Postpartum Weight Retention

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867631
• Other study ID #: 815827
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: May 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Gestational Weight Gain
• Hypertension
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Maternity Care Coalition	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Aetna, Inc., Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum weight change	Weight difference at one year post intervention and start of intervention	Baseline and 1 year post intervention
Secondary	Postpartum weight change	Weight difference at 6 months post intervention and start of intervention	Baseline and 6 months post intervention start
Secondary	Depression	Using Edinburgh perinatal depression screen score, as a continuous and dichotomous (Yes/No) variable	Baseline, 6 weeks, 6 months, and 1 year post intervention start
Secondary	Dietary quality	Descriptive analysis of a food log from the time points proposed	Baseline, 6 weeks, 6 months, and 1 year post intervention
Secondary	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)	Baseline, 6 weeks, 6 months, and 1 year post intervention start
Secondary	Nutrition knowledge score change	Using validated nutrition knowledge scale at 6 weeks, 6 months, and 1 year post intervention, difference from baseline	Baseline, 6 weeks, 6 months, and 1 year post intervention start
Secondary	Waist circumference as continuous measure, in inches	Acquired at study assessments at the proposed time points	Baseline, 6 weeks, 6 months, and 1 year post intervention start
Secondary	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	baseline and 1 year post intervention
Secondary	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	baseline and 1 year postpartum