Dataset Information

A Mobile Phone App for the Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus: Protocol for a Feasibility Randomized Controlled Trial.

ABSTRACT:

Background

Over 50% of women with a history of gestational diabetes mellitus (GDM) will develop type 2 diabetes (T2D) in later life. Asian women experience a disproportionate risk of both GDM and T2D compared to women from other ethnic backgrounds. Lifestyle interventions and behavior change can delay or even prevent the onset of T2D. We have developed a digitalized diabetes prevention intervention for the prevention of T2D in Malaysian women with GDM.

Objective

The protocol describes a randomized controlled trial (RCT) to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention, including a smartphone app and group support. Secondary aims are to summarize anthropometric, biomedical, psychological, and lifestyle outcomes overall and by allocation group, and to undertake a process evaluation.

Methods

This is a two-arm parallel feasibility RCT. A total of 60 Malaysian women with GDM will be randomized in the antenatal period to receive the intervention or standard care until 12 months post partum. The intervention is a diabetes prevention intervention delivered via a smartphone app developed based on the Information-Motivation-Behavioral Skills model of behavior change and group support using motivational interviewing. The intervention provides women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care. The Malaysian Ministry of Health's Medical Research and Ethics Committee has approved the trial (NMRR-21-1667-60212).

Results

Recruitment and enrollment began in February 2022. Future outcomes will be published in peer-reviewed health-related research journals and presented at national, regional, or state professional meetings and conferences. This publication is based on protocol version 2, January 19, 2022.

Conclusions

To our knowledge, this will be the first study in Malaysia that aims to determine the feasibility of a digital intervention in T2D prevention among women with GDM. Findings from this feasibility study will inform the design of a full-scale RCT in the future.

Trial registration

ClinicalTrials.gov NCT05204706; https://clinicaltrials.gov/ct2/show/NCT05204706.

International registered report identifier (irrid)

PRR1-10.2196/37288.

SUBMITTER: Benton M

PROVIDER: S-EPMC9501684 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

A Mobile Phone App for the Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus: Protocol for a Feasibility Randomized Controlled Trial.

Benton Madeleine M Iman Iklil I Goldsmith Kimberley K Forbes Angus A Ching Siew Mooi SM Papachristou Nadal Iliatha I Guess Nicola N Murphy Helen R HR Mohd Yusof Barakatun-Nisak BN Baharom Anisah A Mahamad Sobri Nur Hafizah NH Basri Nurul Iftida NI Salim Mazatulfazura Sf MS Ismail Irmi Zarina IZ Hassan Faezah F Ismail Khalida K Chew Boon How BH

JMIR research protocols 20220908 9

<h4>Background</h4>Over 50% of women with a history of gestational diabetes mellitus (GDM) will develop type 2 diabetes (T2D) in later life. Asian women experience a disproportionate risk of both GDM and T2D compared to women from other ethnic backgrounds. Lifestyle interventions and behavior change can delay or even prevent the onset of T2D. We have developed a digitalized diabetes prevention intervention for the prevention of T2D in Malaysian women with GDM.<h4>Objective</h4>The protocol descr ...[more]

PMID: 36074545

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Project description:The study addressed a significant gap in the profiling and understanding of the gut microbiota's influence on Malaysian Malay women with gestational diabetes mellitus (GDM). This prospective cohort study aimed to explore the intricate relationship between gut microbiota, dietary choices, and lifestyle factors among Malay women, both with and without GDM. The research specifically focused on participants during the second (T0) and third (T1) trimesters of pregnancy in Johor Bahru, Malaysia. In Part 1 of the study, a diverse pool of pregnant women at T0 was categorized into two groups: those diagnosed with GDM and those without GDM, with a total sample size of 105 individuals. The assessments encompassed demographic, clinical, lifestyle, and dietary factors at the T0 and T1 trimesters. Part 2 of the study delved into microbiome analysis, targeting a better understanding of the gut microbiota among the participants. Stool samples were randomly collected from 50% of the individuals in each group (GDM and non-GDM) at T0 and T1. The collected samples underwent processing, and 16s rRNA metagenomic analysis was employed to study the microbial composition. The results suggested an association between elevated body weight and glucose levels, poor sleep quality, lack of physical activity, greater intake of iron and meat, and reduced fruit consumption among women with GDM compared to non-GDM groups. The microbiome analysis revealed changes in microbial composition over time, with reduced diversity observed in the GDM group during the third trimester. The genera Lactiplantibacillus, Parvibacter, Prevotellaceae UCG001, and Vagococcus positively correlated with physical activity levels in GDM women in the second trimester. Similarly, the genus Victivallis exhibited a strong positive correlation with gravida and parity. On the contrary, the genus Bacteroides and Roseburia showed a negative correlation with omega-3 polyunsaturated fatty acids (PUFAs) in women without GDM in the third trimester. The study highlighted the multifaceted nature of GDM, involving a combination of lifestyle factors, dietary choices, and changes in gut microbiota composition. The findings emphasized the importance of considering these interconnected elements in understanding and managing gestational diabetes among Malaysian Malay women. Further exploration is essential to comprehend the mechanisms underlying this relationship and develop targeted interventions for effective GDM management.

