Study Stopped
Principal investigator is transitioning to a new faculty position at another institution.
A Dissonance-Based Obesity Intervention
Enhanced Project Health: A Dissonance-Based Intervention for Obesity in Young Adults
1 other identifier
interventional
7
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Sep 2021
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2022
CompletedJune 6, 2022
June 1, 2022
6 months
August 22, 2019
June 2, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
Percentage of eligible young adults that agree to participate in the study
This will be defined as a percentage of young adults that agree to participate in study out of the young adults screened for the study.
Up to 1 month
Time for recruitment
This will be defined as time (weeks and days) from initial contact with research staff to randomization into the study.
Up to 1 month
Attendance rate of participants
This will be defined as the percentage of participants attending 75% of the group sessions.
Assessed at 2 months
Retention rate of participants
This will be defined as the percentage of participants remaining in the study at the post-intervention assessment.
Assessed at 2 months
Program Evaluation Questionnaire - Each Group Session
This questionnaire was developed for this study. It will assess the acceptability of the intervention and will be administered at the end of each group session. Participants will be asked to rate the usefulness of the session on one item with a scale ranging from 1 to 5. Total scores range from 1 to 5. Higher scores indicate more usefulness. Participants will also be asked to respond to open-ended questions about each group session. These questions will assess the most favorable aspects, least favorable aspects, and areas of improvements. Responses will be coded using a variation of the long table approach emphasizing frequency, specificity, emotion, and extensiveness. Codes will be examined to identify themes.
Assessed from week 1 to week 8
Program Evaluation Questionnaire - Overall Program
This questionnaire was developed for this study. It will assess the program with regard to effectiveness and satisfaction as well as characteristics of the group leaders (clarity, knowledge, experience, respect) using a scale ranging from 1 to 5. Total scores range from 8 to 40. Higher scores indicate more favorable responses. This questionnaire will be administered at the end of the last group session.
Assessed at week 8
Secondary Outcomes (4)
Body Mass Index (kg/m^2)
Baseline to 2 months
International Physical Activity Questionnaire-Short Form (IPAQ-S)
Baseline to 2 months
Actigraph GT3XP-BTLE
Baseline to 2 months
Pittsburgh Sleep Quality Index (PSQI)
Baseline to 2 months
Study Arms (2)
Dissonance-based obesity intervention
EXPERIMENTALParticipants in this arm will receive Enhanced Project Health.
Assessment Only
NO INTERVENTIONParticipants in this arm will only complete the baseline assessment and 2 month assessment. They will not receive Enhanced Project Health.
Interventions
A dissonance-based obesity intervention consisting of eight weekly groups sessions (1.5 hours).
Eligibility Criteria
You may qualify if:
- Young adults of ages 18 to 25.
- Enrolled as a college student.
- Body mass index of 25 or more (overweight/obese) based on measured height and weight.
You may not qualify if:
- Diagnosis of bulimia nervosa according to DSM-5 criteria.
- Diagnosis of obstructive sleep apnea.
- Participation in interventions for weight loss or disordered eating behaviors.
- Current use of prescription drugs for weight loss or disordered eating behaviors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neuropsychiatric Institute, University of Illinoist at Chicago
Chicago, Illinois, 606012, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvia Herbozo, Ph.D.
University of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessor will be blind to the condition that participants are assigned to.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 22, 2019
First Posted
August 28, 2019
Study Start
September 1, 2021
Primary Completion
February 18, 2022
Study Completion
February 18, 2022
Last Updated
June 6, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share