Postpartum Weight Retention

NCT ID: NCT02867631

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Enhanced control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes

Group Type: EXPERIMENTAL

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

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

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

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Robert Wood Johnson Foundation

OTHER

Sponsor Role: collaborator

Aetna, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Charmaine Smith Wright

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charmaine Wright, MD MSHP

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Maternity Care Coalition

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29370795 (View on PubMed)

Other Identifiers

815827

Identifier Type: -

Identifier Source: org_study_id