Intervention to Promote Changes of Healthy Lifestyle (Physical Activity and Nutrition) During Gestation

Study Overview
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Brief Summary
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The purpose of this study are: Assess the impact of an intervention to the adoption of healthy lifestyles among pregnant women at high risk of gestational diabetes mellitus on: weight gain in pregnancy the levels of maternal and fetal adipokines and glycemic control maternal and fetal. Determine whether the adoption of healthy lifestyles in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.

Official Title
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Intervention en Changement Des Habitudes de Vie Par l'Activité Physique et un Support Nutritionnel Durant la Grossesse en Estrie

Conditions
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Excessive Weight Gain During Pregnancy, Gestational Diabetes

Intervention / Treatment
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* Behavioral: Healthy lifestyle counseling
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be aged ≥ 18 years, have a pre-pregnancy BMI ≥ 25 kg/m2, be at risk of developing a gestational diabetes mellitus (a history of gestational diabetes mellitus or glucose 1 hour post-50g > 7.1 mmol/L. Exclusion Criteria: Pre-pregnancy diabetes detected in the first trimester (A1c > 6.5%, fasting glucose > 7.0 mmol/L, random blood glucose> 11.1 mmol/L, glucose > 10.3 mmol/L 1 hour post-50g) twin pregnancy taking medications that can affect blood sugar or weight, practice ≥ 150 minutes of physical activity per week against formal-indication for physical activity.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>In addition to the usual monitoring of pregnancy, this group will receive information about the recommended weight gain during pregnancy and an evaluation about of their nutritional and physical activity habits. | Behavioral: Control group<br>* Evaluation of nutritional and physcial activity habits<br>|
| Experimental: Intervention group<br>This group will receive a regular monitoring by health professionals (nutritionist and kinesiologist) who will ensure nutritional changes and physical activity necessary to secure the adoption of a healthy lifestyle and could participate to a physical activity group session once a week until week 36 of gestation. The intervention include: A nutritional counseling every 2 weeks by a nutritionist until week 36 of gestation; a physical activity group session once a week lead by a kinesiologist until week 36 of gestation; 2 sessions of physical activity counseling (weeks 12 and 24). | Behavioral: Healthy lifestyle counseling<br>* Nutritionnal and physical activity counseling and physical activity session group<br>* Other names: Intervention group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change during pregnancy |  | Weeks 12, 24, 36 of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of maternal and fetal adipokines |  | Weeks 12, 24 of gestation and at delivery (in cord blood) | 
| Maternal and fetal glycemic control | Results of glucose tolerance test (50g and 75g) | Weeks 12, 24 of gestation and at delivery | 
| Determine whether the adoption of healthy lifestyle in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns. |  | Weeks 12, 24 of gestation and at delivery (cord blood) | 
| Optimize the intervention before measuring its impact on the prevention of gestational diabetes mellitus on a larger scale. | Documentation will be collected about appreciation of the participants and attendance. | throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight gain, healthy lifestyle, gestational diabetes, adipokins, glycemic regulation