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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 belowSelect...
I am pregnant and have been diagnosed with gestational diabetes.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am a woman with a history of diabetes.
Select...
I am pregnant with more than one baby.
Select...
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
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
Find a Location
Who is running the clinical trial?
Laval UniversityLead Sponsor
427 Previous Clinical Trials
174,854 Total Patients Enrolled
Julie Robitaille, RD PhDPrincipal InvestigatorLaval University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman with a history of diabetes.I am pregnant with more than one baby.I am pregnant and have been diagnosed with gestational diabetes.I am fluent in French.I am 18 years old or older.I have had weight loss surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: Active control lifestyle intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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