| July 29, 2011
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| August 3, 2011
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| May 30, 2017
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| July 2011
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| September 2016 (Final data collection date for primary outcome measure)
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| 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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| Same as current
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| Complete list of historical versions of study NCT01408147 on ClinicalTrials.gov Archive Site
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| Psychosocial measures [ Time Frame: 12 months ] Behavioral and psychosocial variables will be measured at study entry, 6 and 12 months.
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| Same as current
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| Not Provided
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| Not Provided
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| Prevention of Postpartum Weight Retention in Low Income WIC Women |
| Prevention of Postpartum Weight Retention in Low Income WIC Women |
| This study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the WIC program. |
| 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. |
| Interventional |
| Not Provided |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment |
| Obesity |
| 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 |
- 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.
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- 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.
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| |
| Completed |
| 371 |
| December 2016 |
| September 2016 (Final data collection date for primary outcome measure) |
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.
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| Sexes Eligible for Study: |
Female |
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| 18 Years to 40 Years (Adult) |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT01408147 |
| 1R01DK087889-01A1( U.S. NIH Grant/Contract ) |
| Yes |
| Not Provided |
| Not Provided |
| Suzanne Phelan, California Polytechnic State University-San Luis Obispo |
| California Polytechnic State University-San Luis Obispo |
| University of North Carolina, Chapel Hill |
| Principal Investigator: |
Suzanne Phelan, PhD. |
California Polytechnic State University-San Luis Obispo |
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| California Polytechnic State University-San Luis Obispo |
| May 2017 |
