What this study is
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.
What's being tested
- Prepared meals
Intervention · BEHAVIORAL
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.
- Unprepared Pantry/Produce box
Intervention · BEHAVIORAL
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.
Study details
- Official title
- Prepared for Pregnancy: A Randomized Controlled Trial of Prepared vs. Unprepared Food
- Sponsor
- University of Michigan
- Conditions
- Pregnant Patients at Risk of Gestational Diabetes
- Enrolling
- 40 people
- Starts
- 2026-09
- Est. completion
- 2027-07
- Design
- Open-label, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Currently pregnant at <24 weeks gestational age
- English-speaking
- Lives in Wayne County
- Engaged in Meridian-Case Management Program
- At least one risk factor for GDM as defined by ACOG OR diagnosis of Type 1/2 Diabetes:; Overweight, obese, limited physical activity; Previous pregnancy with gestational diabetes; Prior baby with macrosomia in a past pregnancy ▪ A very large baby in a previous birth (also known as macrosomia). This would be a baby bigger than 9 lbs 15 oz for diabetes or 11 lbs without diabetes.; Hypertension, heart disease; PCOS (polycystic ovarian syndrome); Prediabetes; First degree relative with diabetes; Member of a racial or ethnic group with a higher prevalence of diabetes (e.g., Black, Native American or Alaska Native, Asian, Hispanic/Latino or Pacific Islander
You can't join if
- Unable to converse in English
- Not meeting the above criteria
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Michigan
Ann Arbor, Michigan, United States
- Caitlyn Clock, MPH · Contact(734) 998-6485cclock@med.umich.edu
- Alex Peahl, MD · Principal investigator
Study team
Sponsor
University of Michigan
Study ID HUM00295794
Principal investigator
Alex Peahl
University of Michigan
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.