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

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes; Excessive Weight Gain During Pregnancy
• Intervention / Treatment: Behavioral: Control group; Behavioral: Healthy lifestyle counseling

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H5N4
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Fonds de la Recherche en Santé du Québec; Diabetes Québec
• Investigators: Principal Investigator: Marie-France Hivert, MD, MSc, Universite de Sherbrooke

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: June 18, 2012
• First Submitted That Met QC Criteria: January 30, 2013
• First Posted (Estimate): February 1, 2013

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: healthy lifestyle; gestational diabetes; weight gain; adipokins; glycemic regulation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Pregnancy Complications; Body Weight Changes; Weight Gain; Diabetes, Gestational
• Other Study ID Numbers: I-CHANGE