We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Postpartum Weight Retention in Low Income WIC Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01408147
First Posted: August 3, 2011
Last Update Posted: May 30, 2017
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.
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Suzanne Phelan, California Polytechnic State University-San Luis Obispo
  Purpose
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 Intervention
Obesity Behavioral: Online postpartum weight control

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Suzanne Phelan, California Polytechnic State University-San Luis Obispo:

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


Enrollment: 371
Study Start Date: July 2011
Study Completion Date: December 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Suzanne Phelan, Associate Professor-Principle Investigator, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier: NCT01408147     History of Changes
Other Study ID Numbers: 1R01DK087889-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 29, 2011
First Posted: August 3, 2011
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Suzanne Phelan, California Polytechnic State University-San Luis Obispo:
Postpartum weight retention
Low income women
WIC
Online