Fit Moms- an Internet-based Postpartum Weight Loss Program (FM)
Primary Purpose
Postpartum Weight
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Enhanced WIC Program
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Weight focused on measuring WIC, Weight loss, Overweight, Post Partum, Internet based weight loss intervention for Mothers in the WIC program.
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.
Sites / Locations
- California Polytechnic State University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard WIC care
Enhanced WIC weight loss program
Arm Description
Patients randomized to this group will receive standard WIC care and an information packet surround healthy eating and activity topics.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01096888
First Posted
March 30, 2010
Last Updated
October 26, 2015
Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
Women Infants and Children program WIC
1. Study Identification
Unique Protocol Identification Number
NCT01096888
Brief Title
Fit Moms- an Internet-based Postpartum Weight Loss Program
Acronym
FM
Official Title
FFit Moms- an Internet-based Postpartum Weight Loss Program
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
Women Infants and Children program WIC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Weight
Keywords
WIC, Weight loss, Overweight, Post Partum, Internet based weight loss intervention for Mothers in the WIC program.
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard WIC care
Arm Type
No Intervention
Arm Description
Patients randomized to this group will receive standard WIC care and an information packet surround healthy eating and activity topics.
Arm Title
Enhanced WIC weight loss program
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Enhanced WIC Program
Intervention Description
Applying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum.
Primary Outcome Measure Information:
Title
Enhanced WIC program to instigate weight loss
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Baseline characteristics that moderate the efficacy of the intervention.
Description
To examine the relationship between changes in behaviors, psychosocial factors, and weight changes during the 3-month period.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Phelan, PhD.
Organizational Affiliation
California Polytechnic State University-San Luis Obispo
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Polytechnic State University
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93407
Country
United States
12. IPD Sharing Statement
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