Lifestyle support and meals to prevent diabetes after gestational diabetes
Tests lifestyle support with or without meals after gestational diabetes pregnancy, delivered through home visits.
Key facts
- Who runs it
- California Polytechnic State University-San Luis Obispo
- Where
- Chicago, Providence, and San Luis Obispo, United StatesSee the 3 sites
- Trial code
- Registry title
- Lifestyle Interventions to Prevent Diabetes in U.S. Home Visiting Programs
- Status
- Recruiting
- People taking part
- 978 people, planned
- Started
- 15 Jan 2026
- Expected to end
- 30 Apr 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- GDM Enhanced
- Meals
- Record updated
- 5 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adult women in a home visiting program who had gestational diabetes (diabetes during pregnancy) in their most recent pregnancy. They must be pregnant now or have given birth less than 3 months ago.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Gestational diabetes in the most recent pregnancy, based on what the person reports. Pregnant now, or less than 3 months (13 weeks) after giving birth.
- Earlier treatment
- People cannot already be getting medically tailored meals.
Main reasons for not taking part
- Diabetes that started before the pregnancy, based on what the person reports
- Not currently in a home visiting program
- Not speaking English or Spanish
- Not willing to be put by chance into either group
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Pre-existing diabetes (based on self-report)
Where in United States
- Northwestern UniversityChicago, United StatesContact: Darius Tandon, PhDNot yet recruiting
- Miriam HospitalProvidence, United StatesContact: Rena R Wing, PhDNot yet recruiting
- California Polytechnic State UniversitySan Luis Obispo, United StatesContact: Suzanne Phelan, PhDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Usual Home Visiting plus GDM EnhancedExisting treatment, for comparison
This group receives usual home visitation plus GDM Enhanced intervention.
Treatment: GDM Enhanced
- Usual HV + GDM Enhanced + MealsTreatment being tested
This group will receive usual home visitation plus GDM Enhanced plus medically tailored meals.
Treatment: GDM Enhanced and Meals
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Controlled Trial of Lifestyle Interventions for the Prevention of Diabetes in US Home Visiting Programs
- Plain-language title
- Lifestyle support and meals to prevent diabetes after gestational diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 5 March 2026