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

NCT01782105 | Completed DMC

• 1 other identifier: I-CHANGE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Excessive Weight Gain During Pregnancy; Gestational Diabetes

Keywords

weight gain; healthy lifestyle; gestational diabetes; adipokins; glycemic regulation

Outcome Measures

Primary Outcomes (1)

• Weight change during pregnancy

  Weeks 12, 24, 36 of gestation

Secondary Outcomes (4)

• Levels of maternal and fetal adipokines

  Weeks 12, 24 of gestation and at delivery (in cord blood)

• Maternal and fetal glycemic control

  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.

  throughout the study

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Intervention group

EXPERIMENTAL

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

Interventions

Healthy lifestyle counseling BEHAVIORAL

Nutritionnal and physical activity counseling and physical activity session group

Also known as: Intervention group

Intervention group

Control group BEHAVIORAL

Evaluation of nutritional and physcial activity habits

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Diabetes Québec: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

Location

MeSH Terms

Conditions

Diabetes, Gestational; Weight Gain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Marie-France Hivert, MD, MSc

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: February 1, 2013
• Study Start: December 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

CA (1)