DEPART: Feasibility of a Postpartum Lifestyle Intervention on the Cardiometabolic Risk Profile of GDM Women

Sponsor
Laval University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02872402
Collaborator
(none)
30
1
2
108
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyle intervention
  • Behavioral: Active control lifestyle intervention
N/A

Detailed Description

Women with a history of gestational diabetes (GDM) are characterized by increased risk for subsequent type 2 diabetes (T2D) and cardiovascular disease (CVD). These women are also characterized by higher body mass index (BMI) and waist circumference compared to women without prior GDM. Failure to lose the weight gained during pregnancy can lead to increased BMI for subsequent pregnancies. As such, the childbearing-age period has been described as a potential period of weight gain and represents a critical window for the development of obesity, T2D and CVD. Therefore, strategies aiming at preventing postpartum weight retention (WR) and early cardiometabolic alterations in women with a history of GDM are of paramount importance. Principal investigator have shown that a low diet quality score was associated with greater adiposity and lower insulin sensitivity in women with prior GDM. Furthermore, less than 10% of women with prior GDM met the recommendations for breastfeeding, nutrition, and physical activity. Investigators have shown that attitude and perceived behavioral control were significant predictors of the intention to adopt healthy eating. For those who did engage in healthy behaviors, lower prevalence of cardiometabolic alterations was observed, providing supportive evidence that the adoption of healthy behaviors may be key to prevent the progression to an altered cardiometabolic profile.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Feasibility of a Lifestyle Intervention Early After Delivery on the Cardiometabolic Risk Profile of Women With Recent Gestational Diabetes
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

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 .

Behavioral: Lifestyle intervention
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.

Active Comparator: Active control lifestyle 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.

Behavioral: Active control lifestyle intervention
Participants in the control group will receive standard lifestyle recommendations in the form of written information at each visit.

Outcome Measures

Primary Outcome Measures

  1. Weight retention [12 months postpartum]

Secondary Outcome Measures

  1. Waist circumference [12 months postpartum]

  2. Body composition [12 months postpartum]

  3. Glucose [12 months]

  4. Insuline [12 months]

  5. Oral glucose tolerance test (75g) [12 months]

  6. Glycated hemoglobin [12 months]

  7. Lipid profile [12 months]

  8. Resting blood pressure [12 months]

  9. Breastfeeding duration [12 months]

    , time physically active

  10. Healthy eating index [12 months]

  11. Time physically active [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut sur la nutrition et les aliments fonctionnels Quebec City Quebec Canada G1V0A6

Sponsors and Collaborators

  • Laval University

Investigators

  • Principal Investigator: Julie Robitaille, RD PhD, Laval University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Julie Robitaille, Associate Professor, Laval University
ClinicalTrials.gov Identifier:
NCT02872402
Other Study ID Numbers:
  • DEPART
First Posted:
Aug 19, 2016
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Julie Robitaille, Associate Professor, Laval University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022