Project description:BackgroundCardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM) are posing a huge burden on health care systems worldwide. Mobile apps can deliver behavior change interventions for chronic disease prevention on a large scale, but current evidence for their effectiveness is limited.ObjectiveThis paper reported on the development and user testing of a mobile app that aims at increasing risk awareness and engaging users in behavior change. It would form part of an intervention for primary prevention of CVD and T2DM.MethodsThe theoretical framework of the app design was based on the Behaviour Change Wheel, combined with the capability, opportunity, and motivation for behavior change system and the behavior change techniques from the Behavior Change Technique Taxonomy (version 1). In addition, evidence from scientific literature has guided the development process. The prototype was tested for user-friendliness via an iterative approach. We conducted semistructured interviews with individuals in the target populations, which included the System Usability Scale. We transcribed and analyzed the interviews using descriptive statistics for the System Usability Scale and thematic analysis to identify app features that improved utility and usability.ResultsThe target population was Australians aged ≥45 years. The app included 4 core modules (risk score, goal setting, health measures, and education). In these modules, users learned about their risk for CVD and T2DM; set goals for smoking, alcohol consumption, diet, and physical activity; and tracked them. In total, we included 12 behavior change techniques. We conducted 2 rounds of usability testing, each involving 5 participants. The average age of the participants was 58 (SD 8) years. Totally, 60% (6/10) of the participants owned iPhone Operating System phones, and 40% (4/10) of them owned Android phones. In the first round, we identified a technical issue that prevented 30% (3/10) of the participants from completing the registration process. Among the 70% (7/10) of participants who were able to complete the registration process, 71% (5/7) rated the app above average, based on the System Usability Scale. During the interviews, we identified some issues related to functionality, content, and language and clarity. We used the participants' feedback to improve these aspects.ConclusionsWe developed the app using behavior change theory and scientific evidence. The user testing allowed us to identify and remove technical errors and integrate additional functions into the app, which the participants had requested. Next, we will evaluate the feasibility of the revised version of the app developed through this design process and usability testing.

Project description:BackgroundGestational diabetes (GDM) is a known risk factor for type 2 diabetes mellitus (T2DM), and women with a history of GDM have a 7-fold increased risk of developing the disease. Achieving a healthy weight post-delivery is key in reducing the risk of future diabetes in these women. The aim of this trial is to investigate the use of an interactive smartphone application (APP) to restore women to optimal weight following delivery.MethodsThis will be an open-label randomized controlled trial. Two hundred women with gestational diabetes will be randomized to receive the intervention or standard care following delivery. Participants will be reviewed at 6 weeks and 4 months post-delivery. The intervention is an APP serving as a platform for weight, diet and physical activity tracking. The APP provides 3-5 min educational videos suggesting suitable lifestyle adjustments relevant to postnatal period such as breast feeding, diet and exercise. Lastly, the APP will allow real-time interaction between users and the team of dietitians, physiotherapists and occupational therapists to encourage restoration of optimal weight. Women in the control arm will be informed about the increased risk of developing T2DM and advised to maintain a healthy weight. Primary outcome measure is the restoration of participants' booking weight if booking BMI ≤ 23, or weight loss of at least 5% from booking weight if booking BMI > 23 over the 4 month period. Secondary outcome measures will assess serum metabolic and inflammatory markers, quality of life via questionnaires and cost-effectiveness of the intervention at each follow-up visit.DiscussionThis will be the first randomised controlled trial investigating the use of a smartphone application for postpartum weight loss in women with gestational diabetes. The major ethnic groups in our study population represent the majority of ethnic groups in Asia, amongst which the prevalence of diabetes is high. If shown to be effective, this APP may be used in wider clinical settings to improve postpartum weight loss and reduce the risk of developing T2DM in these women.Trial registrationThis study was registered on clintrials.gov on the 30th of October 2017, under the trial registration number: NCT03324737 .

