Promoting Health in Pregnancy and Postpartum

Not Applicable

Completed

• Conditions: Overweight; Pregnancy; Obesity

• Registration Number: NCT02260518
• Lead Sponsor: University of South Carolina

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.

Study Timeline

• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-09
• Study Start: 2015-01
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 228

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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gestational weight gain in pounds	Delivery	Defined as delivery room weight minus pre-pregnancy weight

Secondary Outcome Measures

Name	Time	Method
Dietary intake	12 months postpartum	Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.
Depressive Symptoms	12 months postpartum	Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.
Child Adiposity	12 months postpartum	Z-scores and skinfolds will be used to measure child adiposity.
Gestational weight gain category	Delivery	Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive
Postpartum weight retention	Weight retained at the 12 month postpartum visit	Defined as weight during 12 month postpartum visit minus pre-pregnancy weight
Physical Activity	12 months postpartum	Sense Wear Armband and self-report measure will assess physical activity
Health-Related Quality of Life	12 months postpartum	The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.

Trial Locations

Locations (1)

University of South Carolina Prevention Research Center; 🇺🇸 Columbia, South Carolina, United States