TERMINATED

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

Conditions

Gestational Diabetes Diabetes Pregnancy Exercise Nutrition Diabetes education

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-05

Study Completion:2025-01-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06227247

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.

Ages Eligible for Study:18 Years to 49 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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)	* 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.

Inclusion Criteria

Exclusion 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)

* 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.

Contacts and Locations

Principal Investigator

Andrea Shields, MD, MS

PRINCIPAL_INVESTIGATOR

UConn Health

Study Locations (Sites)

UConn Health

Farmington, Connecticut, 06030

United States

Collaborators and Investigators

Sponsor: UConn Health

Andrea Shields, MD, MS, PRINCIPAL_INVESTIGATOR, UConn Health

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 Registration Dates

Study Start Date2024-03-05

Study Completion Date2025-01-07

Study Record Updates

Study Start Date2024-03-05

Study Completion Date2025-01-07

Terms related to this study

Keywords Provided by Researchers

Diabetes
Gestational diabetes
Pregnancy
Exercise
Nutrition
Diabetes education

Additional Relevant MeSH Terms

Gestational Diabetes