Background: Women 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. Objective: This 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. Methods: In 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. Results: In 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%). Conclusions: Although 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 Registration: ClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-019-7691-3

Mobile and tablet apps, ubiquitous and pervasive computing, wearable computing and domotics for health.

BACKGROUND Women 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. OBJECTIVE This 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. METHODS In 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. RESULTS In 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%). CONCLUSIONS Although 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. CLINICALTRIAL ClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-019-7691-3

BACKGROUND Mobile apps are becoming an increasingly ubiquitous platform for delivery of health behavior interventions among overweight and obese perinatal women. However, only a few methodological guidelines on integrating theory, evidence, and qualitative research for their designs are available. OBJECTIVE The aim of this study was to develop a theory-based, evidence-driven, and user-centered healthy lifestyle app targeting overweight and obese multiethnic pregnant women. METHODS This paper illustrates how intervention development may be enriched with theoretical basis, systematic review, and qualitative study. An individual face-to-face interview was performed to incorporate the user’s involvement in the design. These interviews were audiotaped and transcribed. Thematic analysis technique was used for emerging themes. RESULTS Integrated concepts of social cognitive theory of self-regulation, self-regulation model, and strength model of self-control were selected as bases of the intervention. Evidence from our systematic review and meta-analysis provided the strongest evidence for the development of intervention. We invited 16 obese or overweight pregnant women to participate in a semistructured interview . The following key themes emerged: content, platform, interactivity, format, and functionality. Apps are a favorable technology platform for healthy diet advice, appropriate physical exercise, and weight management because they are user-friendly and convenient. The app used in this study contains culture-specific, pregnancy-related, and credible contents, including educational, professional and peer support, and self-monitoring domains. The design should include aesthetic appeal, visualized features, and interactive multimedia. CONCLUSIONS A 3-step process integrating theoretical basis, evidence from systematic review, and research findings from target users can be considered a guide for future app development.