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Postpartum Weight Retention

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ClinicalTrials.gov Identifier: NCT02867631
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
Aetna, Inc.
Information provided by (Responsible Party):
Charmaine Smith Wright, University of Pennsylvania

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
Obesity Hypertension Depression Behavioral: 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Postpartum weight change [ Time Frame: Baseline and 1 year post intervention ]
    Weight difference at one year post intervention and start of intervention


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867631


Locations
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United States, Pennsylvania
Maternity Care Coalition
Philadelphia, Pennsylvania, United States, 19130
Sponsors and Collaborators
University of Pennsylvania
Robert Wood Johnson Foundation
Aetna, Inc.
Investigators
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Principal Investigator: Charmaine Wright, MD MSHP University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Charmaine Smith Wright, Principle Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02867631     History of Changes
Other Study ID Numbers: 815827
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

Keywords provided by Charmaine Smith Wright, University of Pennsylvania:
Intervention study
Maternal obesity
Nutrition
Maternal child health

Additional relevant MeSH terms:
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Gestational Weight Gain
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms