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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00486629
Other study ID # GRT 2006-021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 2004
Est. completion date July 2026

Study information

Verified date May 2023
Source University of Manitoba
Contact Garry Shen, MD PhD
Phone 204-789-3816
Email gshen@ms.umanitoba.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Impact of lifestyle intervention on excessive gestational weight gain


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date July 2026
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


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.

Locations

Country Name City State
Canada University of Manitoba Winnipeg Manitoba

Sponsors (3)

Lead Sponsor Collaborator
University of Manitoba Public Health Agency of Canada (PHAC), The Lawson Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Excessive weight gain during pregnancy 2007-2023
Secondary macrosomia, requirement of delivery procedures 2007-2025
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