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Clinical Trials/NCT02260518
NCT02260518
Completed
N/A

Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women

University of South Carolina1 site in 1 country228 target enrollmentJanuary 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
University of South Carolina
Enrollment
228
Locations
1
Primary Endpoint
Gestational weight gain in pounds
Status
Completed
Last Updated
5 years ago

Overview

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 the impact of the intervention on physical activity (PA), dietary intake, and quality of life (QOL), (3) examine race differences in total gestational weight gain, PA, dietary intake, and QOL; and (4) examine the impact of the intervention on offspring adiposity.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
November 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sara Wilcox

Professor

University of South Carolina

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Outcomes

Primary Outcomes

Gestational weight gain in pounds

Time Frame: Delivery

Defined as delivery room weight minus pre-pregnancy weight

Secondary Outcomes

  • Dietary intake(12 months postpartum)
  • Depressive Symptoms(12 months postpartum)
  • Child Adiposity(12 months postpartum)
  • Gestational weight gain category(Delivery)
  • Postpartum weight retention(Weight retained at the 12 month postpartum visit)
  • Health-Related Quality of Life(12 months postpartum)
  • Physical Activity(12 months postpartum)

Study Sites (1)

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