A Randomized Controlled Trial of Prepared vs. Unprepared Food

N/ANot Yet RecruitingNCT07800182

University of Michigan40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pregnant Patients at Risk of Gestational Diabetes

Interventions

Prepared mealsBEHAVIORAL

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 boxBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Feasibility of the food delivery intervention- recruitment

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.

Time frame: 6 months (26 weeks)

Feasibility of the food delivery intervention - retention

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.

Time frame: Approximately 3 months (12 weeks)

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

Effectiveness is defined as the percent of successful deliveries.

Time frame: Approximately 3 months (12 weeks)

Acceptability of the food delivery intervention for pregnant patients

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

Time frame: Approximately 4 months (16 weeks)

Central Contacts

Caitlyn Clock, MPH

CONTACT

734-998-6485 cclock@med.umich.edu

Alex Peahl, MD, MSc

CONTACT

alexfrie@med.umich.edu

Data from ClinicalTrials.gov

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