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Postpartum Weight Retention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02867631
Enrollment
175
Registered
2016-08-16
Start date
2014-01-31
Completion date
2017-12-31
Last updated
2019-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Hypertension, Obesity

Keywords

Intervention study, Maternal obesity, Nutrition, Maternal child health

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.

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

Sponsors

Robert Wood Johnson Foundation
CollaboratorOTHER
Aetna, Inc.
CollaboratorINDUSTRY
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frameDescription
Postpartum weight changeBaseline and 1 year post interventionWeight difference at one year post intervention and start of intervention

Secondary

MeasureTime frameDescription
DepressionBaseline, 6 weeks, 6 months, and 1 year post intervention startUsing Edinburgh perinatal depression screen score, as a continuous and dichotomous (Yes/No) variable
Dietary qualityBaseline, 6 weeks, 6 months, and 1 year post interventionDescriptive analysis of a food log from the time points proposed
Infant growthBaseline, 6 weeks, 6 months, and 1 year post intervention startInfant 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)
Postpartum weight changeBaseline and 6 months post intervention startWeight difference at 6 months post intervention and start of intervention
Waist circumference as continuous measure, in inchesBaseline, 6 weeks, 6 months, and 1 year post intervention startAcquired at study assessments at the proposed time points
Back to prepregnancy weightbaseline and 1 year post interventionDichotomous (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
Back to pregnancy weight, continuousbaseline and 1 year postpartumContinuous (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
Nutrition knowledge score changeBaseline, 6 weeks, 6 months, and 1 year post intervention startUsing validated nutrition knowledge scale at 6 weeks, 6 months, and 1 year post intervention, difference from baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026