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Lifestyle Intervention for Gestational Diabetes Postpartum Care (DEPART Trial)

N/A

Waitlist Available

Led By Julie Robitaille, RD PhD

Research Sponsored by Laval University

Eligibility Criteria Checklist

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

Must have

Pregnant women diagnosed with GDM

At least 18 yrs old

Must not have

Women with a history of type 1 or type 2 diabetes

Women with a multiple pregnancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand how best to help new mothers who have had gestational diabetes minimize their weight retention.

Who is the study for?

This trial is for women over 18 who had a single baby recently, were diagnosed with gestational diabetes (GDM), and have a pre-pregnancy BMI of at least 18.5. They must speak French fluently and not plan to get pregnant in the next year or have had bariatric surgery or any type of diabetes before.

What is being tested?

The study tests if a program encouraging exclusive breastfeeding, healthy eating, and regular exercise can help women with recent GDM lose weight after giving birth. Participants will be compared to an active control group also following lifestyle changes.

What are the potential side effects?

Since this trial involves lifestyle changes rather than medication, side effects may include typical challenges related to dieting and exercising such as muscle soreness or fatigue from physical activity.

Eligibility Criteria

Inclusion Criteria

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

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I am pregnant and have been diagnosed with gestational diabetes.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman with a history of diabetes.

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I am pregnant with more than one baby.

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I have had weight loss surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Breastfeeding duration

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention

At 2-mo postpartum, women will start the 1-yr lifestyle intervention that will consist of 7 face-to-face individual sessions of 1-hr (at 2, 3, 4, 5, 6, 9, 12 mo postpartum and a follow-up at 18 mo). Metabolic and anthropometric measurements will be assessed at 2,6,12 and 18 mo postpartum. In addition, 7 individual sessions of 30 min between face-to-face sessions will be carried out on the phone. Benefits of exclusive breastfeeding, healthy eating and physical activity will be portrayed at each visit .

Group II: Active control lifestyle interventionActive Control1 Intervention

Women in the control group will come to the testing unit at 2, 6, 12 and 18 mo postpartum for metabolic and anthropometric measurements and at 3, 4, 5, 9 mo for weight measurements only. They will receive standard lifestyle recommendations in the form of written information at each visit.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lifestyle intervention

2011

Completed Phase 4

~68950

0 / 5Eligibility criteria met