A Randomized Controlled Trial of Prepared vs. Unprepared Food
NCT07800182 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-09-02
Summary
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.
Conditions
- Pregnant Patients at Risk of Gestational Diabetes
Interventions
- BEHAVIORAL
-
Prepared meals
The box is prepared meals and includes ready-to-heat meals from a diabetes-friendly menu, with some participant selection of meals after initial deliveries.
- BEHAVIORAL
-
Unprepared Pantry/Produce box
The 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.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Alex Peahl · University of Michigan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2027-07-31
- Completion
- 2027-07-31
Countries
- United States
Study Locations
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