Fit Moms- an Internet-based Postpartum Weight Loss Program

Early Phase 1

Completed

• Conditions: Postpartum Weight
• Interventions: Behavioral: Enhanced WIC Program

• Registration Number: NCT01096888
• Lead Sponsor: California Polytechnic State University-San Luis Obispo

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.

Study Timeline

• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Study Start: 2010-06
• Primary Completion: 2010-09
• Study Completion: 2010-11
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced WIC weight loss program	Enhanced WIC 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.

Primary Outcome Measures

Name	Time	Method
Enhanced WIC program to instigate weight loss	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 Outcome Measures

Name	Time	Method
Baseline characteristics that moderate the efficacy of the intervention.	3 months	To examine the relationship between changes in behaviors, psychosocial factors, and weight changes during the 3-month period.

Trial Locations

Locations (1)

California Polytechnic State University; 🇺🇸 San Luis Obispo, California, United States