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

March 30, 2010
December 2, 2010
June 2010
September 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01096888 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Fit Moms- an Internet-based Postpartum Weight Loss Program
FFit Moms- an Internet-based Postpartum Weight Loss Program

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.

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Postpartum Weight
Behavioral: Enhanced WIC Program
Applying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum.
  • 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.
    Intervention: Behavioral: Enhanced WIC Program
  • 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.
    Intervention: Behavioral: Enhanced WIC Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2010
September 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01096888
CP-FM
No
Dr. Suzanne Phelan, California Polytechnic State University
California Polytechnic State University-San Luis Obispo
Women Infants and Children program WIC
Principal Investigator: Suzanne Phelan, PhD. California Polytechnic State University-San Luis Obispo
California Polytechnic State University-San Luis Obispo
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP