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CompletedNCT02867631Updated May 30, 2019

Postpartum Weight Retention

An interventional study of 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes in Obesity, Hypertension and Depression, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-30.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
175
Allocation
Randomized
Sex
Female
01

Study 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.

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Conditions studied

  • Obesity
  • Hypertension
  • Depression

Keywords

  • Intervention study
  • Maternal obesity
  • Nutrition
  • Maternal child health
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In context

Gestational Weight Gain

119 studies on the registry are indexed under Gestational Weight Gain; 20 are open to participants now.

This study's enrollment of 175 is above the median of 108 across 100 interventional studies indexed under Gestational Weight Gain.

Browse Gestational Weight Gain studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • Women who have multiple births or preterm (\<38 weeks gestation) infants
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
175 participants (actual)

Study arms

  • 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

Interventions

  • Behavioral6 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

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What researchers measure

Primary outcomes

  1. Postpartum weight change

    Weight difference at one year post intervention and start of intervention

    Time frame: Baseline and 1 year post intervention

Secondary outcomes

  1. Postpartum weight change

    Weight difference at 6 months post intervention and start of intervention

    Time frame: Baseline and 6 months post intervention start

  2. Depression

    Using Edinburgh perinatal depression screen score, as a continuous and dichotomous (Yes/No) variable

    Time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start

  3. Dietary quality

    Descriptive analysis of a food log from the time points proposed

    Time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention

  4. Infant growth

    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)

    Time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start

  5. Nutrition knowledge score change

    Using validated nutrition knowledge scale at 6 weeks, 6 months, and 1 year post intervention, difference from baseline

    Time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start

  6. Waist circumference as continuous measure, in inches

    Acquired at study assessments at the proposed time points

    Time frame: Baseline, 6 weeks, 6 months, and 1 year post intervention start

  7. Back to prepregnancy weight

    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

    Time frame: baseline and 1 year post intervention

  8. Back to pregnancy weight, continuous

    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

    Time frame: baseline and 1 year postpartum

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Study locations

1 site
  • Maternity Care Coalition
    Philadelphia, Pennsylvania 19130, United States
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References and documents

Publications

  • Wright C, Mogul M, Acevedo G, Aysola J, Momplaisir F, Schwartz S, Shea J. Preparing for a trial to test a postpartum weight retention intervention among low income women: feasibility of a protocol in a community-based organization. BMC Womens Health. 2018 Jan 25;18(1):27. doi: 10.1186/s12905-018-0517-0. PubMed 29370795 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02867631
Lead sponsor
University of Pennsylvania
Collaborators
Robert Wood Johnson Foundation, Aetna, Inc.
Responsible party
Charmaine Smith Wright (Principle Investigator, University of Pennsylvania) — Principal investigator
First posted
Aug 16, 2016
Start date
Jan 2014
Primary completion
Dec 2016
Completion
Dec 2017
Last update
May 30, 2019

Study contacts

Charmaine Wright, MD MSHP
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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