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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2013 by University of Manitoba.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Lawson Foundation
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Garry Shen, University of Manitoba
ClinicalTrials.gov Identifier:
NCT00486629
First received: June 12, 2007
Last updated: December 1, 2014
Last verified: July 2013

June 12, 2007
December 1, 2014
July 2004
June 2015   (final data collection date for primary outcome measure)
Excessive weight gain during pregnancy [ Time Frame: 2007-2014 ] [ Designated as safety issue: Yes ]
Excessive weight gain during pregnancy
Complete list of historical versions of study NCT00486629 on ClinicalTrials.gov Archive Site
macrosomia, requirement of delivery procedures [ Time Frame: 2007-2015 ] [ Designated as safety issue: Yes ]
macrosomia, requirement of delivery procedures
Not Provided
Not Provided
 
Impact of Diet and Exercise Activity on Pregnancy Outcomes
Impact of a Community-based Obesity and Diabetes Prevention Program on Pregnant Outcomes in Pregnant Women

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.

Impact of lifestyle intervention on excessive gestational weight gain

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Obesity
  • Gestational Diabetes
  • Type 2 Diabetes
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.
Experimental: Intervention
Lifestyle intervention
Intervention: Behavioral: Exercise and dietary education
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 Sep 24;14:331. doi: 10.1186/1471-2393-14-331.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Not Provided
June 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact: Garry Shen, MD PhD 204-789-3816 gshen@ms.umanitoba.ca
Canada
 
NCT00486629
GRT 2006-021
Yes
Garry Shen, University of Manitoba
University of Manitoba
  • The Lawson Foundation
  • Public Health Agency of Canada (PHAC)
Study Chair: Garry Shen, MD PhD University of Manitoba
University of Manitoba
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP