Clinical trial NCT02867631: Postpartum Weight Retention
Official title: A Randomized Controlled Trial (RCT) of an Intervention to Combat Postpartum Weight Retention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypertension
Depression
Keywords: Intervention study
Maternal obesity
Nutrition
Maternal child health
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: Aetna, Inc.
First posted: 2016-08-16
Enrollment: 175
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Postpartum weight change
timeFrame: Baseline and 1 year post intervention
Secondary outcomes:
measure: Postpartum weight change
timeFrame: Baseline and 6 months post intervention start
measure: Depression
timeFrame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
measure: Dietary quality
timeFrame: Baseline, 6 weeks, 6 months, and 1 year post intervention
measure: Infant growth
timeFrame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
measure: Nutrition knowledge score change
timeFrame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
measure: Waist circumference as continuous measure, in inches
timeFrame: Baseline, 6 weeks, 6 months, and 1 year post intervention start
measure: Back to prepregnancy weight
timeFrame: baseline and 1 year post intervention
measure: Back to pregnancy weight, continuous
timeFrame: baseline and 1 year postpartum
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Maternity Care Coalition
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Charmaine Wright, MD MSHP
role: PRINCIPAL_INVESTIGATOR
References:
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.