Prevention of Postpartum Weight Retention in Low Income WIC Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by California Polytechnic State University-San Luis Obispo
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: July 25, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 California Polytechnic State University-San Luis Obispo:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 430
Study Start Date: July 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408147

Contacts
Contact: Suzanne Phelan, PhD 805-756-2087 sphelan@calpoly.edu
Contact: Anna Brannen, B.S 805-756-5365 acbranne@calpoly.edu

Locations
United States, California
California Polytechnic State University Recruiting
San Luis Obispo, California, United States, 93401
Contact: Anna Brannen, BS    805-756-5368    acbranne@calpoly.edu   
Principal Investigator: Suzanne Phelan, PhD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States
Contact: Deborah Tate, PhD       dtate@unc.edu   
Principal Investigator: Deborah Tate, PhD         
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

No publications provided

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: 1 RO1 DK087889-01A1
Study First Received: July 29, 2011
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014