Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Prevention of Postpartum Weight Retention in Low Income WIC Women

This study is ongoing, but not recruiting participants.
Sponsor:
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: October 26, 2015
Last verified: October 2015

July 29, 2011
October 26, 2015
July 2011
September 2016   (final data collection date for primary outcome measure)
Weight [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Women randomized to the weight loss group will be assessed at study entry, 6 months, and 12 months. Weight is the primary outcome
Same as current
Complete list of historical versions of study NCT01408147 on ClinicalTrials.gov Archive Site
Psychosocial measures [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Behavioral and psychosocial variables will be measured at study entry, 6 and 12 months.
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.
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.
 
Active, not recruiting
430
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.
Female
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01408147
1R01DK087889-01A1
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
California Polytechnic State University-San Luis Obispo
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP