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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Physical Activity; Weight Loss; Dietary Modification; Breastfeeding
• Intervention / Treatment: Behavioral: Lifestyle intervention; Behavioral: Active control lifestyle intervention

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1V0A6
      • Institut sur la nutrition et les aliments fonctionnels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight retention	12 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference		12 months postpartum
Body composition		12 months postpartum
Glucose		12 months
Insuline		12 months
Oral glucose tolerance test (75g)		12 months
Glycated hemoglobin		12 months
Lipid profile		12 months
Resting blood pressure		12 months
Breastfeeding duration	, time physically active	12 months
Healthy eating index		12 months
Time physically active		12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): October 1, 2020
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 15, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; breastfeeding; weight loss; gestational diabetes; dietary modification
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: DEPART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO