Postpartum Weight Retention

NCT02867631 | Completed

• 1 other identifier: 815827
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Hypertension; Depression

Keywords

Intervention study; Maternal obesity; Nutrition; Maternal child health

Outcome Measures

Primary Outcomes (1)

• Postpartum weight change

  Weight difference at one year post intervention and start of intervention

  Baseline and 1 year post intervention

Secondary Outcomes (8)

• Postpartum weight change

  Baseline and 6 months post intervention start

• Depression

  Baseline, 6 weeks, 6 months, and 1 year post intervention start

• Dietary quality

  Baseline, 6 weeks, 6 months, and 1 year post intervention

• Infant growth

  Baseline, 6 weeks, 6 months, and 1 year post intervention start

• Nutrition knowledge score change

  Baseline, 6 weeks, 6 months, and 1 year post intervention start

Study Arms (2)

Enhanced control

NO INTERVENTION

Regular care as provided by the community based organization from which the convenience sample is recruited with one year of assessments only

Intervention

EXPERIMENTAL

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

Interventions

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

Intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All women who speak English, and are within six weeks of delivering a live, term, single infants

You may not qualify if:

• Women who have multiple births or preterm (\<38 weeks gestation) infants

Sponsors & Collaborators

• University of Pennsylvania: lead
• Robert Wood Johnson Foundation: collaborator
• Aetna, Inc.: collaborator

Study Sites (1)

Maternity Care Coalition

Philadelphia, Pennsylvania, 19130, United States

Location

Related Publications (1)

• 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.

  PMID: 29370795 DERIVED

MeSH Terms

Conditions

Obesity; Hypertension; Depression; Pregnancy in Obesity

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Charmaine Wright, MD MSHP

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: August 16, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: May 30, 2019

Record last verified: 2019-05

Locations

US (1)