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

Physical Activity Clinical Trial

— DEPART  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02872402
• Other study ID #: DEPART
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2025

Study information

• Verified date: April 2022
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Dietary Modification
• Physical Activity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
Canada	Institut sur la nutrition et les aliments fonctionnels	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight retention		12 months postpartum
Secondary	Waist circumference		12 months postpartum
Secondary	Body composition		12 months postpartum
Secondary	Glucose		12 months
Secondary	Insuline		12 months
Secondary	Oral glucose tolerance test (75g)		12 months
Secondary	Glycated hemoglobin		12 months
Secondary	Lipid profile		12 months
Secondary	Resting blood pressure		12 months
Secondary	Breastfeeding duration	, time physically active	12 months
Secondary	Healthy eating index		12 months
Secondary	Time physically active		12 months