Intervention to Promote Changes of Healthy Lifestyle (Physical Activity and Nutrition) During Gestation
|ClinicalTrials.gov Identifier: NCT01782105|
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : December 11, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Excessive Weight Gain During Pregnancy Gestational Diabetes||Behavioral: Healthy lifestyle counseling Behavioral: Control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intervention en Changement Des Habitudes de Vie Par l'Activité Physique et un Support Nutritionnel Durant la Grossesse en Estrie|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||October 2013|
Active Comparator: Control group
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
Evaluation of nutritional and physcial activity habits
Experimental: Intervention group
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
Nutritionnal and physical activity counseling and physical activity session group
Other Name: Intervention group
- Weight change during pregnancy [ Time Frame: Weeks 12, 24, 36 of gestation ]
- Levels of maternal and fetal adipokines [ Time Frame: Weeks 12, 24 of gestation and at delivery (in cord blood) ]
- Maternal and fetal glycemic control [ Time Frame: Weeks 12, 24 of gestation and at delivery ]Results of glucose tolerance test (50g and 75g)
- 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. [ Time Frame: 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. [ Time Frame: throughout the study ]Documentation will be collected about appreciation of the participants and attendance.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782105
|Centre Hospitalier Universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H5N4|
|Principal Investigator:||Marie-France Hivert, MD, MSc||Université de Sherbrooke|