A Dissonance-Based Obesity Intervention

NCT ID: NCT04068493

Last Updated: 2022-06-06

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

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-02-18

Brief Summary

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This project will examine the feasibility and acceptability of Enhanced Project Health, a dissonance-based obesity intervention, and whether this intervention results in significantly greater reductions in weight and improvements in lifestyle behaviors than an assessment only condition. Participants will be young adults enrolled in college.

Detailed Description

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Approximately 34% of college students are overweight/obese. However, few behavioral weight loss (BWL) interventions have been developed for young adults in college. Research suggests that standard BWL interventions are not addressing the needs of young adults as they have shown poorer retention rates and weight loss compared to older adults in BWL trials. Standard BWL interventions are also time-intensive and are not conducive to inexpensive dissemination.

The primary aim of this project is to examine the feasibility and acceptability of Enhanced Project Health, a dissonance-based obesity intervention for young adults enrolled in college. Enhanced Project Health is based on Project Health, a dissonance-based obesity prevention program, which has been shown to significantly decrease weight gain and future overweight/obesity onset compared to a matched intervention and minimal intervention control condition in young adults. The current intervention was expanded to consist of eight weekly group sessions and to address sleep, in addition to diet and physical activity. The secondary aim is to test the hypothesis that Enhanced Project Health will result in significantly greater reductions in weight and improvements in lifestyle behaviors compared to an assessment only condition.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcomes assessor will be blind to the condition that participants are assigned to.

Study Groups

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Dissonance-based obesity intervention

Participants in this arm will receive Enhanced Project Health.

Group Type EXPERIMENTAL

Enhanced Project Health

Intervention Type BEHAVIORAL

A dissonance-based obesity intervention consisting of eight weekly groups sessions (1.5 hours).

Assessment Only

Participants in this arm will only complete the baseline assessment and 2 month assessment. They will not receive Enhanced Project Health.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced Project Health

A dissonance-based obesity intervention consisting of eight weekly groups sessions (1.5 hours).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Young adults of ages 18 to 25.
2. Enrolled as a college student.
3. Body mass index of 25 or more (overweight/obese) based on measured height and weight.

Exclusion Criteria

1. Diagnosis of bulimia nervosa according to DSM-5 criteria.
2. Diagnosis of obstructive sleep apnea.
3. Participation in interventions for weight loss or disordered eating behaviors.
4. Current use of prescription drugs for weight loss or disordered eating behaviors.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Sylvia Herbozo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sylvia Herbozo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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Neuropsychiatric Institute, University of Illinoist at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2019-0892

Identifier Type: -

Identifier Source: org_study_id

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