A Randomized Controlled Trial of Prepared vs. Unprepared Food
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan
- Study ID
- NCT07800182
- Status
- Not Yet Recruiting
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Conditions
- Pregnant Patients at Risk of Gestational Diabetes
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Prepared meals — BEHAVIORALThe box is prepared meals and includes ready-to-heat meals from a diabetes-friendly menu, with some participant selection of meals after initial deliveries.
- Unprepared Pantry/Produce box — BEHAVIORALThe produce boxes include about 12 pounds of fresh fruits and vegetables. The pantry boxes include shelf-stable foods, and an allergen-friendly pantry box is available if needed. Unprepared food boxes will also include ideas for recipes using some of the items in the box.
Study Details
The goal of this study is to assess the feasibility of different food interventions, delivered through insurance providers, for addressing food insecurity in patients at risk of gestational diabetes (diabetes in pregnancy). Interventions include prepared food (fully prepared meals that participants can heat and eat) and unprepared food (boxes containing both fresh and shelf-stable items). The study will also assess the acceptability of food interventions for pregnant people.
Key Dates
- First listed
- Sep 2, 2026
- Start date
- Sep 30, 2026
- Status verified
- Aug 2026
- Primary completion
- Jul 31, 2027
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- OTHER
Arms
- Experimental: Group A: Prepared Meals firstPrepared meals (weeks 1-4), Unprepared Pantry/Produce boxes (weeks 5-12)
- Experimental: Group B: Unprepared Pantry/Produce boxes firstUnprepared Pantry/Produce boxes (weeks 1-8), Prepared meals (weeks 9-12)
Primary Outcome Measure
Feasibility of the food delivery intervention- recruitment [ Time Frame: 6 months (26 weeks) ]
Central Contacts
- Caitlyn Clock, MPH734-998-6485
- Alex Peahl, MD, MSc
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | Alex Peahl, MD (PRINCIPAL_INVESTIGATOR) |