Trial of Fresh Start Weight Loss Intervention in WIC Participants

NCT ID: NCT02176915

Last Updated: 2019-10-14

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

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2019-09-30

Brief Summary

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The Fresh Start postpartum weight loss program will test the effectiveness of a group-based weight loss intervention that includes videos featuring peers who have successfully achieved postpartum weight loss. The group-based condition will be compared to a control condition involving print materials related to weight loss.

Detailed Description

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The goal is to study the effectiveness and implementation of a postpartum weight loss intervention for WIC clients that has potential for sustainability. The investigators will compare outcomes among participants in a group-based weight loss intervention condition (Fresh Start) to outcomes among participants in a self-directed, print materials only, comparison group. The Fresh Start intervention, informed by formative research studies, consists of an 8-session group-based weight loss intervention delivered by WIC nutritionists and peer leaders. The intervention integrates key educational and skill building strategies from the lifestyle arm of the Diabetes Prevention Program with delivery strategies and messages specific for the WIC program and postpartum women. The intervention will be evaluated in a randomized clinical trial that will contribute to generalizable knowledge.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group program

8-session group weight loss program and 4 follow-up phone counseling sessions

Group Type EXPERIMENTAL

Group program

Intervention Type BEHAVIORAL

Print Materials

8 weekly mailings of print materials covering weight loss topics through US mail.

Group Type ACTIVE_COMPARATOR

Print Materials

Intervention Type BEHAVIORAL

Interventions

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Group program

Intervention Type BEHAVIORAL

Print Materials

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 6 months or less postpartum
* Speaks English
* BMI 25 or greater
* Client of WIC program, Worcester MA

Exclusion Criteria

* Not able to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Stephenie Lemon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephenie Lemon, PhD

Role: PRINCIPAL_INVESTIGATOR

UMass Worcester

Locations

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UMass Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

References

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Rosal MC, Haughton CF, Estabrook BB, Wang ML, Chiriboga G, Nguyen OH, Person SD, Lemon SC. Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial. BMC Public Health. 2016 Sep 9;16(1):953. doi: 10.1186/s12889-016-3520-0.

Reference Type DERIVED
PMID: 27612615 (View on PubMed)

Other Identifiers

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P60MD006912

Identifier Type: NIH

Identifier Source: secondary_id

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1P60MD006912

Identifier Type: NIH

Identifier Source: org_study_id

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