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

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ClinicalTrials.gov Identifier: NCT00486629
Recruitment Status : Recruiting
First Posted : June 14, 2007
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
The Lawson Foundation
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Garry Shen, University of Manitoba

Tracking Information
First Submitted Date  ICMJE June 12, 2007
First Posted Date  ICMJE June 14, 2007
Last Update Posted Date September 26, 2019
Study Start Date  ICMJE July 2004
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
Excessive weight gain during pregnancy [ Time Frame: 2007-2023 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2007)
Excessive weight gain during pregnancy
Change History Complete list of historical versions of study NCT00486629 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
macrosomia, requirement of delivery procedures [ Time Frame: 2007-2025 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2007)
macrosomia, requirement of delivery procedures
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Diet and Exercise Activity on Pregnancy Outcomes
Official Title  ICMJE Impact of a Community-based Obesity and Diabetes Prevention Program on Pregnant Outcomes in Pregnant Women
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.

Detailed Description Impact of lifestyle intervention on excessive gestational weight gain
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Obesity
  • Gestational Diabetes
  • Type 2 Diabetes
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intervention
    Lifestyle intervention
    Intervention: Behavioral: Exercise and dietary education
  • No Intervention: Control
    No intervention
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2016)
1000
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Garry Shen, MD PhD 204-789-3816 gshen@ms.umanitoba.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00486629
Other Study ID Numbers  ICMJE GRT 2006-021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Responsible Party Garry Shen, University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE
  • The Lawson Foundation
  • Public Health Agency of Canada (PHAC)
Investigators  ICMJE
Study Chair: Garry Shen, MD PhD University of Manitoba
PRS Account University of Manitoba
Verification Date September 2019

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