Promoting Health in Pregnancy and Postpartum

University of South Carolina228 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

228

Conditions

Obesity Pregnancy Overweight

Interventions

Lifestyle InterventionBEHAVIORAL

During pregnancy, participants complete one face-to-face counseling session, receive 10 behavioral podcasts, and receive weekly phone calls until delivery. Participants will be asked to attend one group session on breastfeeding. Participants will have the opportunity to participate in a private Facebook group during pregnancy and postpartum. During postpartum, participants complete one face-to-face counseling session, receive 16 behavioral podcasts, receive brief weekly check-in telephone calls for six weeks, and receive up to 8 telephone counseling calls through 6 months after delivery.

Standard CareBEHAVIORAL

Women will receive standard nutrition counseling provided by physicians, nurses, nutritionists, and counselors from the Women, Infants, and Children (WIC) program (if applicable). They will receive a monthly study mailing that is educational in nature as well as podcasts related to a healthy pregnancy. During pregnancy, the mailings will focus on tips for a healthy pregnancy and on fetal development. During postpartum the mailings will focus on infant development and parenting. We will select a matched number of podcasts from Pea in the Podcast, commercially available podcasts. All mailings and podcasts will avoid discussion of weight, PA, or diet (except for foods to avoid in pregnancy for safety reasons).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of South Carolina Prevention Research Center

Columbia, South Carolina, United States

Outcomes

Primary Outcomes

Gestational weight gain in pounds

Defined as delivery room weight minus pre-pregnancy weight

Time frame: Delivery

Secondary Outcomes

Gestational weight gain category

Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive

Time frame: Delivery

Postpartum weight retention

Defined as weight during 6 month postpartum visit minus pre-pregnancy weight

Time frame: Weight retained at the 6 month postpartum visit

Postpartum weight retention

Defined as weight during 12 month postpartum visit minus pre-pregnancy weight

Time frame: Weight retained at the 12 month postpartum visit

Physical Activity

Sense Wear Armband and self-report measure will assess physical activity

Time frame: 32 weeks gestation

Physical Activity

Sense Wear Armband and self-report measure will assess physical activity

Time frame: 6 months postpartum

Physical Activity

Sense Wear Armband and self-report measure will assess physical activity

Time frame: 12 months postpartum

Dietary intake

Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.

Data from ClinicalTrials.gov

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