Leveraging game-based mobile app to limit excessive weight gain and retention among pregnant women with overweight and obesity - PROJECT SUMMARY Gestational weight gain (GWG) has important implications for maternal and child health and is an ideal modifiable factor to improve short- and long-term health outcomes among women and children. Here we propose to develop and test a game-based mobile app (GWG-DH) to prevent excessive gestational weight gain (GWG) and limit postpartum weight retention (PPWR) among women in Nepal who enter pregnancy with overweight and obesity (BMI≥25 kg/m2 ). In the R21 phase, we will apply a user-centered agile design approach to adapt our existing app GDM-DH (developed to support diet/lifestyle modification in Nepalese pregnant women with gestational diabetes) and expand and refine it to make a game-based weight management app (GWG-DH) that matches the needs and technological sophistication of our target users (Nepalese pregnant women with overweight and obesity). The R33 phase will employ a Type I Hybrid Implementation Science Framework to test the efficacy of the GWG-DH intervention against standard care via a randomized control trial (RCT), while also evaluating its potential for implementation in real-world settings. In Year 1, we will select content modules and features for the GWG-DH app based on evidence review, theory-based behavioral change techniques, and expert discussions. Next, we will conduct design workshops with 18 target users to customize the features and game elements to match user preferences and ensure cultural relevance. Following this, we will create the app’s prototype and conduct interviews with 5 health providers and conduct 3 rounds of focus groups with target users (n=18), asking them to view the app prototype and provide feedback on its features, functions, and content. In Year 2, the revised GWG-DH app will undergo usability testing (n=27), followed by the full development of the app (beta version), and 3-month Beta testing (n=27) to assess its functionality, usability, and acceptability. With iterative refinements of the beta versions, we will build the final ready-to-test version of the GWG-DH for evaluation in the R33 phase (Years 3-5). For the RCT, we will recruit 360 pregnant women with pre-pregnancy BMI≥25 kg/m2 and randomly assign them into either (A) standard care, or (B) GWG-DH app + standard care, with up to 1 year of intervention, from 16±2 gestational weeks to 6 months postpartum. Potential mediators will be assessed at 34±3 gestational weeks and 3 months postpartum. Primary (weight) and secondary (diet/lifestyle) outcomes will be assessed at 34±3 gestational weeks, delivery and at 6 months postpartum. We hypothesize that compared to standard care, the use of GWG-DH app in addition to standard care will result in a lower rate of excessive GWG, lower PPWR, better diet quality, and greater level of physical activity during pregnancy and postpartum. Concurrent with the RCT, we will conduct a mixedmethods implementation and evaluation of the GWH-DH app, following the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. Findings from this study will support the dissemination and scaling of evidence-based GWG interventions across various settings, including low-resource areas in the U.S. and maternity care deserts, where access to maternal health services is limited.
