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NCT Number: NCT07800182

A Randomized Controlled Trial of Prepared vs. Unprepared Food

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.

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Key information

Conditions

Pregnant Patients at Risk of Gestational Diabetes Body Weight Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location contact

Alex Peahl, MD

PRINCIPAL_INVESTIGATOR

Caitlyn Clock, MPH

CONTACT

[email protected]

(734) 998-6485

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Prepared meals

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

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.

Primary outcomes

  1. Feasibility of the food delivery intervention- recruitment

    Time frame: 6 months (26 weeks)

    Feasibility will be assessed by individual recruitment of individuals into the study. Measure: Feasibility will be assessed by the number of participants recruited in 6 months. Success: recruitment of 40 participants.

  2. Feasibility of the food delivery intervention - retention

    Time frame: Approximately 3 months (12 weeks)

    Feasibility will be assessed by retention of individuals in the study. Measure: the number of participants engaged at 12 weeks post enrollment. Success: 60% indicating success.

  3. Preliminary effectiveness of the food delivery intervention to improve access to healthy foods

    Time frame: Approximately 3 months (12 weeks)

    Effectiveness is defined as the percent of successful deliveries.

  4. Acceptability of the food delivery intervention for pregnant patients

    Time frame: Approximately 4 months (16 weeks)

    Measured from self-report. Acceptability will be measured by percent of participants' positive responses on the Acceptability of Implementation Measure.

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Peahl, MD, MSc

CONTACT

[email protected]

Caitlyn Clock, MPH

CONTACT

[email protected]

734-998-6485

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Prepared for Pregnancy: A Randomized Controlled Trial of Prepared vs. Unprepared Food

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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