Fit Moms- an Internet-based Postpartum Weight Loss Program

NCT ID: NCT01096888

Last Updated: 2015-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-11-30

Brief Summary

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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

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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.

Conditions

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Postpartum Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard WIC care

Patients randomized to this group will receive standard WIC care and an information packet surround healthy eating and activity topics.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Enhanced WIC Program

Intervention Type BEHAVIORAL

Applying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum.

Interventions

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Enhanced WIC Program

Applying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Women Infants and Children program WIC

UNKNOWN

Sponsor Role collaborator

California Polytechnic State University-San Luis Obispo

OTHER

Sponsor Role lead

Responsible Party

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Suzanne Phelan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzanne Phelan, PhD.

Role: PRINCIPAL_INVESTIGATOR

California Polytechnic State University-San Luis Obispo

Locations

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California Polytechnic State University

San Luis Obispo, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP-FM

Identifier Type: -

Identifier Source: org_study_id

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