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

Not Applicable

Active, not recruiting

• Conditions: Dietary Modification; Breastfeeding; Weight Loss; Physical Activity

• Registration Number: NCT02872402
• Lead Sponsor: Laval University

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.

Study Timeline

• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-19
• Study Start: 2016-12
• Primary Completion: 2020-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight retention	12 months postpartum

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut sur la nutrition et les aliments fonctionnels; 🇨🇦 Quebec City, Quebec, Canada