Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes

Abstract

Background Gestational 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. Methods This 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. Discussion This 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 registration This study was registered on clintrials.gov on the 30th of October 2017, under the trial registration number: NCT03324737.

A Smartphone App (TRIANGLE) to Change Cardiometabolic Risk Behaviors in Women Following Gestational Diabetes Mellitus: Intervention Mapping Approach

“…The goal of this project was to plan and develop one of the first smartphone app-based interventions to change cardiometabolic risk behaviors in women during the first 5 years post-GDM [14,28,92,94]. The resulting TRIANGLE intervention confirmed the value of using the systematic intervention mapping framework to plan a complex health promotion program [95].…”

“…We identified 2 main subgroups: women who were overweight with a BMI ≥23 kg/m 2 and women with a BMI <23 kg/m 2 . We chose the threshold of BMI ≥23 kg/m 2 previously applied to Asian populations [28] instead of the traditional threshold of BMI ≥25 kg/m 2 [29] to define overweight since the women in the target group were younger [30] than traditional at-risk cohorts [29,31]. Therefore, 2 .…”

“…In contrast to the flexible pacing desired by women in the first 2 years post-GDM [11], most other programs followed fixed sequences such as the DPP curriculum [89,102]. Current programs are testing different features for smartphone-based interventions in the first year post-GDM, varying degrees of automation, and cross-links to other platforms and thus will soon provide further insights [14,28,94].…”

“…The desire of single participants for new features will have to be quantified before changing the TRIANGLE app system. Some of these desired features for apps in the first year post-GDM are currently being tested by other work groups, such as a built-in pedometer to translate other types of physical activity into step counts [28].…”

Interventions to support women with overweight or obesity or gestational diabetes mellitus to initiate and continue breastfeeding: Systematic review and meta‐analysis

“…A total of 2,740 participants were included, which included 226 dyads from one study. 26 The majority of studies were conducted in high income countries: Australia (n = 2), 30,37 Canada (n = 1), 31 Columbia (n = 1), 38 Denmark (n = 3), 26,36,41 Norway (n = 1), 25 Singapore (n = 1), 40 USA (n = 8), [27][28][29][32][33][34]39 and UK (n = 1), 42 and a single study was conducted in a lower-middle income country, Egypt. 35 Sample size varied from 36 to 360 (Mean = 167).…”