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

Not Applicable

Completed

• Conditions: Excessive Weight Gain During Pregnancy; Gestational Diabetes
• Interventions: Behavioral: Control group; Behavioral: Healthy lifestyle counseling

• Registration Number: NCT01782105
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	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.
Intervention group	Healthy lifestyle counseling	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).

Primary Outcome Measures

Name	Time	Method
Weight change during pregnancy	Weeks 12, 24, 36 of gestation

Secondary Outcome Measures

Name	Time	Method
Levels of maternal and fetal adipokines	Weeks 12, 24 of gestation and at delivery (in cord blood)
Maternal and fetal glycemic control	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.	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.	throughout the study	Documentation will be collected about appreciation of the participants and attendance.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada