Randomized Controlled Trial of Lifestyle Interventions for the Prevention of Diabetes in US Home Visiting Programs
California Polytechnic State University-San Luis Obispo
Summary
The study is examining the health effects of gestational diabetes mellitus (GDM) intervention and medically tailored meals within home visiting. A large study is proposed that will include nearly a thousand pregnant or recently pregnant adults with recent GDM and who are from different regions and backgrounds. Two treatment approaches are compared, and both are in home visiting. One treatment group is receiving enhanced lifestyle support for GDM along with meals, and the other is receiving just the enhanced lifestyle support. The study will examine whether these interventions help reduce diabetes and pre-diabetes through 12 months postpartum, as well as other health factors like weight and blood pressure.
Description
Gestational diabetes mellitus (GDM) is rapidly rising in prevalence and has been linked with several short and long-term adverse maternal health outcomes, including type 2 diabetes (T2DM) and cardiovascular disease. The postpartum year is a time of heightened risk, and 32-46% of people with GDM develop type 2 diabetes (T2DM) or Pre-Diabetes (PreDM) during the postpartum year. To prevent maternal diabetes, US guidelines recommend behavioral counseling to promote healthy eating, activity, and weight, but dissemination channels have been lacking. Evidence-based home visiting programs, with their…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Currently in home visiting * Pregnant or \< 3 months (13 weeks) postpartum * Gestational Diabetes Mellitus diagnosis in most recent pregnancy (based on self-report) * Aged 18 years or older * English- or Spanish-speaking. * Not currently being given medically tailored meals * Willing to receive randomization to either group Exclusion Criteria: • Pre-existing diabetes (based on self-report)
Interventions
- BehavioralGDM Enhanced
The GDM Enhanced intervention is comprised of HV-delivered, evidence-based modules (10-20 minutes) with facilitator guides. The content prioritizes management and prevention of diabetes through healthy eating, physical activity, and stigma-informed weight management strategies.
- BehavioralMeals
The Meal intervention includes medically tailored meals being provided to participants starting after randomization and tailored to their individual dietary preferences and cultural considerations.
Locations (3)
- California Polytechnic State UniversitySan Luis Obispo, California
- Northwestern UniversityChicago, Illinois
- Miriam HospitalProvidence, Rhode Island