Fit Moms- an Internet-based Postpartum Weight Loss Program (FM)

October 26, 2015 updated by: Suzanne Phelan, California Polytechnic State University-San Luis Obispo

FFit Moms- an Internet-based Postpartum Weight Loss Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Luis Obispo, California, United States, 93407
        • California Polytechnic State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard WIC care
Patients randomized to this group will receive standard WIC care and an information packet surround healthy eating and activity topics.
ACTIVE_COMPARATOR: Enhanced WIC weight loss 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.
Behavioral: Enhanced WIC Program
Applying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Polytechnic State University-San Luis Obispo

Collaborators

Women Infants and Children program WIC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

March 30, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (ESTIMATE)

March 31, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-FM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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