A Dissonance-Based Obesity Intervention
Primary Purpose
Obesity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Project Health
Sponsored by

About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Neuropsychiatric Institute, University of Illinoist at Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dissonance-based obesity intervention
Assessment Only
Arm Description
Participants in this arm will receive Enhanced Project Health.
Participants in this arm will only complete the baseline assessment and 2 month assessment. They will not receive Enhanced Project Health.
Outcomes
Primary Outcome Measures
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.
Time for recruitment
This will be defined as time (weeks and days) from initial contact with research staff to randomization into the study.
Attendance rate of participants
This will be defined as the percentage of participants attending 75% of the group sessions.
Retention rate of participants
This will be defined as the percentage of participants remaining in the study at the post-intervention assessment.
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.
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.
Secondary Outcome Measures
Body Mass Index (kg/m^2)
Body Mass Index will be calculated using measured weight and height (kg/m^2)
International Physical Activity Questionnaire-Short Form (IPAQ-S)
The International Physical Activity Questionnaire-Short Form will assess walking, moderate-intensity activity, and vigorous-intensity activity. The scores for each type of physical activity are converted to MET-minutes/week as defined by the following: Walking MET-minutes/week = 3.3 * walking minutes * walking days; Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days; Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days; Total physical activity MET-minutes/week = sum of Walking + Moderate + Vigorous MET-minutes/week scores. The total score will be computed by summing the duration (in minutes) and frequency (days) of each activity. Higher duration and frequency indicate more engagement in physical activity. The pattern of physical activity can also be classified as low, moderate, or high based on the total score.
Actigraph GT3XP-BTLE
An accelerometer will record physical activity for a 1 week period
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index will assess the quality and patterns of sleep using a scale ranging from 0 to 3. Total scores range from 8 to 57. Higher scores indicate greater sleep disturbances.
Full Information
NCT ID
NCT04068493
First Posted
August 22, 2019
Last Updated
June 2, 2022
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT04068493
Brief Title
A Dissonance-Based Obesity Intervention
Official Title
Enhanced Project Health: A Dissonance-Based Intervention for Obesity in Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Principal investigator is transitioning to a new faculty position at another institution.
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
February 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be blind to the condition that participants are assigned to.
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dissonance-based obesity intervention
Arm Type
Experimental
Arm Description
Participants in this arm will receive Enhanced Project Health.
Arm Title
Assessment Only
Arm Type
No Intervention
Arm Description
Participants in this arm will only complete the baseline assessment and 2 month assessment. They will not receive Enhanced Project Health.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Project Health
Intervention Description
A dissonance-based obesity intervention consisting of eight weekly groups sessions (1.5 hours).
Primary Outcome Measure Information:
Title
Percentage of eligible young adults that agree to participate in the study
Description
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.
Time Frame
Up to 1 month
Title
Time for recruitment
Description
This will be defined as time (weeks and days) from initial contact with research staff to randomization into the study.
Time Frame
Up to 1 month
Title
Attendance rate of participants
Description
This will be defined as the percentage of participants attending 75% of the group sessions.
Time Frame
Assessed at 2 months
Title
Retention rate of participants
Description
This will be defined as the percentage of participants remaining in the study at the post-intervention assessment.
Time Frame
Assessed at 2 months
Title
Program Evaluation Questionnaire - Each Group Session
Description
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.
Time Frame
Assessed from week 1 to week 8
Title
Program Evaluation Questionnaire - Overall Program
Description
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.
Time Frame
Assessed at week 8
Secondary Outcome Measure Information:
Title
Body Mass Index (kg/m^2)
Description
Body Mass Index will be calculated using measured weight and height (kg/m^2)
Time Frame
Baseline to 2 months
Title
International Physical Activity Questionnaire-Short Form (IPAQ-S)
Description
The International Physical Activity Questionnaire-Short Form will assess walking, moderate-intensity activity, and vigorous-intensity activity. The scores for each type of physical activity are converted to MET-minutes/week as defined by the following: Walking MET-minutes/week = 3.3 * walking minutes * walking days; Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days; Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days; Total physical activity MET-minutes/week = sum of Walking + Moderate + Vigorous MET-minutes/week scores. The total score will be computed by summing the duration (in minutes) and frequency (days) of each activity. Higher duration and frequency indicate more engagement in physical activity. The pattern of physical activity can also be classified as low, moderate, or high based on the total score.
Time Frame
Baseline to 2 months
Title
Actigraph GT3XP-BTLE
Description
An accelerometer will record physical activity for a 1 week period
Time Frame
Baseline to 2 months
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The Pittsburgh Sleep Quality Index will assess the quality and patterns of sleep using a scale ranging from 0 to 3. Total scores range from 8 to 57. Higher scores indicate greater sleep disturbances.
Time Frame
Baseline to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvia Herbozo, Ph.D.
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuropsychiatric Institute, University of Illinoist at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606012
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Dissonance-Based Obesity Intervention
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