Prevention of Postpartum Weight Retention in Low Income WIC Women

• ClinicalTrials.gov Identifier: NCT01408147
• Recruitment Status: Completed
• First Posted: August 3, 2011
• Results First Posted: September 16, 2020
• Last Update Posted: September 16, 2020
• Sponsor: California Polytechnic State University-San Luis Obispo
• Collaborator: University of North Carolina, Chapel Hill
• Information provided by (Responsible Party): Suzanne Phelan, California Polytechnic State University-San Luis Obispo

Tracking Information

• First Submitted Date: July 29, 2011
• First Posted Date: August 3, 2011
• Results First Submitted Date: June 28, 2018
• Results First Posted Date: September 16, 2020
• Last Update Posted Date: September 16, 2020
• Study Start Date: July 2011
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 27, 2020)

Weight [ Time Frame: 12 months ]

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.

Original Primary Outcome Measures (submitted: August 2, 2011)

Weight [ Time Frame: 12 months ]

Women randomized to the weight loss group will be assessed at study entry, 6 months, and 12 months. Weight is the primary outcome

Current Secondary Outcome Measures (submitted: August 27, 2020)

Calorie Intake [ Time Frame: 12 months ]

Calorie intake was measured over time at study entry, 6 and 12 months. The primary outcome is change from entry to 12 months.

Original Secondary Outcome Measures (submitted: August 2, 2011)

Psychosocial measures [ Time Frame: 12 months ]

Behavioral and psychosocial variables will be measured at study entry, 6 and 12 months.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevention of Postpartum Weight Retention in Low Income WIC Women
• Official Title: Prevention of Postpartum Weight Retention in Low Income WIC Women
• 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.
• Detailed Description: This program is designed to reduce postpartum weight retention in low income women in the WIC program. The weight loss program will be delivered over the internet and will use behavioral weight loss techniques.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Obesity

Intervention

Behavioral: Online postpartum weight control

The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.

Other Name: Internet-based treatment for weight loss

Study Arms

• Active Comparator: Treatment Group
  This 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.
  Intervention: Behavioral: Online postpartum weight control
• No Intervention: Standard WIC care
  The control group will received Standard Care as provided through WIC.

Publications *

• Phelan S, Hagobian T, Brannen A, Hatley KE, Schaffner A, Muñoz-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.
• Martin 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.
• Phelan S, Brannen A, Erickson K, Diamond M, Schaffner A, Muñoz-Christian K, Stewart A, Sanchez T, Rodriguez VC, Ramos DI, McClure L, Stinson C, Tate DF. 'Fit Moms/Mamás 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.
• Bennion KA, Tate D, Muñoz-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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 26, 2017): 371
• Original Estimated Enrollment (submitted: August 2, 2011): 430
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01408147
• Other Study ID Numbers: 1R01DK087889-01A1( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Suzanne Phelan, California Polytechnic State University-San Luis Obispo
• Study Sponsor: California Polytechnic State University-San Luis Obispo
• Collaborators: University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Suzanne Phelan, PhD.; California Polytechnic State University-San Luis Obispo

• PRS Account: California Polytechnic State University-San Luis Obispo
• Verification Date: August 2020