CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 228 enrolled
Drug / intervention
Lifestyle Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02260518
NCT02260518N/ACompleted

Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women

University of South Carolina·interventional·Posted Oct 9, 2014·Updated Apr 28, 2021

In Brief

A clinical study evaluating Lifestyle Intervention and Standard Care for Obesity and 2 related conditions. Completed, enrolled 228 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 9, 2014
Enrollment StartJan 1, 2015
Primary CompletionNov 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 11.7 years ago

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).