Meals 4 Moms: A Multilevel Community-based Lifestyle Intervention for GDM

NCT06227247 | Terminated Results

• 1 other identifier: 23-190SSF-2
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the project is to conduct a pilot feasibility randomized trial comparing a community-based lifestyle intervention called Meals for Moms (M4M) versus the usual care for pregnant persons diagnosed with gestational diabetes (GDM). Participants will be randomly placed into the usual care (UC) comparison group or the M4M healthy living program, which includes continued GDM education, physical activity level monitoring, and delivery of medically-tailored GDM meals. The trial will assess if M4M is feasible for the management of gestational diabetes in pregnant patients.

Conditions

Gestational Diabetes

Keywords

Diabetes; Gestational diabetes; Pregnancy; Exercise; Nutrition; Diabetes education

Outcome Measures

Primary Outcomes (6)

• Acceptability (Participate Again)

  Percent of participants who report they would be likely or very likely to participate again if they had gestational diabetes (GDM) again.

  Follow-Up (aim: within 2 weeks post-delivery)

• Acceptability (Recommended)

  Percent of participants who report they would be likely to very likely to recommend the M4M intervention to a friend with gestational diabetes (GDM).

  Follow-Up (aim: within 2 weeks post-delivery)

• Recruitment

  Recruitment rates will be calculated from the number of patients approached and reasons for ineligibility and non-participation.

  Baseline

• Retention

  Percent of participants who complete any aspect of the follow-up assessment.

  Follow-Up (aim: within 2 weeks post-delivery)

• Receipt of Intervention (Meal Ordering)

  Percent of participants who spent at least 80% of weekly $266 food budget.

  Follow-Up (aim: within 2 weeks post-delivery)

• Receipt of Intervention (Exercise Session Completion)

  Percent of participants who completed at least 80% of exercise sessions they were eligible to complete.

  Follow-Up (aim: within 2 weeks post-delivery)

Study Arms (2)

Meals 4 Moms intervention

EXPERIMENTAL

Participants randomized to the M4M condition will receive: * Food budget of $266 per week in credits to spend towards medically-tailored GDM meals * Enhanced educational GDM-specific education on exercise, nutrition, and blood sugar glucose management * Activity tracker and digital scale * Usual GDM care

Behavioral: Meals4Moms Intervention

Usual GDM Care

NO INTERVENTION

Usual care (UC) will consist of the current treatment care that is provided by the participant's prenatal care provider. Usual care consists of a special diet, monitoring of blood glucose levels and encouragement/guidance of increasing a participant's exercise.

Interventions

Meals4Moms Intervention BEHAVIORAL

A community-based, healthy living program including continued gestational diabetes (GDM) education, physical activity level monitoring, and delivery of medically-tailored GDM meals for the management of gestational diabetes in pregnant people.

Meals 4 Moms intervention

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Current singleton pregnancy
• GDM diagnosis between 24+0 and 31+6 weeks gestation, and no more than 4weeks from time of diagnosis at time of enrollment.
• Currently receiving gestational diabetes management at the UConn Health Maternal Fetal Clinic, St. Francis's Hospital Women's Health clinic, Hartford Healthcare Women's Ambulatory Health Services (WAHS)
• Intends to deliver at either UConn Health, St. Francis Hospital or Hartford Healthcare
• Able to read and understand English well enough to participate in the study in English
• Daily access to the internet from smartphone, tablet computer, or laptop/desktop computer that they can use to participate in the study
• Medical clearance to participate from prenatal care provider including clearance to engage in physical activity
• Able to provide verbal or written consent for each component of the study procedures and data collection
• Currently lives within one of the meal delivery areas in Connecticut to allow for meal delivery (total of 32 eligible towns/cities)

You may not qualify if:

• Unable or unwilling to give informed consent or communicate with study staff.
• Diabetes mellitus (Type I or Type II).
• GDM diagnosed prior to 24 weeks gestation or after 32+0 weeks gestation.
• Patient is scheduled for a preterm delivery for medical reasons (i.e., placenta accreta, prior classical incision) at time of eligibility screening or at any time prior to randomization.
• Concurrent participation in another research study providing intervention related to GDM, pregnancy, diet, and/or physical activity.
• Medical conditions that may result in the inability to tolerate solid foods (i.e., hyperemesis gravidarum).
• Medical condition which would prohibit participation as indicated by prenatal care provider providing medical clearance.
• Dietary restrictions that cannot be accommodated for during meal preparation.
• Currently does not live in one of the towns listed within the meal delivery area.
• Has plans to move to out of the meal delivery area between enrollment and expected pregnancy due date.

Sponsors & Collaborators

• Trinity Health Of New England: collaborator
• Hartford Hospital: collaborator
• UConn Health: lead
• University of Connecticut: collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

Related Publications (20)

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Related Links

• Centers for Disease Control. Gestational Diabetes.
• A Subsidized Healthy Food Prescription Program for Adults With Type 2 Diabetes Who Are Experiencing Food Insecurity: Protocol for a Randomized Controlled Trial (PMCID: PMC8265448)

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Results Point of Contact

• Title: Dr. Molly Waring (study statistician)
• Organization: University of Connecticut

molly.waring@uconn.edu

860-486-1446

Study Officials

• Andrea Shields, MD, MS

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: We plan to randomize 40 participants 1:1 to the M4M intervention vs usual GDM care (UC)

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: March 5, 2024
• Primary Completion: December 16, 2024
• Study Completion: January 7, 2025
• Last Updated: May 5, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)