An interventional study of Lifestyle intervention and Active control lifestyle intervention in Dietary Modification, Weight Loss and Physical Activity, sponsored by Laval University. Active, not recruiting at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by Laval University · Not applicable, Interventional, and Prevention
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.
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.
1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.
This study's planned enrollment of 30 is below the median of 73 across 1,496 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
At 2-mo postpartum, women will start the 1-yr lifestyle intervention that will consist of 7 face-to-face individual sessions of 1-hr (at 2, 3, 4, 5, 6, 9, 12 mo postpartum and a follow-up at 18 mo). Metabolic and anthropometric measurements will be assessed at 2,6,12 and 18 mo postpartum. In addition, 7 individual sessions of 30 min between face-to-face sessions will be carried out on the phone. Benefits of exclusive breastfeeding, healthy eating and physical activity will be portrayed at each visit .
Behavioral: Lifestyle intervention
Women in the control group will come to the testing unit at 2, 6, 12 and 18 mo postpartum for metabolic and anthropometric measurements and at 3, 4, 5, 9 mo for weight measurements only. They will receive standard lifestyle recommendations in the form of written information at each visit.
Behavioral: Active control 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.
Participants in the control group will receive standard lifestyle recommendations in the form of written information at each visit.
Weight retention
Time frame: 12 months postpartum
Waist circumference
Time frame: 12 months postpartum
Body composition
Time frame: 12 months postpartum
Glucose
Time frame: 12 months
Insuline
Time frame: 12 months
Oral glucose tolerance test (75g)
Time frame: 12 months
Glycated hemoglobin
Time frame: 12 months
Lipid profile
Time frame: 12 months
Resting blood pressure
Time frame: 12 months
Breastfeeding duration
, time physically active
Time frame: 12 months
Healthy eating index
Time frame: 12 months
Time physically active
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Laval University