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

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. Identifier: NCT00486629
Recruitment Status : Recruiting
First Posted : June 14, 2007
Last Update Posted : September 3, 2020
The Lawson Foundation
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Garry Shen, University of Manitoba

Brief Summary:

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 or disease Intervention/treatment Phase
Obesity Gestational Diabetes Type 2 Diabetes Behavioral: Exercise and dietary education Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Lifestyle questionnaire on mothers and offspring. Tests on glucose tolerance and epigenetic analysis in offspring.
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
Study Start Date : July 2004
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : July 2025

Arm Intervention/treatment
Experimental: Intervention
Lifestyle intervention
Behavioral: Exercise and dietary education
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 intervention

Primary Outcome Measures :
  1. Excessive weight gain during pregnancy [ Time Frame: 2007-2023 ]

Secondary Outcome Measures :
  1. macrosomia, requirement of delivery procedures [ Time Frame: 2007-2025 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00486629

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Contact: Garry Shen, MD PhD 204-789-3816

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Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Contact: Garry Shen, MD PhD    204-789-3816   
Sponsors and Collaborators
University of Manitoba
The Lawson Foundation
Public Health Agency of Canada (PHAC)
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Study Chair: Garry Shen, MD PhD University of Manitoba
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Garry Shen, Professor, University of Manitoba Identifier: NCT00486629    
Other Study ID Numbers: GRT 2006-021
First Posted: June 14, 2007    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  1. Hui A, Back L, Ludwig S, Sellers E, McGavock J, Morris M, Bruce S, 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:
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Pregnancy Complications