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

This study has been completed.
Sponsor:
Collaborators:
Diabète Québec
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Marie-France Hivert, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01782105
First received: June 18, 2012
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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 Intervention
Excessive Weight Gain During Pregnancy
Gestational Diabetes
Behavioral: Healthy lifestyle counseling
Behavioral: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intervention en Changement Des Habitudes de Vie Par l'Activité Physique et un Support Nutritionnel Durant la Grossesse en Estrie

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Weight change during pregnancy [ Time Frame: Weeks 12, 24, 36 of gestation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Levels of maternal and fetal adipokines [ Time Frame: Weeks 12, 24 of gestation and at delivery (in cord blood) ] [ Designated as safety issue: Yes ]
  • Maternal and fetal glycemic control [ Time Frame: Weeks 12, 24 of gestation and at delivery ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
  • Optimize the intervention before measuring its impact on the prevention of gestational diabetes mellitus on a larger scale. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
    Documentation will be collected about appreciation of the participants and attendance.


Enrollment: 16
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Control group
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782105

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H5N4
Sponsors and Collaborators
Université de Sherbrooke
Diabète Québec
Fonds de la Recherche en Santé du Québec
Investigators
Principal Investigator: Marie-France Hivert, MD, MSc Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Marie-France Hivert, MD, MSc, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01782105     History of Changes
Other Study ID Numbers: I-CHANGE
Study First Received: June 18, 2012
Last Updated: December 10, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
weight gain
healthy lifestyle
gestational diabetes
adipokins
glycemic regulation

Additional relevant MeSH terms:
Diabetes Mellitus
Weight Gain
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Pregnancy Complications

ClinicalTrials.gov processed this record on April 22, 2014