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

This study is currently recruiting participants.
Verified February 2016 by Garry Shen, University of Manitoba
Sponsor:
ClinicalTrials.gov Identifier:
NCT00486629
First Posted: June 14, 2007
Last Update Posted: February 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
The Lawson Foundation
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Garry Shen, University of Manitoba
  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
Intervention Model: Parallel Assignment
Masking: None (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 Garry Shen, University of Manitoba:

Primary Outcome Measures:
  • Excessive weight gain during pregnancy [ Time Frame: 2007-2014 ]

Secondary Outcome Measures:
  • macrosomia, requirement of delivery procedures [ Time Frame: 2007-2015 ]

Estimated Enrollment: 1000
Study Start Date: July 2004
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Lifestyle intervention
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.
No Intervention: Control
No internvetion

Detailed Description:
Impact of lifestyle intervention on excessive gestational weight gain
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
The Lawson Foundation
Public Health Agency of Canada (PHAC)
Investigators
Study Chair: Garry Shen, MD PhD University of Manitoba
  More Information

Additional Information:
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
First Submitted: June 12, 2007
First Posted: June 14, 2007
Last Update Posted: February 22, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  1. Hui A, Back L, Ludwig S, Gardiner P, Sevenhuysen G, Dean H, Sellers E, McGavock J, Morris M, Bruce S, Murray R, Shen GX. Lifestyle intervention on diet and exercise reduced excessive gestational weight gain in pregnant women under a randomized controlled trial. Br J Obstetr Gynecol 2012;119:70-77
  2. Hui AL, Back L, Ludwig S, Gardiner P, Sevenhuysen G, Dean HJ, Sellers E, McGavock J, Morris M, Jiang D, Shen GX. Effects of lifestyle intervention on dietary intake, physical activity level, and gestational weight gain in pregnant women with different pre-pregnancy Body Mass Index in a randomized control trial. BMC Pregnancy Childbirth. 2014;14:331. PMID:25248797

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

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