Promoting Health in Pregnancy and Postpartum
- Conditions
- OverweightPregnancyObesity
- Interventions
- Behavioral: Lifestyle InterventionBehavioral: Standard Care
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 228
- 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
- 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
- Arm && Interventions
Group Intervention Description Lifestyle Intervention Lifestyle Intervention The intervention will focus on women gaining the recommended amount of weight, increasing physical activity to 150 minutes per week, and meeting healthy eating guidelines. Standard Care Standard Care Women in the standard care group will attend their regularly scheduled obstetric (OB) visits with their prenatal care providers and will receive monthly mailings and matched number of podcasts.
- 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 Health-Related Quality of Life 12 months postpartum The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.
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
Trial Locations
- Locations (1)
University of South Carolina Prevention Research Center
🇺🇸Columbia, South Carolina, United States