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Prevention of Postpartum Weight Retention in Low Income WIC Women
This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01408147
First received: July 29, 2011
Last updated: May 26, 2017
Last verified: May 2017
| Tracking Information | ||||
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| First Received Date ICMJE | July 29, 2011 | |||
| Last Updated Date | May 26, 2017 | |||
| Start Date ICMJE | July 2011 | |||
| 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 at study entry, 6 months, and 12 months. Weight is the primary outcome |
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| 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 |
Psychosocial measures [ Time Frame: 12 months ] Behavioral and psychosocial variables will be measured at study entry, 6 and 12 months. |
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| 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 Provided | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
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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 | |||
| Enrollment ICMJE | 371 | |||
| Completion Date | December 2016 | |||
| 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 |
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| 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 |
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| PRS Account | California Polytechnic State University-San Luis Obispo | |||
| Verification Date | May 2017 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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