Trial record 7 of 10 for:
Open Studies | "Fetal Macrosomia" OR "Large for Gestational Age"
Impact of Diet and Exercise Activity on Pregnancy Outcomes (IDEA)
This study is currently recruiting participants.
Verified July 2012 by University of Manitoba
Sponsor:
University of Manitoba
Collaborator:
Lawson Foundation, Public Health Agency of Canada
Information provided by (Responsible Party):
Garry Shen, University of Manitoba
ClinicalTrials.gov Identifier:
NCT00486629
First received: June 12, 2007
Last updated: July 13, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|---|
|
Obesity 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: | 500 |
| Study Start Date: | July 2004 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486629
Contacts
| Contact: Garry Shen, MD PhD | 204-789-3816 | gshen@ms.umanitoba.ca |
Locations
| Canada, Manitoba | |
| University of Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Contact: Garry Shen, MD PhD 204-789-3816 gshen@ms.umanitoba.ca | |
Sponsors and Collaborators
University of Manitoba
Lawson Foundation, Public Health Agency of Canada
Investigators
| Study Chair: | Garry Shen, MD PhD | University of Manitoba |
More Information
Additional Information:
No publications provided
| Responsible Party: | Garry Shen, Professor, University of Manitoba |
| ClinicalTrials.gov Identifier: | NCT00486629 History of Changes |
| Other Study ID Numbers: | GRT 2006-021 |
| Study First Received: | June 12, 2007 |
| Last Updated: | July 13, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Manitoba:
|
Exercise Diet Pregnancy Obesity Macrosomia |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Diabetes, Gestational Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Pregnancy Complications |
ClinicalTrials.gov processed this record on May 16, 2013