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Trial record 7 of 7 for:    Open Studies | "Fetal Macrosomia" OR "Large for Gestational Age"

Impact of Diet and Exercise Activity on Pregnancy Outcomes (IDEA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Manitoba
Sponsor:
Collaborator:
Lawson Foundation, Public Health Agency of Canada
Information provided by (Responsible Party):
Garry Shen, University of Manitoba
ClinicalTrials.gov Identifier:
NCT00486629
First received: June 12, 2007
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The general goal of the present study is to assess the impact of a community-based exercise and dietary intervention in pregnant women living in urban areas during and after their pregnancy on the reduction of the risks of both diabetes and obesity in mothers and their offspring.

We hypothesize that a community-based lifestyle intervention program during and after gestation may improve pregnancy outcomes in terms of reducing the risk of developing obesity or type 2 DM in mothers and their children.


Condition Intervention Phase
Obesity
Gestational Diabetes
Type 2 Diabetes
Behavioral: Exercise and dietary education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of a Community-based Obesity and Diabetes Prevention Program on Pregnant Outcomes in Pregnant Women

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Excessive weight gain during pregnancy [ Time Frame: 2007-2014 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • macrosomia, requirement of delivery procedures [ Time Frame: 2007-2015 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: July 2004
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Exercise and dietary education
    Aerobic exercise or walk for 3-5 times/day for 30-45 min/time from 20 weeks to 36 weeks of pregnancy. Dietary education on nutrition for healthy pregnancy through weekly class during pregnancy.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnancy < 20 weeks.
  • Expressed interest in study and willingness to consent to participate in the study.

Exclusion Criteria:

  • Obstetric or medical contraindications for exercise according to 2002 SOCG guideline (ruptured membranes, preterm labor, incompetent cervix, hypertensive disorders of pregnancy, growth restricted fetus, placenta previa, persistent bleeding in 2nd or 3rd trimester, significant metabolic, cardiovascular, respiratory or systemic disorder) (5, 6).
  • Pre-existing diabetes (except a history of GDM, but not in current pregnancy).
  • Multiple gestations.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486629

Contacts
Contact: Garry Shen, MD PhD 204-789-3816 gshen@ms.umanitoba.ca

Locations
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Contact: Garry Shen, MD PhD    204-789-3816    gshen@ms.umanitoba.ca   
Sponsors and Collaborators
University of Manitoba
Lawson Foundation, Public Health Agency of Canada
Investigators
Study Chair: Garry Shen, MD PhD University of Manitoba
  More Information

Additional Information:
No publications provided by University of Manitoba

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Garry Shen, Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT00486629     History of Changes
Other Study ID Numbers: GRT 2006-021
Study First Received: June 12, 2007
Last Updated: July 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Exercise
Diet
Pregnancy
Obesity
Macrosomia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Obesity
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Pregnancy Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014