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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02872402
Acronym
DEPART
Enrollment
30
Registered
2016-08-19
Start date
2016-12-31
Completion date
2025-12-31
Last updated
2022-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Dietary Modification, Physical Activity, Weight Loss

Keywords

gestational diabetes, dietary modification, weight loss, physical activity, breastfeeding

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.

Interventions

BEHAVIORALLifestyle 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.

BEHAVIORALActive control lifestyle intervention

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

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Weight retention12 months postpartum

Secondary

MeasureTime frameDescription
Body composition12 months postpartum
Glucose12 months
Insuline12 months
Oral glucose tolerance test (75g)12 months
Glycated hemoglobin12 months
Waist circumference12 months postpartum
Resting blood pressure12 months
Breastfeeding duration12 months, time physically active
Healthy eating index12 months
Time physically active12 months
Lipid profile12 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026