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

Primary Purpose

Excessive Weight Gain During Pregnancy, Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Healthy lifestyle counseling
Control group
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Excessive Weight Gain During Pregnancy focused on measuring weight gain, healthy lifestyle, gestational diabetes, adipokins, glycemic regulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Universitaire de Sherbrooke

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Weight change during pregnancy

Secondary Outcome Measures

Levels of maternal and fetal adipokines
Maternal and fetal glycemic control
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.
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.

Full Information

First Posted
June 18, 2012
Last Updated
December 10, 2013
Sponsor
Université de Sherbrooke
Collaborators
Diabetes Québec, Fonds de la Recherche en Santé du Québec
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1. Study Identification

Unique Protocol Identification Number
NCT01782105
Brief Title
Intervention to Promote Changes of Healthy Lifestyle (Physical Activity and Nutrition) During Gestation
Official Title
Intervention en Changement Des Habitudes de Vie Par l'Activité Physique et un Support Nutritionnel Durant la Grossesse en Estrie
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
Diabetes Québec, Fonds de la Recherche en Santé du Québec

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excessive Weight Gain During Pregnancy, Gestational Diabetes
Keywords
weight gain, healthy lifestyle, gestational diabetes, adipokins, glycemic regulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Healthy lifestyle counseling
Other Intervention Name(s)
Intervention group
Intervention Description
Nutritionnal and physical activity counseling and physical activity session group
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Evaluation of nutritional and physcial activity habits
Primary Outcome Measure Information:
Title
Weight change during pregnancy
Time Frame
Weeks 12, 24, 36 of gestation
Secondary Outcome Measure Information:
Title
Levels of maternal and fetal adipokines
Time Frame
Weeks 12, 24 of gestation and at delivery (in cord blood)
Title
Maternal and fetal glycemic control
Description
Results of glucose tolerance test (50g and 75g)
Time Frame
Weeks 12, 24 of gestation and at delivery
Title
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)
Title
Optimize the intervention before measuring its impact on the prevention of gestational diabetes mellitus on a larger scale.
Description
Documentation will be collected about appreciation of the participants and attendance.
Time Frame
throughout the study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-France Hivert, MD, MSc
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada

12. IPD Sharing Statement

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

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