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Clinical Trials/NCT01096888
NCT01096888
Completed
Early Phase 1

FFit Moms- an Internet-based Postpartum Weight Loss Program

California Polytechnic State University-San Luis Obispo1 site in 1 country25 target enrollmentJune 2010

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Postpartum Weight
Sponsor
California Polytechnic State University-San Luis Obispo
Enrollment
25
Locations
1
Primary Endpoint
Enhanced WIC program to instigate weight loss
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
November 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
California Polytechnic State University-San Luis Obispo
Responsible Party
Principal Investigator
Principal Investigator

Suzanne Phelan

Principal Investigator

California Polytechnic State University-San Luis Obispo

Eligibility 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.

Outcomes

Primary Outcomes

Enhanced WIC program to instigate weight loss

Time Frame: 3 months

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 Outcomes

  • Baseline characteristics that moderate the efficacy of the intervention.(3 months)

Study Sites (1)

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