Impact of Diet and Exercise Activity on Pregnancy Outcomes

NCT ID: NCT00486629

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2028-07-31

Brief Summary

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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

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Impact of lifestyle intervention on excessive gestational weight gain

Conditions

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Obesity Gestational Diabetes Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Lifestyle questionnaire on mothers and offspring. Tests on glucose tolerance and epigenetic analysis in offspring.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Lifestyle intervention

Group Type EXPERIMENTAL

Exercise and dietary education

Intervention Type 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.

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Lawson Foundation

OTHER

Sponsor Role collaborator

Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Garry Shen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Garry Shen, MD PhD

Role: STUDY_CHAIR

University of Manitoba

Locations

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University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 25248797 (View on PubMed)

Hui A, Back L, Ludwig S, Gardiner P, Sevenhuysen G, Dean H, Sellers E, McGavock J, Morris M, Bruce S, Murray R, Shen GX. Lifestyle intervention on diet and exercise reduced excessive gestational weight gain in pregnant women under a randomised controlled trial. BJOG. 2012 Jan;119(1):70-7. doi: 10.1111/j.1471-0528.2011.03184.x. Epub 2011 Oct 21.

Reference Type RESULT
PMID: 22017967 (View on PubMed)

Related Links

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Other Identifiers

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GRT 2006-021

Identifier Type: -

Identifier Source: org_study_id

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