Clinical trial NCT02260518: Promoting Health in Pregnancy and Postpartum
Official title: Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Pregnancy
Overweight
Keywords: Gestational weight gain
Lifestyle intervention
Pregnancy
Postpartum
Physical activity
Nutrition
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-10-09
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* 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

Primary outcomes:
measure: Gestational weight gain in pounds
timeFrame: Delivery
Secondary outcomes:
measure: Gestational weight gain category
timeFrame: Delivery
measure: Postpartum weight retention
timeFrame: Weight retained at the 6 month postpartum visit
measure: Postpartum weight retention
timeFrame: Weight retained at the 12 month postpartum visit
measure: Physical Activity
timeFrame: 32 weeks gestation
measure: Physical Activity
timeFrame: 6 months postpartum
measure: Physical Activity
timeFrame: 12 months postpartum
measure: Dietary intake
timeFrame: 32 weeks gestation
measure: Dietary intake
timeFrame: 6 months postpartum
measure: Dietary intake
timeFrame: 12 months postpartum
measure: Depressive Symptoms
timeFrame: 32 weeks gestation
measure: Depressive Symptoms
timeFrame: 6 months postpartum
measure: Depressive Symptoms
timeFrame: 12 months postpartum
measure: Health-Related Quality of Life
timeFrame: 32 weeks gestation
measure: Health-Related Quality of Life
timeFrame: 6 months postpartum
measure: Health-Related Quality of Life
timeFrame: 12 months postpartum
measure: Child Adiposity
timeFrame: 6 months postpartum
measure: Child Adiposity
timeFrame: 12 months postpartum
Other outcomes:
measure: Self-efficacy for diet and physical activity
timeFrame: 32 weeks gestation
measure: Self-efficacy for diet and physical activity
timeFrame: 6 months postpartum
measure: Self-efficacy for diet and physical activity
timeFrame: 12 months postpartum
measure: Social support for diet and physical activity
timeFrame: 32 weeks gestation
measure: Social support for diet and physical activity
timeFrame: 6 months postpartum
measure: Social support for diet and physical activity
timeFrame: 12 months postpartum
measure: Decisional balance for diet and physical activity
timeFrame: 32 weeks gestation
measure: Decisional balance for diet and physical activity
timeFrame: 6 months postpartum
measure: Decisional balance for diet and physical activity
timeFrame: 12 months postpartum
measure: Self-regulation for diet and physical activity
timeFrame: 32 weeks gestation
measure: Self-regulation for diet and physical activity
timeFrame: 6 months postpartum
measure: Self-regulation for diet and physical activity
timeFrame: 12 months postpartum
Locations:
city: Columbia
country: United States
facility: University of South Carolina Prevention Research Center
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Sara Wilcox, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Carolina
name: Jihong Liu, Sc.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilcox S, Dahl AA, Boutte AK, Liu J, Day K, Turner-McGrievy G, Wingard E. Process evaluation methods and results from the Health in Pregnancy and Postpartum (HIPP) randomized controlled trial. BMC Pregnancy Childbirth. 2022 Oct 26;22(1):794. doi: 10.1186/s12884-022-05107-x.
citation: Liu J, Wilcox S, Hutto B, Turner-McGrievy G, Wingard E. Effects of a lifestyle intervention on postpartum weight retention among women with elevated weight. Obesity (Silver Spring). 2022 Jul;30(7):1370-1379. doi: 10.1002/oby.23449. Epub 2022 Jun 20.
citation: Liu J, Wilcox S, Wingard E, Burgis J, Schneider L, Dahl A. Strategies and Challenges in Recruiting Pregnant Women with Elevated Body Mass Index for a Behavioral Lifestyle Intervention. Womens Health Rep (New Rochelle). 2020 Dec 7;1(1):556-565. doi: 10.1089/whr.2020.0089. eCollection 2020.