Postpartum Weight Retention

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT02867631
Collaborator
Robert Wood Johnson Foundation (Other), Aetna, Inc. (Industry)
175
1
2
47
3.7

Study Details

Study Description

Brief 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.
Condition or Disease Intervention/Treatment Phase
  • Behavioral: 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
175 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Randomized Controlled Trial (RCT) of an Intervention to Combat Postpartum Weight Retention
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Postpartum weight change [Baseline and 1 year post intervention]

    Weight difference at one year post intervention and start of intervention

Secondary Outcome Measures

  1. Postpartum weight change [Baseline and 6 months post intervention start]

    Weight difference at 6 months post intervention and start of intervention

  2. Depression [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

  3. Dietary quality [Baseline, 6 weeks, 6 months, and 1 year post intervention]

    Descriptive analysis of a food log from the time points proposed

  4. Infant growth [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)

  5. Nutrition knowledge score change [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

  6. Waist circumference as continuous measure, in inches [Baseline, 6 weeks, 6 months, and 1 year post intervention start]

    Acquired at study assessments at the proposed time points

  7. Back to prepregnancy weight [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

  8. Back to pregnancy weight, continuous [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maternity Care Coalition Philadelphia Pennsylvania United States 19130

Sponsors and Collaborators

  • University of Pennsylvania
  • Robert Wood Johnson Foundation
  • Aetna, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Charmaine Smith Wright, Principle Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02867631
Other Study ID Numbers:
  • 815827
First Posted:
Aug 16, 2016
Last Update Posted:
May 30, 2019
Last Verified:
May 1, 2019
Keywords provided by Charmaine Smith Wright, Principle Investigator, University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 30, 2019