Fit Moms- an Internet-based Postpartum Weight Loss Program

Postpartum Weight Clinical Trial

— FM  

Official title:

FFit Moms- an Internet-based Postpartum Weight Loss Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096888
• Other study ID #: CP-FM
• Status: Completed
• Phase: Phase 0
• First received: March 30, 2010
• Last updated: October 26, 2015
• Start date: June 2010
• Est. completion date: November 2010

Study information

• Verified date: October 2015
• Source: California Polytechnic State University-San Luis Obispo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Weight
• Postpartum Weight
• Weight Loss

Intervention

Behavioral:
• Enhanced WIC Program
Applying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum.

Locations

Country	Name	City	State
United States	California Polytechnic State University	San Luis Obispo	California

Sponsors (2)

Lead Sponsor	Collaborator
California Polytechnic State University-San Luis Obispo	Women Infants and Children program WIC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enhanced WIC program to instigate weight loss	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.	3 months	No
Secondary	Baseline characteristics that moderate the efficacy of the intervention.	To examine the relationship between changes in behaviors, psychosocial factors, and weight changes during the 3-month period.	3 months	No