Postpartum Weight Retention
Primary Purpose
Obesity, Hypertension, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Intervention study, Maternal obesity, Nutrition, Maternal child health
Eligibility 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
Sites / Locations
- Maternity Care Coalition
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Enhanced control
Intervention
Arm Description
Regular care as provided by the community based organization from which the convenience sample is recruited with one year of assessments only
6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
Outcomes
Primary Outcome Measures
Postpartum weight change
Weight difference at one year post intervention and start of intervention
Secondary Outcome Measures
Postpartum weight change
Weight difference at 6 months post intervention and start of intervention
Depression
Using Edinburgh perinatal depression screen score, as a continuous and dichotomous (Yes/No) variable
Dietary quality
Descriptive analysis of a food log from the time points proposed
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)
Nutrition knowledge score change
Using validated nutrition knowledge scale at 6 weeks, 6 months, and 1 year post intervention, difference from baseline
Waist circumference as continuous measure, in inches
Acquired at study assessments at the proposed time points
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
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
Full Information
NCT ID
NCT02867631
First Posted
May 29, 2015
Last Updated
May 28, 2019
Sponsor
University of Pennsylvania
Collaborators
Robert Wood Johnson Foundation, Aetna, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02867631
Brief Title
Postpartum Weight Retention
Official Title
A Randomized Controlled Trial (RCT) of an Intervention to Combat Postpartum Weight Retention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Robert Wood Johnson Foundation, Aetna, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypertension, Depression
Keywords
Intervention study, Maternal obesity, Nutrition, Maternal child health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced control
Arm Type
No Intervention
Arm Description
Regular care as provided by the community based organization from which the convenience sample is recruited with one year of assessments only
Arm Title
Intervention
Arm Type
Experimental
Arm Description
6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
Intervention Type
Behavioral
Intervention Name(s)
6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
Intervention Description
6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
Primary Outcome Measure Information:
Title
Postpartum weight change
Description
Weight difference at one year post intervention and start of intervention
Time Frame
Baseline and 1 year post intervention
Secondary Outcome Measure Information:
Title
Postpartum weight change
Description
Weight difference at 6 months post intervention and start of intervention
Time Frame
Baseline and 6 months post intervention start
Title
Depression
Description
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
Title
Dietary quality
Description
Descriptive analysis of a food log from the time points proposed
Time Frame
Baseline, 6 weeks, 6 months, and 1 year post intervention
Title
Infant growth
Description
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
Title
Nutrition knowledge score change
Description
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
Title
Waist circumference as continuous measure, in inches
Description
Acquired at study assessments at the proposed time points
Time Frame
Baseline, 6 weeks, 6 months, and 1 year post intervention start
Title
Back to prepregnancy weight
Description
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
Title
Back to pregnancy weight, continuous
Description
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
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charmaine Wright, MD MSHP
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternity Care Coalition
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19130
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29370795
Citation
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.
Results Reference
derived
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Postpartum Weight Retention
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