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Testing prepared meals versus food boxes for pregnant people at risk of gestational diabetes

Compares ready-made meals with unprepared food boxes in pregnant people facing food insecurity.

Key facts

Who runs it
University of Michigan
Where
Ann Arbor, United StatesSee the site
Trial code
Registry title
A Randomized Controlled Trial of Prepared vs. Unprepared Food
Status
Not yet recruiting
People taking part
40 people, planned
Starts
Mar 2027
Expected to end
Jul 2027
Type of study
Interventional, 2 groups
Treatments tested
  • Prepared meals
  • Unprepared Pantry/Produce box
Record updated
12 November 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 pregnant women under 24 weeks of pregnancy who are at risk of gestational diabetes. They must live in Wayne County and be in the Meridian-Case Management Program.

Age
18 years or older
Sex
Women only
Disease stage
Pregnant at less than 24 weeks. At least one risk factor for gestational diabetes, or a diagnosis of Type 1 or Type 2 diabetes.

Main reasons for not taking part

  • Cannot speak English
  • Does not live in Wayne County
  • Not engaged in the Meridian-Case Management Program
  • Pregnant for 24 weeks or more

This trial only enrols pregnant participants. The registry sentence this rests on: Currently pregnant at <24 weeks gestational age

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Unable to converse in English
  • Not meeting the above criteria

Where in United States

  • University of MichiganAnn Arbor, United StatesContact: Caitlyn Clock, MPHNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Group A: Prepared Meals firstTreatment being tested

    Prepared meals (weeks 1-4), Unprepared Pantry/Produce boxes (weeks 5-12)

    Treatment: Prepared meals and Unprepared Pantry/Produce box

  • Group B: Unprepared Pantry/Produce boxes firstTreatment being tested

    Unprepared Pantry/Produce boxes (weeks 1-8), Prepared meals (weeks 9-12)

    Treatment: Prepared meals and Unprepared Pantry/Produce box

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prepared for Pregnancy: A Randomized Controlled Trial of Prepared vs. Unprepared Food
Plain-language title
Testing prepared meals versus food boxes for pregnant people at risk of 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 12 November 2026.
Record updated
12 November 2026