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

NCT ID: NCT01782105

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-10-31

Brief Summary

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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

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Conditions

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Excessive Weight Gain During Pregnancy Gestational Diabetes

Keywords

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weight gain healthy lifestyle gestational diabetes adipokins glycemic regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type BEHAVIORAL

Evaluation of nutritional and physcial activity habits

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).

Group Type EXPERIMENTAL

Healthy lifestyle counseling

Intervention Type BEHAVIORAL

Nutritionnal and physical activity counseling and physical activity session group

Interventions

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Healthy lifestyle counseling

Nutritionnal and physical activity counseling and physical activity session group

Intervention Type BEHAVIORAL

Control group

Evaluation of nutritional and physcial activity habits

Intervention Type BEHAVIORAL

Other Intervention Names

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Intervention group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Diabetes Québec

OTHER

Sponsor Role collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Marie-France Hivert

MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie-France Hivert, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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I-CHANGE

Identifier Type: -

Identifier Source: org_study_id