Impact of Diet and Exercise Activity on Pregnancy Outcomes

NCT00486629 | Active Not Recruiting DMC

• 1 other identifier: GRT 2006-021
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Gestational Diabetes; Type 2 Diabetes

Keywords

Exercise; Diet; Pregnancy; Obesity; Macrosomia

Outcome Measures

Primary Outcomes (1)

• Excessive weight gain during pregnancy

  2007-2023

Secondary Outcomes (1)

• macrosomia, requirement of delivery procedures

  2007-2025

Study Arms (2)

Intervention

EXPERIMENTAL

Lifestyle intervention

Behavioral: Exercise and dietary education

Control

NO INTERVENTION

No intervention

Interventions

Exercise and dietary education 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy \< 20 weeks.
• Expressed interest in study and willingness to consent to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• The Lawson Foundation: collaborator
• Public Health Agency of Canada (PHAC): collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Related Publications (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 Sep 24;14:331. doi: 10.1186/1471-2393-14-331.

  PMID: 25248797 RESULT

• 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.

  PMID: 22017967 RESULT

MeSH Terms

Conditions

Obesity; Diabetes, Gestational; Diabetes Mellitus, Type 2; Motor Activity

Interventions

Exercise; Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Garry Shen, MD PhD

  University of Manitoba

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Lifestyle questionnaire on mothers and offspring. Tests on glucose tolerance and epigenetic analysis in offspring.

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 14, 2007
• Study Start: July 1, 2004
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)