Feasibility of a Postpartum Lifestyle Intervention on the Cardiometabolic Risk Profile of GDM Women
DEPART
Feasibility of a Lifestyle Intervention Early After Delivery on the Cardiometabolic Risk Profile of Women With Recent Gestational Diabetes
1 other identifier
interventional
30
1 country
1
Brief Summary
The goal of the study is to investigate the effect of a lifestyle intervention program (adoption of exclusive breastfeeding, healthy diet and regular physical activity) on minimizing postpartum weight retention among women with recent GDM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2016
CompletedFirst Posted
Study publicly available on registry
August 19, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 8, 2022
April 1, 2022
3.8 years
August 4, 2016
April 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight retention
12 months postpartum
Secondary Outcomes (11)
Waist circumference
12 months postpartum
Body composition
12 months postpartum
Glucose
12 months
Insuline
12 months
Oral glucose tolerance test (75g)
12 months
- +6 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALAt 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 .
Active control lifestyle intervention
ACTIVE COMPARATORWomen 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.
Interventions
Women who are still breastfeeding at the first postpartum visit will be encouraged to pursue. References to local breastfeeding supporting groups will be done, if needed. The intervention will be conducted in order to reach recommendations for food servings and nutrient needs. Particular attention will be paid to increase fruits, vegetables, fish and whole grains intake, and decrease added sugars and high fat meat/dairy products. Women will be strongly encouraged to be active at least 150 min/week. They will be provided with targeted strategies for exercising, types of exercises and tips for including physical activity into the daily routine as well as fun exercises for the whole family.
Participants in the control group will receive standard lifestyle recommendations in the form of written information at each visit.
Eligibility Criteria
You may qualify if:
- Pregnant women diagnosed with GDM
- Fluent in French
- Had a singleton pregnancy
- At least 18 yrs old
- With a reported pre-pregnancy BMI ≥18.5 kg/m2
You may not qualify if:
- Women who had bariatric surgery
- Women who plan another pregnancy in the following year
- Women with a history of type 1 or type 2 diabetes
- Women with a multiple pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
Study Sites (1)
Institut sur la nutrition et les aliments fonctionnels
Québec, Quebec, G1V0A6, Canada
Related Publications (3)
Petitclerc I, Perron J, Dugas C, Mayer T, Raymond F, Di Marzo V, Veilleux A, Robitaille J. Association between gestational diabetes mellitus, maternal health and diet, and gut microbiota in mother-infant dyads. BMC Pregnancy Childbirth. 2025 Apr 24;25(1):486. doi: 10.1186/s12884-025-07584-2.
PMID: 40275186DERIVEDFradet A, Castonguay-Paradis S, Dugas C, Perron J, St-Arnaud G, Marc I, Doyen A, Flamand N, Dahhani F, Di Marzo V, Veilleux A, Robitaille J. The human milk endocannabinoidome and neonatal growth in gestational diabetes. Front Endocrinol (Lausanne). 2024 Jun 13;15:1415630. doi: 10.3389/fendo.2024.1415630. eCollection 2024.
PMID: 38938519DERIVEDDugas C, Laberee L, Perron J, St-Arnaud G, Richard V, Perreault V, Leblanc N, Marc I, Di Marzo V, Doyen A, Veilleux A, Robitaille J. Gestational Diabetes Mellitus, Human Milk Composition, and Infant Growth. Breastfeed Med. 2023 Jan;18(1):14-22. doi: 10.1089/bfm.2022.0085. Epub 2022 Nov 21.
PMID: 36409543DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie Robitaille, RD PhD
Laval University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 4, 2016
First Posted
August 19, 2016
Study Start
December 1, 2016
Primary Completion
October 1, 2020
Study Completion
December 1, 2025
Last Updated
April 8, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share