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Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Type 2 diabetes can be prevented through lifestyle changes, but sustainable and scalable lifestyle interventions are still lacking. Habit-based approaches offer an opportunity to induce long-term behavior changes. OBJECTIVE:The purposes of this study were to describe an internet-based lifestyle intervention for people at risk for type 2 diabetes targeted to support formation of healthy habits and explore its user engagement during the first 6 months of a randomized controlled trial (RCT). METHODS:The app provides an online store that offers more than 400 simple and contextualized habit-forming behavioral suggestions triggered by daily life activities. Users can browse, inspect, and select them; report their performances; and reflect on their own activities. Users can also get reminders, information on other users' activities, and information on the prevention of type 2 diabetes. An unblended parallel RCT was carried out to evaluate the effectiveness of the app in comparison with routine care. User engagement is reported for the first 6 months of the trial based on the use log data of the participants, who were 18- to 70-year-old community-dwelling adults at an increased risk of type 2 diabetes. RESULTS:Of 3271 participants recruited online, 2909 were eligible to participate in the RCT. Participants were randomized using a computerized randomization system to the control group (n=971), internet-based intervention (digital, n=967), and internet-based intervention with face-to-face group coaching (F2F+digital, n=971). Mean age of control group participants was 55.0 years, digital group 55.2 years, and F2F+digital 55.2 years. The majority of participants were female, 81.1% (787/971) in the control group, 78.3% (757/967) in the digital group, and 80.7% (784/971) in the F2F+digital group. Of the participants allocated to the digital and F2F+digital groups, 99.53% (1929/1938) logged in to the app at least once, 98.55% (1901/1938) selected at least one habit, and 95.13% (1835/1938) reported at least one habit performance. The app was mostly used on a weekly basis. During the first 6 months, the number of active users on a weekly level varied from 93.05% (1795/1929) on week 1 to 51.79% (999/1929) on week 26. The daily use activity was not as high. The digital and F2F+digital groups used the app on a median of 23.0 and 24.5 days and for 79.4 and 85.1 minutes total duration, respectively. A total of 1,089,555 habit performances were reported during the first 6 months. There were no significant differences in the use metrics between the groups with regard to cumulative use metrics. CONCLUSIONS:Results demonstrate that internet-based lifestyle interventions can be delivered to large groups including community-dwelling middle-aged and older adults, many with limited experience in digital app use, without additional user training. This intermediate analysis of use behavior showed relatively good engagement, with the percentage of active weekly users remaining over 50% at 6 months. However, we do not yet know if the weekly engagement was enough to change the lifestyles of the participants. TRIAL REGISTRATION:ClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478.

SUBMITTER: Harjumaa M

PROVIDER: S-EPMC7448183 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial.

Harjumaa Marja M Absetz Pilvikki P Ermes Miikka M Mattila Elina E Männikkö Reija R Tilles-Tirkkonen Tanja T Lintu Niina N Schwab Ursula U Umer Adil A Leppänen Juha J Pihlajamäki Jussi J

JMIR diabetes 20200811 3

<h4>Background</h4>Type 2 diabetes can be prevented through lifestyle changes, but sustainable and scalable lifestyle interventions are still lacking. Habit-based approaches offer an opportunity to induce long-term behavior changes.<h4>Objective</h4>The purposes of this study were to describe an internet-based lifestyle intervention for people at risk for type 2 diabetes targeted to support formation of healthy habits and explore its user engagement during the first 6 months of a randomized cont ...[more]

PMID: 32779571

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Project description:BackgroundDigital 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.ObjectiveWe aimed to investigate the longitudinal usage patterns of a digital healthy habit formation intervention, BitHabit, and the associations with changes in T2D risk factors.MethodsThis 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.ResultsMore 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.ConclusionsDistinct 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 registrationClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478.International registered report identifier (irrid)RR2-10.1186/s12889-019-6574-y.

Project description:ObjectiveTo describe the design of the Feel4Diabetes-intervention and the baseline characteristics of the study sample.DesignSchool- and community-based intervention with cluster-randomized design, aiming to promote healthy lifestyle and tackle obesity and obesity-related metabolic risk factors for the prevention of type 2 diabetes among families from vulnerable population groups. The intervention was implemented in 2016-2018 and included: (i) the 'all-families' component, provided to all children and their families via a school- and community-based intervention; and (ii) an additional component, the 'high-risk families' component, provided to high-risk families for diabetes as identified with a discrete manner by the FINDRISC questionnaire, which comprised seven counselling sessions (2016-2017) and a text-messaging intervention (2017-2018) delivered by trained health professionals in out-of-school settings. Although the intervention was adjusted to local needs and contextual circumstances, standardized protocols and procedures were used across all countries for the process, impact, outcome and cost-effectiveness evaluation of the intervention.SettingPrimary schools and municipalities in six European countries.SubjectsFamilies (primary-school children, their parents and grandparents) were recruited from the overall population in low/middle-income countries (Bulgaria, Hungary), from low socio-economic areas in high-income countries (Belgium, Finland) and from countries under austerity measures (Greece, Spain).ResultsThe Feel4Diabetes-intervention reached 30 309 families from 236 primary schools. In total, 20 442 families were screened and 12 193 'all families' and 2230 'high-risk families' were measured at baseline.ConclusionsThe Feel4Diabetes-intervention is expected to provide evidence-based results and key learnings that could guide the design and scaling-up of affordable and potentially cost-effective population-based interventions for the prevention of type 2 diabetes.

