes.

Self-management support and lifestyle interventions with an empowerment approach have been found to be effective strategies for health improvement among people at risk for or living with type 2 diabetes. Telephone coaching seems particularly efficient for individuals with low socioeconomic status and culturally and linguistically diverse backgrounds. In this mixed methods study, we investigate a telephone-delivered health coaching intervention provided by the diabetes project SMART2D (Self-Management Approach and Reciprocal learning for Type 2 Diabetes) implemented in socioeconomically disadvantaged areas in Stockholm, Sweden. We focus on the interaction between participants and facilitators as part of intervention fidelity. Recorded coaching sessions were scored using an interaction tool and analyzed by exploratory factor analysis and recorded supervisory discussions with facilitators analyzed using thematic analysis. The quantitative analysis showed that the intervention components were delivered as intended; however, differences between facilitators were found. The qualitative data highlighted differences between facilitators in the delivery, especially in relation to dietary and physical activity goalsetting. The level of language skills hindered the delivery flow and the tailoring of sessions to participants' needs led to different delivery styles. The interaction between facilitators and participants is an important aspect of intervention implementation. Tailoring of interventions is necessary, and language-skilled facilitators are needed to minimize barriers in intervention delivery.