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

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782105
• Other study ID #: I-CHANGE
• Status: Completed
• Phase: N/A
• First received: June 18, 2012
• Last updated: December 10, 2013
• Start date: December 2011
• Est. completion date: October 2013

Study information

• Verified date: December 2013
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational
• Excessive Weight Gain During Pregnancy
• Gestational Diabetes
• Weight Gain

Intervention

Behavioral:
• Healthy lifestyle counseling
Nutritionnal and physical activity counseling and physical activity session group
• Control group
Evaluation of nutritional and physcial activity habits

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Sherbrooke	Diabetes Québec, Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change during pregnancy		Weeks 12, 24, 36 of gestation	Yes
Secondary	Levels of maternal and fetal adipokines		Weeks 12, 24 of gestation and at delivery (in cord blood)	Yes
Secondary	Maternal and fetal glycemic control	Results of glucose tolerance test (50g and 75g)	Weeks 12, 24 of gestation and at delivery	Yes
Secondary	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)	Yes
Secondary	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	Yes