Prevention of Postpartum Weight Retention in Low Income WIC Women
1 other identifier
interventional
371
1 country
2
Brief Summary
This study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the WIC program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jul 2011
Longer than P75 for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 29, 2011
CompletedFirst Posted
Study publicly available on registry
August 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
September 16, 2020
CompletedSeptember 16, 2020
August 1, 2020
5.2 years
July 29, 2011
June 28, 2018
August 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight
Women randomized to the weight loss group will be assessed over time at study entry, 6 months, and 12 months. The primary outcome is change from entry to the endpoint at 12 months.
12 months
Secondary Outcomes (1)
Calorie Intake
12 months
Study Arms (2)
Treatment Group
ACTIVE COMPARATORThis group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.
Standard WIC care
NO INTERVENTIONThe control group will received Standard Care as provided through WIC.
Interventions
The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.
Eligibility Criteria
You may qualify if:
- Women
- Age 18-40 years.
- Delivery within 6-52 weeks
- Exceed pre-pregnancy weight by at least 4.5 kg (10 pounds) or current body mass index (BMI) \>/= 25
- Current BMI \> 22
- English or Spanish speaking
- Has internet access at home or a landline
- Literacy of at least 5th grade reading level
- Has a cell phone
You may not qualify if:
- Pregnant or planning to become pregnant
- Relocating in the next year
- Serious psychological problems (untreated depression, schizophrenia, bipolar disorder) or medical problem (i.e. heart disease, cancer, renal disease and diabetes), for which physician supervision of diet and exercise prescription is needed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
California Polytechnic State University
San Luis Obispo, California, 93401, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Related Publications (4)
Phelan S, Hagobian T, Brannen A, Hatley KE, Schaffner A, Munoz-Christian K, Tate DF. Effect of an Internet-Based Program on Weight Loss for Low-Income Postpartum Women: A Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2381-2391. doi: 10.1001/jama.2017.7119.
PMID: 28632867BACKGROUNDMartin CL, Tate DF, Schaffner A, Brannen A, Hatley KE, Diamond M, Munoz-Christian K, Pomeroy J, Sanchez T, Mercado A, Hagobian T, Phelan S. Acculturation Influences Postpartum Eating, Activity, and Weight Retention in Low-Income Hispanic Women. J Womens Health (Larchmt). 2017 Dec;26(12):1333-1339. doi: 10.1089/jwh.2016.6154. Epub 2017 Aug 17.
PMID: 28816589BACKGROUNDPhelan S, Brannen A, Erickson K, Diamond M, Schaffner A, Munoz-Christian K, Stewart A, Sanchez T, Rodriguez VC, Ramos DI, McClure L, Stinson C, Tate DF. 'Fit Moms/Mamas Activas' internet-based weight control program with group support to reduce postpartum weight retention in low-income women: study protocol for a randomized controlled trial. Trials. 2015 Feb 25;16:59. doi: 10.1186/s13063-015-0573-9.
PMID: 25887964RESULTBennion KA, Tate D, Munoz-Christian K, Phelan S. Impact of an Internet-Based Lifestyle Intervention on Behavioral and Psychosocial Factors During Postpartum Weight Loss. Obesity (Silver Spring). 2020 Oct;28(10):1860-1867. doi: 10.1002/oby.22921. Epub 2020 Sep 4.
PMID: 32888250DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Suzanne Phelan
- Organization
- Cal Poly
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne Phelan, PhD.
California Polytechnic State University-San Luis Obispo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor-Principal Investigator
Study Record Dates
First Submitted
July 29, 2011
First Posted
August 3, 2011
Study Start
July 1, 2011
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
September 16, 2020
Results First Posted
September 16, 2020
Record last verified: 2020-08