Status:
COMPLETED
Promoting Health in Pregnancy and Postpartum
Lead Sponsor:
University of South Carolina
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Obesity
Pregnancy
Eligibility:
FEMALE
18-44 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the impact of a lifestyle intervention on gestational weight gain, postpartum weight loss, and other secondary outcomes relative to a usual care control group.
Detailed Description
Our study will address the following specific aims: (1) examine the impact of a lifestyle intervention on gestational weight gain and postpartum weight loss in overweight and obese women, (2) examine ...
Eligibility Criteria
Inclusion
- White or African American woman
- Overweight or obese (prepregnancy BMI: 25-45 kg/m2)
- ≤ 16 wks gestation at screening
- Age 18-44 years
- No plan to move out of the greater Columbia area in next 18 months
- Regular and consistent telephone access
- Availability for telephone calls
- Willing to accept random assignment
Exclusion
- Uncontrolled hypertension
- Fetal anomaly
- Taking insulin for diabetes
- Uncontrolled or untreated thyroid disease
- Mental health or substance-abuse hospitalization in last 6 months
- Multiple gestation
- Persistent bleeding in the first trimester
- History of more than 3 miscarriages
- History of an eating disorder or current eating disorder
- History of an incompetent cervix
- Physical disability that prevents exercise
- Told by health care provider not to exercise
- Any other medical conditions that might be a contraindication to exercise or dietary change
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT02260518
Start Date
January 1 2015
End Date
November 1 2020
Last Update
April 28 2021
Active Locations (1)
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1
University of South Carolina Prevention Research Center
Columbia, South Carolina, United States, 29208