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Completed

NCT Number: NCT02867631

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Postpartum weight change

    Time frame: Baseline and 1 year post intervention

    Weight difference at one year post intervention and start of intervention

Secondary outcomes

  1. Postpartum weight change

    Time frame: Baseline and 6 months post intervention start

    Weight difference at 6 months post intervention and start of intervention

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Aetna, Inc.
  • Robert Wood Johnson Foundation

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Aug 16, 2016
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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