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

Primary Purpose

Dietary Modification, Weight Loss, Physical Activity

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lifestyle intervention
Active control lifestyle intervention
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dietary Modification focused on measuring gestational diabetes, dietary modification, weight loss, physical activity, breastfeeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Institut sur la nutrition et les aliments fonctionnels

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Active control lifestyle intervention

Arm Description

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 .

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.

Outcomes

Primary Outcome Measures

Weight retention

Secondary Outcome Measures

Waist circumference
Body composition
Glucose
Insuline
Oral glucose tolerance test (75g)
Glycated hemoglobin
Lipid profile
Resting blood pressure
Breastfeeding duration
, time physically active
Healthy eating index
Time physically active

Full Information

First Posted
August 4, 2016
Last Updated
April 7, 2022
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT02872402
Brief Title
Feasibility of a Postpartum Lifestyle Intervention on the Cardiometabolic Risk Profile of GDM Women
Acronym
DEPART
Official Title
Feasibility of a Lifestyle Intervention Early After Delivery on the Cardiometabolic Risk Profile of Women With Recent Gestational Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2016 (Actual)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Modification, Weight Loss, Physical Activity, Breastfeeding
Keywords
gestational diabetes, dietary modification, weight loss, physical activity, breastfeeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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 .
Arm Title
Active control lifestyle intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active control lifestyle intervention
Intervention Description
Participants in the control group will receive standard lifestyle recommendations in the form of written information at each visit.
Primary Outcome Measure Information:
Title
Weight retention
Time Frame
12 months postpartum
Secondary Outcome Measure Information:
Title
Waist circumference
Time Frame
12 months postpartum
Title
Body composition
Time Frame
12 months postpartum
Title
Glucose
Time Frame
12 months
Title
Insuline
Time Frame
12 months
Title
Oral glucose tolerance test (75g)
Time Frame
12 months
Title
Glycated hemoglobin
Time Frame
12 months
Title
Lipid profile
Time Frame
12 months
Title
Resting blood pressure
Time Frame
12 months
Title
Breastfeeding duration
Description
, time physically active
Time Frame
12 months
Title
Healthy eating index
Time Frame
12 months
Title
Time physically active
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Robitaille, RD PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut sur la nutrition et les aliments fonctionnels
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V0A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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