Clinical trial NCT02872402: Feasibility of a Postpartum Lifestyle Intervention on the Cardiometabolic Risk Profile of GDM Women
Official title: Feasibility of a Lifestyle Intervention Early After Delivery on the Cardiometabolic Risk Profile of Women With Recent Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dietary Modification
Weight Loss
Physical Activity
Breastfeeding
Keywords: gestational diabetes
dietary modification
weight loss
physical activity
breastfeeding
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Weight retention
timeFrame: 12 months postpartum
Secondary outcomes:
measure: Waist circumference
timeFrame: 12 months postpartum
measure: Body composition
timeFrame: 12 months postpartum
measure: Glucose
timeFrame: 12 months
measure: Insuline
timeFrame: 12 months
measure: Oral glucose tolerance test (75g)
timeFrame: 12 months
measure: Glycated hemoglobin
timeFrame: 12 months
measure: Lipid profile
timeFrame: 12 months
measure: Resting blood pressure
timeFrame: 12 months
measure: Breastfeeding duration
timeFrame: 12 months
measure: Healthy eating index
timeFrame: 12 months
measure: Time physically active
timeFrame: 12 months
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Institut sur la nutrition et les aliments fonctionnels
state: Quebec
Study officials:
affiliation: Laval University
name: Julie Robitaille, RD PhD
role: PRINCIPAL_INVESTIGATOR
References: