Clinical trial NCT01096888: Fit Moms- an Internet-based Postpartum Weight Loss Program
Official title: FFit Moms- an Internet-based Postpartum Weight Loss Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Postpartum Weight
Keywords: WIC
Weight loss
Overweight
Post Partum
Internet based weight loss intervention for Mothers in the WIC program.
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
Collaborators: name: Women Infants and Children program WIC
First posted: 2010-03-31
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Enhanced WIC program to instigate weight loss
timeFrame: 3 months
Secondary outcomes:
measure: Baseline characteristics that moderate the efficacy of the intervention.
timeFrame: 3 months
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: California Polytechnic State University
state: California
Study officials:
affiliation: California Polytechnic State University-San Luis Obispo
name: Suzanne Phelan, PhD.
role: PRINCIPAL_INVESTIGATOR
References: