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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University of Manitoba
The Lawson Foundation
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Garry Shen, University of Manitoba Identifier:
First received: June 12, 2007
Last updated: February 18, 2016
Last verified: February 2016

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
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: 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

Ages Eligible for Study:   18 Years and older
Genders 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.
  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 identifier: NCT00486629

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

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)
Study Chair: Garry Shen, MD PhD University of Manitoba
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Garry Shen, Professor, University of Manitoba Identifier: NCT00486629     History of Changes
Other Study ID Numbers: GRT 2006-021 
Study First Received: June 12, 2007
Last Updated: February 18, 2016
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications processed this record on April 27, 2016