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Completed

NCT Number: NCT01782105

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healthy Lifestyle Counseling

Behavioral

Nutritionnal and physical activity counseling and physical activity session group

Other names: Intervention group

Control Group

Behavioral

Evaluation of nutritional and physcial activity habits

Primary outcomes

  1. Weight change during pregnancy

    Time frame: Weeks 12, 24, 36 of gestation

Secondary outcomes

  1. Levels of maternal and fetal adipokines

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

  2. Maternal and fetal glycemic control

    Time frame: Weeks 12, 24 of gestation and at delivery

    Results of glucose tolerance test (50g and 75g)

  3. 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)

  4. Optimize the intervention before measuring its impact on the prevention of gestational diabetes mellitus on a larger scale.

    Time frame: throughout the study

    Documentation will be collected about appreciation of the participants and attendance.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Diabetes Québec
  • Fonds de la Recherche en Santé du Québec

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 1, 2013
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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