Prevention of Postpartum Weight Retention in Low Income WIC Women

Tracking Information
First Submitted Date ICMJE	July 29, 2011
First Posted Date ICMJE	August 3, 2011
Last Update Posted Date	May 30, 2017
Study Start Date ICMJE	July 2011
Actual Primary Completion Date	September 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (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
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01408147 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 2, 2011)	Psychosocial measures [ Time Frame: 12 months ]; Behavioral and psychosocial variables will be measured at study entry, 6 and 12 months.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Prevention of Postpartum Weight Retention in Low Income WIC Women
Official Title ICMJE	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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Obesity
Intervention ICMJE	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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 26, 2017)	371
Original Estimated Enrollment ICMJE; (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 ICMJE	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 ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01408147
Other Study ID Numbers ICMJE	1R01DK087889-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Suzanne Phelan, California Polytechnic State University-San Luis Obispo
Study Sponsor ICMJE	California Polytechnic State University-San Luis Obispo
Collaborators ICMJE	University of North Carolina, Chapel Hill
Investigators ICMJE	Principal Investigator: Suzanne Phelan, PhD. California Polytechnic State University-San Luis Obispo
PRS Account	California Polytechnic State University-San Luis Obispo
Verification Date	May 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP