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Prevention of Postpartum Weight Retention in Low Income WIC Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01408147
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Suzanne Phelan, California Polytechnic State University-San Luis Obispo

Tracking Information
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
 (submitted: August 27, 2020)
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.
Original 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
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.
Original 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.
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
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  ICMJE
  • 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 *

*   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  ICMJE 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  ICMJE
Sexes Eligible for Study: Female
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator: Suzanne Phelan, PhD. California Polytechnic State University-San Luis Obispo
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