Overweight and ObesityPHNCT03710746
Project Health: Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program
A study testing Project Health and Response and Attention Training in people with Overweight and Obesity, run by Oregon Research Institute at 2 sites in United States.
Trial summary
This project seeks to improve the effectiveness of a novel dissonance-based obesity prevention program that has reduced future BMI gain and overweight/obesity onset by (a) experimentally testing whether implementing it in single- versus mixed-sex groups, which should increase dissonance-induction that contributes to… Read more about this study
- Who is it for?
- Ages 17 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Project Health and Response and Attention Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2018to 30 Jun 2025
- 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 17 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Current at least moderate weight concerns (response of moderate, severe or extreme to the presence of weight concerns question)
- BMI between 20 and 30
Who cannot join
- Current diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Research Institute
Eugene, Oregon, 97403
Drexel University
Philadelphia, Pennsylvania, 19104
About this study
Official title: Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program
This project seeks to improve the effectiveness of a novel dissonance-based obesity prevention program that has reduced future BMI gain and overweight/obesity onset by (a) experimentally testing whether implementing it in single- versus mixed-sex groups, which should increase dissonance-induction that contributes to weight gain prevention effects, and (b) experimentally testing whether adding food response and attention training, which theoretically reduces valuation of and attention for high-calorie foods, increases weight gain prevention effects. This randomized trial would be the first to experimentally manipulate these two factors in an effort to produce superior weight gain prevention effects. A brief effective obesity prevention program that can be easily, inexpensively, and broadly implemented to late adolescents at risk for excess weight gain, as has been the case with another dissonance-based prevention program, could markedly reduce the prevalence of obesity and associated morbidity and mortality.
Read the detailed description
Prevention is key for combating obesity, but few programs have prevented future increases in BMI and onset of overweight/obesity, particularly during late adolescence when youth often assume responsibility for dietary intake and exercise choices. One exception is a brief 6-hr dissonance-based program (Project Health) wherein participants make small lasting incremental lifestyle changes to dietary intake and exercise to reach energy balance, and discuss costs of obesity, an unhealthy diet, and sedentary behavior, and benefits of leanness, a healthy diet, and exercise, which prompts them to align their attitudes with their publicly displayed behavior. These activities promote the internalization of health goals and executive control over lifestyle behaviors. Late adolescents randomized to Project Health showed fewer increases in BMI and a 41% and 43% reduction in overweight/obesity onset over 2-yr follow-up compared to a version of the program lacking dissonance induction activities and an obesity education condition. Project Health appears to be the first program to produce these key obesity prevention effects relative to an alternative intervention, but it is critical to increase effects. A dissonance-based prevention program was more effective when implemented in single- versus mixed-sex groups, theoretically, because it promoted greater participation in dissonance-inducing discussions. Aim 1a is to test whether the weight gain prevention effects will be larger when Project Health is implemented in single-sex groups; the investigators will randomize 450 17-20-year-olds to complete Project Health in female, male, or mixed-sex groups, assessing outcomes at pretest, post-test, and 6, 12, 24, and 36-month follow-ups. Aim 1b is to test whether greater participation in dissonance-inducing discussions and group cohesion mediate the effect of condition on any superior weight gain prevention effects. Adolescents who show greater functional Magnetic Resonance Imaging( fMRI)-assessed reward and attention region responsivity to food images exhibit elevated future weight gain, implying that reducing this responsivity may reduce future weight gain. In a pilot trial, late adolescents who completed go/no-go, stop-signal, and respond-signal computer training in which they repeatedly inhibit responses to high-calorie foods and respond to low-calorie foods, and dot-probe and visual-search computer tasks that train attention away from high-calorie foods and to low-calorie foods, showed a greater reduction in reward and attention region responsivity to, palatability rating of, and willingness to pay for, high-calorie foods, suggesting reduced valuation and attentional bias, as well as greater fat loss over 1-yr follow-up versus controls who completed the training with non-food images. Aim 2a is to test whether adding food response and attention training to Project Health will produce larger weight gain prevention effects. Participants in the 3 conditions will be randomized to complete response and attention training for 25-mins after each of the 6-sessions with either food or non-food images. Aim 2b is to test whether reduced palatability ratings of, willingness to pay, and attentional bias for high-calorie foods mediate the effect of training condition on any superior weight gain prevention effects.
