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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
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Suzanne Phelan, California Polytechnic State University-San Luis Obispo

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Online postpartum weight control Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 371 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prevention of Postpartum Weight Retention in Low Income WIC Women
Study Start Date : July 2011
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

No Intervention: Standard WIC care
The control group will received Standard Care as provided through WIC.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Psychosocial measures [ Time Frame: 12 months ]
    Behavioral and psychosocial variables will be measured at study entry, 6 and 12 months.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408147


Locations
United States, California
California Polytechnic State University
San Luis Obispo, California, United States, 93401
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Suzanne Phelan, PhD. California Polytechnic State University-San Luis Obispo