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Fit Moms- an Internet-based Postpartum Weight Loss Program (FM)

This study has been completed.
Sponsor:
Collaborator:
Women Infants and Children program WIC
Information provided by:
California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier:
NCT01096888
First received: March 30, 2010
Last updated: December 2, 2010
Last verified: March 2010
History of Changes
  Purpose

The purpose of this study is to provide weight loss interventions for Mothers participating in the WIC program, using the internet to deliver weight loss materials.


Condition Intervention Phase
Postpartum Weight
 Behavioral: Enhanced WIC Program
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: FFit Moms- an Internet-based Postpartum Weight Loss Program

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Enhanced WIC program to instigate weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    We are taking the standard WIC care for Mothers who are at least 6 months post partum and enhancing their program to include an internet based weight loss intervention.


Secondary Outcome Measures:
  • Baseline characteristics that moderate the efficacy of the intervention. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To examine the relationship between changes in behaviors, psychosocial factors, and weight changes during the 3-month period.


Estimated Enrollment: 30
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard WIC care
Patients randomized to this group will receive standard WIC care and an information packet surround healthy eating and activity topics.
 Behavioral: Enhanced WIC Program
Applying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum.
Active Comparator: Enhanced WIC weight loss program
Participants randomized into this condition will receive standard WIC care, but will also receive weight loss classes provided through the internet. Topics will cover behavioral weight loss topics, based off the protocols of the Look AHEAD program.
 Behavioral: Enhanced WIC Program
Applying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum.

Detailed Description:

Develop recruitment methods and determine feasibility of recruiting WIC postpartum women who meet inclusion criteria. We will collect data on number of individuals screened and reasons for exclusions. Establish and examine feasibility and effectiveness of protocol for WIC counselors reinforcing adherence to web based program. We will assess frequency with which WIC counselors adhere to protocol of reinforcing adherence to web-based program and extent to which any "treatment contamination" occurs between WIC counselors and Standard Care participants.In those randomized to Enhanced WIC + Internet-based postpartum program, examine acceptability, burden, ease of use, frequency of technical problems, and adherence to web-based program (number of logins, message board postings)Explore whether the Enhanced WIC plus Internet postpartum weight loss program will produce significantly greater weight losses than Standard WIC at 2 months. Explore whether Enhanced WIC plus Internet postpartum weight loss program will result in greater improvements in eating and exercise behaviors (examined at 0, and 2 months) and psychosocial parameters (i.e., depression, social support, self-efficacy, body image) than standard care.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-35 years.
  • Delivery within 6-52 weeks
  • Exceed pre-pregnancy weight by at least 6.8 kg (15 pounds)
  • Current BMI > 22
  • English speaking
  • Has computer with internet access
  • Literacy of at least 5th grade reading level

Exclusion Criteria:

  • Pregnant or planning to become pregnant
  • Relocating in the next year
  • Serious 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096888

Locations
United States, California
California Polytechnic State University
San Luis Obispo, California, United States, 93407
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
Women Infants and Children program WIC
Investigators
Principal Investigator: Suzanne Phelan, PhD. California Polytechnic State University-San Luis Obispo
  More Information

No publications provided

Responsible Party: Dr. Suzanne Phelan, California Polytechnic State University
ClinicalTrials.gov Identifier: NCT01096888     History of Changes
Other Study ID Numbers: CP-FM
Study First Received: March 30, 2010
Last Updated: December 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by California Polytechnic State University-San Luis Obispo:
WIC
Weight loss
Overweight
Post Partum
Internet based weight loss intervention for Mothers in the WIC program.

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013