During the Coronavirus Disease 2019 (COVID-19) shelter-at-home order, the investigators will not measure in-person only outcomes including assessments using the BodPod (a body composition tracking system using air displacement plethysmography), and height and weight measurement for BMI calculation for all participants that have assessments due during this order. The investigators will continue to conduct intervention groups that will be administered on a virtual platform.
- Conditions
- Overweight and Obesity
- Being tested
- Project Health, Response and Attention Training
- Keywords
- obesity, overweight, prevention, adolescence, dissonance
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project HealthBehavioural
A brief dissonance-based obesity prevention program delivered in six one-hour weekly sessions.
Response and Attention TrainingBehavioural
Individualized, computerized response and attention training consisting of five separate tasks designed to increase inhibitory control to reduce overeating.
| Study group | Role | What they receive |
|---|---|---|
| Mixed Group, Food Response Training | Experimental | Participants in this arm will be assigned to receive Project Health in mixed-sex groups and will complete the food-focused response and attention training intervention. Receives: Behavioral: Project Health; Behavioral: Response and Attention Training |
| Mixed Group, Generic Response Training | Experimental | Participants in this arm will be assigned to receive Project Health in mixed-sex groups and will complete the generic response and attention training intervention. Receives: Behavioral: Project Health; Behavioral: Response and Attention Training |
| Female Group, Food Response Training | Experimental | Participants in this arm will be assigned to receive Project Health in female-only groups and will complete the food-focused response and attention training intervention. Receives: Behavioral: Project Health; Behavioral: Response and Attention Training |
| Female Group, Generic Response Training | Experimental | Participants in this arm will be assigned to receive Project Health in female-only groups and will complete the generic response and attention training intervention. Receives: Behavioral: Project Health; Behavioral: Response and Attention Training |
| Male Group, Food Response Training | Experimental | Participants in this arm will be assigned to receive Project Health in male-only groups and will complete the food-focused response and attention training intervention. Receives: Behavioral: Project Health; Behavioral: Response and Attention Training |
| Male Group, Generic Response Training | Experimental | Participants in this arm will be assigned to receive Project Health in male-only groups and will complete the generic response and attention training intervention. Receives: Behavioral: Project Health; Behavioral: Response and Attention Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat
Change in percentage of body fat (Not collected during COVID-19 shelter-at-home order)
Measured: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Secondary outcomes (3)
Weight Concerns Scale from the Eating Disorder Examination Questionnaire (EDE-Q)
Change in weight concerns. Scale scores range from 0 to 42 with higher scores being indicative of higher weight concerns.
Measured: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Beck Depression Index (BDI)
Change in depressive symptoms
Measured: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Eating Disorder Interview (EDDI)
Change in eating disorder symptoms
Measured: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start8 Oct 2018
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Drexel University
- Responsible party
- Sponsor
- Investigators
- Eric M Stice, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710746
- Sponsor's protocol ID
- HD093598-01A1
- Acronym
- PH
- Status last verified
- Aug 2024
- First submitted
- 8 Oct 2018
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share all study data via the NICHD Data and Specimen Hub (DASH), which is the centralized resource for researchers to store and access data from NICHD-funded research studies to use for secondary research. All data, with the exception of video recordings of the participants in treatment (which cannot be effectively de-identified), will be provided.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program
- ClinicalTrials.gov ID
- NCT03710746
- Acronym / sponsor ID
- PH / HD093598-01A1
- Conditions
- Overweight and Obesity
- Keywords
- obesity, overweight, prevention, adolescence, dissonance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- Drexel University
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Oct 2018 (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 seeks to improve the effectiveness of a novel dissonance-based obesity prevention program that has reduced future BMI gain and overweight/obesity onset by (a) experimentally testing whether implementing it in single- versus mixed-sex groups, which should increase dissonance-induction that contributes to weight gain prevention effects, and (b) experimentally testing whether adding food response and attention training, which theoretically reduces valuation of and attention for high-calorie foods, increases weight gain prevention effects. This randomized trial would be the first to experimentally manipulate these two factors in an effort to produce superior weight gain prevention effects. A brief effective obesity prevention program that can be easily, inexpensively, and broadly implemented to late adolescents at risk for excess weight gain, as has been the case with another dissonance-based prevention program, could markedly reduce the prevalence of obesity and associated morbidity and mortality.
