ObesityNCT04068493
A Dissonance-Based Obesity Intervention
A study testing Enhanced Project Health in people with Obesity, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Enhanced Project Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 18 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuropsychiatric Institute, University of Illinoist at Chicago
Chicago, Illinois, 606012
About this study
Official title: Enhanced Project Health: A Dissonance-Based Intervention for Obesity in Young Adults
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Enhanced Project Health
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Project HealthBehavioural
A dissonance-based obesity intervention consisting of eight weekly groups sessions (1.5 hours).
| Study group | Role | What they receive |
|---|---|---|
| Dissonance-based obesity intervention | Experimental | Participants in this arm will receive Enhanced Project Health. Receives: Behavioral: Enhanced Project Health |
| Assessment Only | No intervention | Participants in this arm will only complete the baseline assessment and 2 month assessment. They will not receive Enhanced Project Health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 1 month
Attendance rate of participants
This will be defined as the percentage of participants attending 75% of the group sessions.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at week 8
Secondary outcomes (4)
Body Mass Index (kg/m^2)
Body Mass Index will be calculated using measured weight and height (kg/m^2)
Measured: Baseline to 2 months
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.
Measured: Baseline to 2 months
Actigraph GT3XP-BTLE
An accelerometer will record physical activity for a 1 week period
Measured: Baseline to 2 months
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.
Measured: Baseline to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Sep 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Why it stopped: Principal investigator is transitioning to a new faculty position at another institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvia Herbozo, University of Illinois Chicago
- Investigators
- Sylvia Herbozo, Ph.D., Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068493
- Sponsor's protocol ID
- 2019-0892
- Status last verified
- Jun 2022
- First submitted
- 22 Aug 2019
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Project Health: A Dissonance-Based Intervention for Obesity in Young Adults
- ClinicalTrials.gov ID
- NCT04068493
- Acronym / sponsor ID
- 2019-0892
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator is transitioning to a new faculty position at another institution.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dissonance-based obesity intervention | Experimental | Behavioral: Enhanced Project HealthParticipants in this arm will receive Enhanced Project Health. |
| Assessment Only | No intervention | –Participants in this arm will only complete the baseline assessment and 2 month assessment. They will not receive Enhanced Project Health. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Project HealthA dissonance-based obesity intervention consisting of eight weekly groups sessions (1.5 hours). | Behavioural | Dissonance-based obesity intervention |
Primary outcome
Percentage of eligible young adults that agree to participate in the study
Time frame: Up to 1 month
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
Time frame: Up to 1 month
This will be defined as time (weeks and days) from initial contact with research staff to randomization into the study.
Attendance rate of participants
Time frame: Assessed at 2 months
This will be defined as the percentage of participants attending 75% of the group sessions.
Retention rate of participants
Time frame: Assessed at 2 months
This will be defined as the percentage of participants remaining in the study at the post-intervention assessment.
Program Evaluation Questionnaire - Each Group Session
Time frame: Assessed from week 1 to week 8
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
Time frame: Assessed at week 8
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.
4 secondary outcomes
Body Mass Index (kg/m^2)
Time frame: Baseline to 2 months
International Physical Activity Questionnaire-Short Form (IPAQ-S)
Time frame: Baseline to 2 months
Actigraph GT3XP-BTLE
Time frame: Baseline to 2 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline to 2 months
Results and safety
The study was stopped early (reason given: Principal investigator is transitioning to a new faculty position at another institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia Herbozo, Ph.D. principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Project Health in people with Obesity, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal investigator is transitioning to a new faculty position at another institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eligible young adults that agree to participate in the study (time frame: Up to 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.