Back to resultsImpact of Diet and Exercise Activity on Pregnancy Outcomes (IDEA)
Primary Purpose
Obesity, Gestational Diabetes, Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise and dietary education
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Exercise, Diet, Pregnancy, Obesity, Macrosomia
Eligibility 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.
Sites / Locations
- University of ManitobaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Lifestyle intervention
No intervention
Outcomes
Primary Outcome Measures
Excessive weight gain during pregnancy
Secondary Outcome Measures
macrosomia, requirement of delivery procedures
Full Information
NCT ID
NCT00486629
First Posted
June 12, 2007
Last Updated
May 8, 2023
Sponsor
University of Manitoba
Collaborators
The Lawson Foundation, Public Health Agency of Canada (PHAC)
1. Study Identification
Unique Protocol Identification Number
NCT00486629
Brief Title
Impact of Diet and Exercise Activity on Pregnancy Outcomes
Acronym
IDEA
Official Title
Impact of a Community-based Obesity and Diabetes Prevention Program on Pregnant Outcomes in Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2004 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
The Lawson Foundation, Public Health Agency of Canada (PHAC)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Gestational Diabetes, Type 2 Diabetes
Keywords
Exercise, Diet, Pregnancy, Obesity, Macrosomia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Lifestyle questionnaire on mothers and offspring. Tests on glucose tolerance and epigenetic analysis in offspring.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Lifestyle intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise and dietary education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Excessive weight gain during pregnancy
Time Frame
2007-2023
Secondary Outcome Measure Information:
Title
macrosomia, requirement of delivery procedures
Time Frame
2007-2025
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Garry Shen, MD PhD
Phone
204-789-3816
Email
gshen@ms.umanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garry Shen, MD PhD
Organizational Affiliation
University of Manitoba
Official's Role
Study Chair
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garry Shen, MD PhD
Phone
204-789-3816
Email
gshen@ms.umanitoba.ca
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
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
Citations:
PubMed Identifier
25248797
Citation
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.
Results Reference
derived
Links:
URL
http://www.momsinmotion.ca
Description
Related Info
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Impact of Diet and Exercise Activity on Pregnancy Outcomes
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