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

February 7, 2024 updated by: Andrea Shields, UConn Health

Meals 4 Moms: Development and Feasibility of a Multilevel Community-based Lifestyle Intervention for Gestational Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gestational diabetes mellitus, or GDM, affects many pregnancies throughout the United States contributing to an increased risk of negative pregnancy outcomes such as delivery complications, hospitalizations, and poor clinical outcomes for both patients and infants. Additionally, many pregnant patients with GDM will progress to developing Type 2 diabetes within their lifetime. GDM, therefore, is the perfect window of opportunity for the prevention of diabetes.

GDM management requires education and adoption of a specific diet, daily blood sugar monitoring, exercise, and compliance with prenatal visits. Adopting all these changes may be hard to understand and comply with in a short window of time as, on average, patients are diagnosed GDM 8 to 10 before delivery. Thus, to achieve these goals quickly, patients must have immediate access to nutrient-rich food, and on-going education and support regarding healthy-meal preparation, including portion sizes, frequency, and composition of healthy snacking.

Previous and on-going research on health food prescription programs and supervised exercise sessions are often not performed with patients with GDM. To address this gap, investigators aim to develop a lifestyle intervention that promotes self-efficacy with unsupervised exercise and evidence-based behavioral strategies (e.g. goal setting, monitoring and feedback) and incorporate the use of physical activity tracking devices to support these strategies. This project has two distinct phases. First, to develop the novel Meals for Moms (M4M) community-based lifestyle intervention using feedback and input from women living with GDM. Second, to conduct a pilot feasibility randomized trial comparing the feasibility, compliance, and acceptability of the M4M intervention versus the usual care for pregnant persons diagnosed with GDM.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • UConn Health
        • Principal Investigator:
          • Andrea Shields, MD, MS
        • Contact:
        • Contact:
          • Kristen Annis-Brayne, RN
          • Phone Number: 8606793360
          • Email: annis@uchc.edu
        • Sub-Investigator:
          • Zhao (Helen) Wu, PhD
        • Sub-Investigator:
          • Ock Chun, PhD, MPH
        • Sub-Investigator:
          • Molly Waring, PhD
        • Sub-Investigator:
          • Linda Pescatello, PhD
        • Sub-Investigator:
          • Christopher Nold, MD
        • Sub-Investigator:
          • MaryBeth Janicki, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-49 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual GDM Care
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.
Experimental: Meals 4 Moms intervention

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability (participate again)
Time Frame: Follow-Up (within 2 weeks post-delivery)
Percent of participants who report they would be likely or very likely to participate again if they had gestational diabetes (GDM) again.
Follow-Up (within 2 weeks post-delivery)
Acceptability (recommended)
Time Frame: Follow-Up (within 2 weeks post-delivery)
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 (within 2 weeks post-delivery)
Recruitment
Time Frame: Baseline
Recruitment rates will be calculated from the number of patients approached and reasons for ineligibility and non-participation.
Baseline
Retention
Time Frame: Follow-Up (within 2 weeks post-delivery)
Proportion of participants who complete any aspect of the follow-up assessment.
Follow-Up (within 2 weeks post-delivery)
Receipt of intervention (Meal Ordering)
Time Frame: Follow-Up (within 2 weeks post-delivery)
Percent of participants who spent at least 80% of weekly $260 food budget.
Follow-Up (within 2 weeks post-delivery)
Receipt of intervention (Exercise Session Completion)
Time Frame: Follow-Up (within 2 weeks post-delivery)
Percent of participants who completed at least 80% of exercise sessions they were eligible to complete.
Follow-Up (within 2 weeks post-delivery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

University of Connecticut
Hartford Hospital
Trinity Health Of New England

Investigators

  • Principal Investigator: Andrea Shields, MD, MS, UConn Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-190SSF-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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