Postpartum Weight Retention

May 28, 2019 updated by: Charmaine Smith Wright, University of Pennsylvania

A Randomized Controlled Trial (RCT) of an Intervention to Combat Postpartum Weight Retention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19130
        • Maternity Care Coalition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Enhanced control
Regular care as provided by the community based organization from which the convenience sample is recruited with one year of assessments only
Experimental: Intervention
6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum weight change
Time Frame: Baseline and 1 year post intervention
Weight difference at one year post intervention and start of intervention
Baseline and 1 year post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum weight change
Time Frame: Baseline and 6 months post intervention start
Weight difference at 6 months post intervention and start of intervention
Baseline and 6 months post intervention start
Depression
Time Frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
Using Edinburgh perinatal depression screen score, as a continuous and dichotomous (Yes/No) variable
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
Descriptive analysis of a food log from the time points proposed
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
Infant weight for length percentile at 6 weeks, 6 months, and 1 year post intervention (weight in pounds and length in inches converted to weight for length percentile using World Health Organization software support http://www.who.int/childgrowth/software/readme_stata.pdf?ua=1)
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
Using validated nutrition knowledge scale at 6 weeks, 6 months, and 1 year post intervention, difference from baseline
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
Acquired at study assessments at the proposed time points
Baseline, 6 weeks, 6 months, and 1 year post intervention start
Back to prepregnancy weight
Time Frame: baseline and 1 year post intervention
Dichotomous (yes/no) variable describing whether the subject returned to pre-pregnancy weight (difference between 1 year post and self-reported pre-pregnancy weight at baseline time point survey=0) or not
baseline and 1 year post intervention
Back to pregnancy weight, continuous
Time Frame: baseline and 1 year postpartum
Continuous (difference in 1 year post-intervention weight and self-reported pre-pregnancy weight reported at baseline time point survey) variable describing the change in weight over time
baseline and 1 year postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Aetna, Inc.
Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Charmaine Wright, MD MSHP, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 28, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 815827

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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