Overview

This trial is active, not recruiting.

Conditions obesity, hypertension, depression
Treatment 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
Sponsor University of Pennsylvania
Collaborator Robert Wood Johnson Foundation
Start date January 2014
End date December 2016
Trial size 175 participants
Trial identifier NCT02867631, 815827

Summary

The Postpartum Weight Management Study is a true community-academic collaboration, bringing together Maternity Care Coalition (MCC) staff and the investigator, Dr. Charmaine Smith Wright from the University of Pennsylvania to address the needs of postpartum moms. The project is an innovative intervention to help moms lose weight after the birth of their baby. Helping mothers control their weight during pregnancy and beyond can help both mother and baby avoid later obesity and cardiovascular disease. Although all women are at risk for retaining the weight gained during pregnancy, this problem is amplified for low-income, minority women. The holistic approach aims to prevent postpartum weight retention and increase breastfeeding duration with a multi-component, low-cost intervention that provides: 1) Motivational appeals delivered in text message format; 2) Environmental aides, such as a baby carrier to combine exercise with infant care, and a pedometer to accurately measure exercise at home; 3) Enhanced peer support, including home visits and group classes with other mothers; and 4) Task-oriented professional support from nutrition and lactation experts, who assist women in developing a personalized health plan. The effectiveness of the intervention will be evaluated using a randomized control methodology among clients of MCC.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
Regular care as provided by the community based organization from which the convenience sample is recruited with one year of assessments only
(Experimental)
6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes

Primary Outcomes

Measure
Postpartum weight change
time frame: Baseline and 1 year post intervention

Secondary Outcomes

Measure
Postpartum weight change
time frame: Baseline and 6 months post intervention start
Depression
time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Dietary quality
time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention
Infant growth
time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Nutrition knowledge score change
time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Waist circumference as continuous measure, in inches
time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Back to prepregnancy weight
time frame: baseline and 1 year post intervention
Back to pregnancy weight, continuous
time frame: baseline and 1 year postpartum

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - All women who speak English, and are within six weeks of delivering a live, term, single infants Exclusion Criteria: - Women who have multiple births or preterm (<38 weeks gestation) infants

Additional Information

Official title A Randomized Controlled Trial (RCT) of an Intervention to Combat Postpartum Weight Retention
Principal investigator Charmaine Wright, MD MSHP
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.