Project description:BackgroundGestational diabetes mellitus (GDM) is the most common complication during pregnancy and is associated with an increased risk for the development of cardiometabolic diseases. Behavioral interventions can reduce this risk, but current solutions insufficiently address the requirements for such a program. The systematic development of a scalable mobile health (mHealth) promotion program for mothers during the first years post-GDM may contribute to solving this problem.ObjectiveThe aim of this project was to systematically plan and develop a theory- and evidence-based mHealth intervention to change cardiometabolic risk behaviors in women during the first 5 years post-GDM that meets women's expected standards of commercial health apps.MethodsThe intervention mapping steps 1 to 4 structured the systematic planning and development of the mHealth program described in this paper. Steps 1 and 2 led to a theory- and evidence-based logic model of change for cardiometabolic health. Based on this model, the prevention program was designed (step 3) and produced (step 4) in cooperation with industrial partners to ensure a high technological standard of the resulting smartphone app for the iPhone (Apple Inc). Step 4 included a user study with women during the first 5 years post-GDM once a beta version of the app ("TRIANGLE") was available. The user study comprised 2 test rounds of 1 week (n=5) and 4 weeks (n=6), respectively. The tests included validated questionnaires on user acceptance, user logs, and think-alouds with semistructured interviews.ResultsThe novel TRIANGLE app is among the first self-paced smartphone apps for individual habit change in the 3 lifestyle areas of physical activity, nutrition, and psychosocial well-being. The 3 core features-a challenge system, human coaching, and a library-address 11 behavioral determinants with 39 behavior change methods to support lifestyle changes. Participants in the user study showed a high acceptance, high perceived quality, and high perceived impact of the TRIANGLE app on their health behaviors. Participants tested the app regularly, used it intuitively, and suggested improvements. We then adapted the TRIANGLE app according to the insights from the user study before the full TRIANGLE program production.ConclusionsThe intervention mapping approach was feasible to plan and develop an innovative and scalable smartphone solution for women during the first 5 years post-GDM. The resulting TRIANGLE intervention has the potential to support behavior change for cardiometabolic disease prevention. However, the app needs further refinement and testing in clinical trials. Intervention mapping steps 5 (implementation plan) and 6 (evaluation plan) may support the integration of the TRIANGLE intervention into routine care.Trial registrationGerman Clinical Trials Register DRKS00012736; https://www.drks.de/DRKS00012736.

Project description:BackgroundWomen with a history of gestational diabetes mellitus (GDM) are at an increased risk of developing type 2 diabetes mellitus (T2DM). Lifestyle interventions aimed at postpartum weight loss to reduce T2DM risk have been reported, but poor compliance remains a barrier. Smartphone-based interventions may improve compliance, but data on its use in women with recent GDM are limited.ObjectiveThis trial aimed to investigate the efficacy of a smartphone app in restoring optimal weight following delivery in women with GDM, in the setting of a population with high rates of GDM and type 2 diabetes.MethodsIn this unblinded randomized controlled trial, 200 women with GDM were randomized to receive the intervention or standard care following delivery. The intervention enabled logging of weight, meals, and activity, with web-based interaction with a team comprising dieticians, a physiotherapist, and an occupational therapist. The primary outcome was an achievement of optimal weight (defined as the restoration of first trimester weight if first trimester BMI≤23 kg/m2 or weight loss of at least 5% from first trimester weight if first trimester BMI>23 kg/m2) at 4 months post partum. Secondary outcome measures included absolute weight loss, serum metabolic markers, self-reported nutritional intake, health education, and quality of life via questionnaires and user engagement in the intervention group.ResultsIn total, 40% (38/96) of women in the intervention group achieved optimal weight at 4 months post delivery compared with 32% (28/93) in the control group (P=.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (P<.001) and higher health-directed behavior scores (P=.045). The intervention group also reported increased emotional distress scores (P=.01). At 4 months, participant engagement with the intervention was maintained at 60.8% (SD 33.9%).ConclusionsAlthough a statistically significant increase in women achieving healthy weight was not observed, this app remains promising, as women in the intervention group reported improved health behaviors and lower caloric intake. Importantly, the high retention rates suggest that a larger study with a longer follow-up period might confirm the effectiveness of this app for weight management.Trial registrationClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737.International registered report identifier (irrid)RR2-10.1186/s12889-019-7691-3.

Dataset Information

A Mobile Phone App for the Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus: Protocol for a Feasibility Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

A Mobile Phone App for the Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus: Protocol for a Feasibility Randomized Controlled Trial.

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