Prevention of Postpartum Weight Retention in Low Income WIC Women
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ClinicalTrials.gov Identifier: NCT01408147 |
Recruitment Status :
Completed
First Posted : August 3, 2011
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
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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
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Tracking Information | |||||
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First Submitted Date ICMJE | July 29, 2011 | ||||
First Posted Date ICMJE | August 3, 2011 | ||||
Results First Submitted Date ICMJE | June 28, 2018 | ||||
Results First Posted Date ICMJE | September 16, 2020 | ||||
Last Update Posted Date | September 16, 2020 | ||||
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 |
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.
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Original Primary Outcome Measures ICMJE |
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
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
Psychosocial measures [ Time Frame: 12 months ] Behavioral and psychosocial variables will be measured at study entry, 6 and 12 months.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | 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 ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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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
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
371 | ||||
Original Estimated Enrollment ICMJE |
430 | ||||
Actual Study Completion Date ICMJE | December 2016 | ||||
Actual Primary Completion Date | September 2016 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 40 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | 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 |
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IPD Sharing Statement ICMJE | 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 |
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PRS Account | California Polytechnic State University-San Luis Obispo | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |