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Clinical Trials/NCT02872402
NCT02872402
Active, Not Recruiting
N/A

Feasibility of a Lifestyle Intervention Early After Delivery on the Cardiometabolic Risk Profile of Women With Recent Gestational Diabetes

Laval University1 site in 1 country30 target enrollmentDecember 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dietary Modification
Sponsor
Laval University
Enrollment
30
Locations
1
Primary Endpoint
Weight retention
Status
Active, Not Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
December 2025
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julie Robitaille

Associate Professor

Laval University

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

Outcomes

Primary Outcomes

Weight retention

Time Frame: 12 months postpartum

Secondary Outcomes

  • Insuline(12 months)
  • Healthy eating index(12 months)
  • Glucose(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)

Study Sites (1)

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