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Behavioral Intervention

Meals 4 Moms intervention for Gestational Diabetes

N/A

Recruiting

Led By Andrea Shields, MD, MS

Research Sponsored by UConn Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18-49 years old

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow-up (within 2 weeks post-delivery)

Awards & highlights

Study Summary

This trial aims to compare a community-based lifestyle program called Meals for Moms (M4M) with standard care for pregnant individuals with gestational diabetes. Participants will be randomly assigned to either the standard care

Who is the study for?

This trial is for pregnant individuals diagnosed with gestational diabetes. It's designed to see if a special program called Meals for Moms (M4M), which includes education, activity monitoring, and tailored meals, can help manage their condition better than the usual care.Check my eligibility

What is being tested?

The study tests the Meals for Moms (M4M) intervention against standard treatment. M4M provides extra support through ongoing diabetes education, tracking physical activity levels, and delivering meals specifically designed for gestational diabetes management.See study design

What are the potential side effects?

Since this trial involves lifestyle changes rather than medication, side effects may include discomfort from dietary adjustments or increased physical activity but are generally expected to be minimal compared to drug interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 49 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow-up (within 2 weeks post-delivery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow-up (within 2 weeks post-delivery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up (within 2 weeks post-delivery) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability (participate again)

Acceptability (recommended)

Receipt of intervention (Exercise Session Completion)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Meals 4 Moms interventionExperimental Treatment1 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

Group II: Usual GDM CareActive Control1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

UConn HealthLead Sponsor

211 Previous Clinical Trials

60,581 Total Patients Enrolled

Hartford HospitalOTHER

133 Previous Clinical Trials

18,892 Total Patients Enrolled

University of ConnecticutOTHER

184 Previous Clinical Trials

158,253 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this medical study currently accepting new participants?

"Indeed, as per the details available on clinicaltrials.gov, this current clinical trial is actively seeking eligible participants. The trial was initially posted for recruitment on February 1st, 2024 and underwent its last update on January 17th, 2024."

Answered by AI

Could individuals aged 60 and above be considered as potential participants in this clinical investigation?

"Individuals aged between 18 and 49 years old are eligible for recruitment in this clinical trial."

Answered by AI

What is the current number of individuals actively engaged in this clinical investigation?

"Indeed, the details on clinicaltrials.gov indicate that this ongoing clinical trial is actively seeking eligible patients. The study was initially posted on February 1st, 2024 and recently updated on January 17th, 2024. Recruitment aims to enroll a total of 40 patients from a single designated site."

Answered by AI

Which individuals are eligible to participate in this clinical trial?

"To qualify for participation in this trial, candidates must meet two criteria: having gestational diabetes and falling within the age range of 18 to 49. The study aims to enroll a total of 40 individuals."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes

Landon, Mark B., Catherine Y. Spong, Elizabeth Thom, Marshall W. Carpenter, Susan M. Ramin, Brian Casey, Ronald J. Wapner, et al.. 2009. “A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0902430.

Diabetes CareJournal

Poor Reliability and Poor Adherence to Self-monitoring of Blood Glucose Are Common in Women with Gestational Diabetes Mellitus and May Be Associated with Poor Pregnancy Outcomes

Cosson, Emmanuel, Baz Baz, Françoise Gary, Isabelle Pharisien, Minh Tuan Nguyen, Dorian Sandre-Banon, Yahya Jaber, et al.. 2017. “Poor Reliability and Poor Adherence to Self-monitoring of Blood Glucose Are Common in Women with Gestational Diabetes Mellitus and May Be Associated with Poor Pregnancy Outcomes”. Diabetes Care. American Diabetes Association. doi:10.2337/dc17-0369.

clinicaltrials.govStudy

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

Andrea Shields 2024. "Meals 4 Moms: A Multilevel Community-based Lifestyle Intervention for GDM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06227247.