Project description:IntroductionAlthough the Diabetes Prevention Program and other clinical trials demonstrated the efficacy of intensive lifestyle interventions (ILI) and metformin to prevent type 2 diabetes, no studies have tested their comparative effects in pragmatic settings. This study was designed to compare the real-world effectiveness of ILI, metformin, and standard care among Hispanic women (Latinas) with prediabetes.Study designRCT.Setting/participantsNinety-two Latinas, who had a mean hemoglobin A1c of 5.9%, BMI of 33.3 kg/m2, and waist circumference of 97.4 cm (38.3 inches), were recruited from an urban community and randomly assigned to ILI, metformin, or standard care using 1:1:1 allocation. Data were collected from 2013-2015 and analyzed in 2016.InterventionThe 12-month ILI was adapted from the Diabetes Prevention Program's ILI and delivered by community health workers (promotoras) over 24 sessions. Metformin participants received 850 mg twice daily. Those randomized to standard care continued their regular medical care.Main outcome measuresWeight and secondary outcomes (waist circumference, blood pressure, hemoglobin A1c, fasting plasma glucose, insulin, and lipids) were assessed at baseline and 12 months.ResultsILI participants demonstrated significantly greater mean weight loss (-4.0 kg, 5.0%) than metformin (-0.9 kg, 1.1%) and standard care participants (+0.8 kg, 0.9%) (p<0.001). The difference in weight loss between metformin and standard care was not significant. The ILI group experienced a greater reduction in waist circumference than standard care (p=0.001), and a marginal improvement in hemoglobin A1c compared with metformin and standard care (p=0.063).ConclusionsIn the first comparative effectiveness trial of diabetes prevention treatments, a 12-month ILI produced significantly greater weight loss than metformin and standard care among Latinas with prediabetes. These data suggest that ILI delivered by promotoras is an effective strategy for preventing diabetes in this high-risk group, which may be superior to metformin. Future pragmatic trials involving larger samples should examine differences in diabetes incidence associated with these treatments.

Project description:BackgroundChildhood obesity is multi-factorial and determined to a large extent by dietary habits, physical activity and sedentary behaviours. Previous research has shown that school-based programmes are effective but that their effectiveness can be improved by including a parental component. At present, there is a lack of effective parental support programmes for improvement of diet and physical activity and prevention of obesity in children.Methods/designThis paper describes the rationale and design of a parental support programme to promote healthy dietary habits and physical activity in six-year-old children starting school. The study is performed in close collaboration with the school health care and is designed as a cluster-randomised controlled trial with a mixed methods approach. In total, 14 pre-school classes are included from a municipality in Stockholm county where there is large variation in socio-economic status between the families. The school classes are randomised to intervention (n = 7) and control (n = 7) groups including a total of 242 children. The intervention is based on social cognitive theory and consists of three main components: 1) a health information brochure; 2) two motivational interviewing sessions with the parents; and 3) teacher-led classroom activities with the children. The primary outcomes are physical activity in the children measured objectively by accelerometry, children's dietary and physical activity habits measured with a parent-proxy questionnaire and parents' self-efficacy measured by a questionnaire. Secondary outcomes are height, weight and waist circumference in the children. The duration of the intervention is six months and includes baseline, post intervention and six months follow-up measurements. Linear and logistic regression models will be used to analyse differences between intervention and control groups in the outcome variables. Mediator and moderator analysis will be performed. Participants will be interviewed.DiscussionThe results from this study will show if it is possible to promote a healthy lifestyle and a normal weight development among children from low-income districts with relatively limited efforts involving parents. Hopefully the study will provide new insights to the further development of effective programmes to prevent overweight and obesity in children.Trial registrationISRCTN: ISRCTN32750699.

Project description:BackgroundThe prevalence of overweight and obesity is on the rise worldwide with severe physical and psychosocial consequences. One of the most dangerous is hypertension. Lifestyle changes related to eating behaviour and physical activity are the critical components in the prevention and treatment of hypertension and obesity. Data indicates that the usual procedures to promote these healthy habits in health services are either insufficient or not efficient enough. Internet has been shown to be an effective tool for the implementation of lifestyle interventions based on this type of problem. This study aims to assess the efficacy of a totally self-administered online intervention programme versus the usual medical care for obese and overweight participants with hypertension (from the Spanish public health care system) to promote healthy lifestyles (eating behaviour and physical activity).MethodA randomized controlled trial will be conducted with 100 patients recruited from the hypertension unit of a public hospital. Participants will be randomly assigned to one of two conditions: a) SII: a self-administered Internet-based intervention protocol; and b) MUC-medical usual care. The online intervention is an Internet-delivered, multimedia, interactive, self-administered programme, composed of nine modules designed to promote healthy eating habits and increase physical activity. The first five modules will be activated at a rate of one per week, and access for modules 5 to 9 will open every two weeks. Patients will be assessed at four points: before the intervention, after the intervention (3 months), and at 6 and 12 months (follow-up). The outcome variables will include blood pressure, and Body Mass Index, as primary outcome measures, and quality of life and other lifestyle and anthropometrical variables as secondary outcome measures.DiscussionThe literature highlights the need for more studies on the benefits of using the Internet to promote lifestyle interventions. This study aims to investigate the efficiency of a totally self-administered Internet - +based programme for promoting healthy habits and improving the medical indicators of a hypertensive and overweight population.Trial registrationNCT02445833.

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Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial.

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Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial.

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