Detailed description
Prevention is key for combating obesity, but few programs have prevented future increases in BMI and onset of overweight/obesity, particularly during late adolescence when youth often assume responsibility for dietary intake and exercise choices. One exception is a brief 6-hr dissonance-based program (Project Health) wherein participants make small lasting incremental lifestyle changes to dietary intake and exercise to reach energy balance, and discuss costs of obesity, an unhealthy diet, and sedentary behavior, and benefits of leanness, a healthy diet, and exercise, which prompts them to align their attitudes with their publicly displayed behavior. These activities promote the internalization of health goals and executive control over lifestyle behaviors. Late adolescents randomized to Project Health showed fewer increases in BMI and a 41% and 43% reduction in overweight/obesity onset over 2-yr follow-up compared to a version of the program lacking dissonance induction activities and an obesity education condition. Project Health appears to be the first program to produce these key obesity prevention effects relative to an alternative intervention, but it is critical to increase effects. A dissonance-based prevention program was more effective when implemented in single- versus mixed-sex groups, theoretically, because it promoted greater participation in dissonance-inducing discussions. Aim 1a is to test whether the weight gain prevention effects will be larger when Project Health is implemented in single-sex groups; the investigators will randomize 450 17-20-year-olds to complete Project Health in female, male, or mixed-sex groups, assessing outcomes at pretest, post-test, and 6, 12, 24, and 36-month follow-ups. Aim 1b is to test whether greater participation in dissonance-inducing discussions and group cohesion mediate the effect of condition on any superior weight gain prevention effects. Adolescents who show greater functional Magnetic Resonance Imaging( fMRI)-assessed reward and attention region responsivity to food images exhibit elevated future weight gain, implying that reducing this responsivity may reduce future weight gain. In a pilot trial, late adolescents who completed go/no-go, stop-signal, and respond-signal computer training in which they repeatedly inhibit responses to high-calorie foods and respond to low-calorie foods, and dot-probe and visual-search computer tasks that train attention away from high-calorie foods and to low-calorie foods, showed a greater reduction in reward and attention region responsivity to, palatability rating of, and willingness to pay for, high-calorie foods, suggesting reduced valuation and attentional bias, as well as greater fat loss over 1-yr follow-up versus controls who completed the training with non-food images. Aim 2a is to test whether adding food response and attention training to Project Health will produce larger weight gain prevention effects. Participants in the 3 conditions will be randomized to complete response and attention training for 25-mins after each of the 6-sessions with either food or non-food images. Aim 2b is to test whether reduced palatability ratings of, willingness to pay, and attentional bias for high-calorie foods mediate the effect of training condition on any superior weight gain prevention effects.
During the Coronavirus Disease 2019 (COVID-19) shelter-at-home order, the investigators will not measure in-person only outcomes including assessments using the BodPod (a body composition tracking system using air displacement plethysmography), and height and weight measurement for BMI calculation for all participants that have assessments due during this order. The investigators will continue to conduct intervention groups that will be administered on a virtual platform.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Mixed Group, Food Response Training | Experimental | Behavioral: Project Health, Behavioral: Response and Attention TrainingParticipants in this arm will be assigned to receive Project Health in mixed-sex groups and will complete the food-focused response and attention training intervention. |
| Mixed Group, Generic Response Training | Experimental | Behavioral: Project Health, Behavioral: Response and Attention TrainingParticipants in this arm will be assigned to receive Project Health in mixed-sex groups and will complete the generic response and attention training intervention. |
| Female Group, Food Response Training | Experimental | Behavioral: Project Health, Behavioral: Response and Attention TrainingParticipants in this arm will be assigned to receive Project Health in female-only groups and will complete the food-focused response and attention training intervention. |
| Female Group, Generic Response Training | Experimental | Behavioral: Project Health, Behavioral: Response and Attention TrainingParticipants in this arm will be assigned to receive Project Health in female-only groups and will complete the generic response and attention training intervention. |
| Male Group, Food Response Training | Experimental | Behavioral: Project Health, Behavioral: Response and Attention TrainingParticipants in this arm will be assigned to receive Project Health in male-only groups and will complete the food-focused response and attention training intervention. |
| Male Group, Generic Response Training | Experimental | Behavioral: Project Health, Behavioral: Response and Attention TrainingParticipants in this arm will be assigned to receive Project Health in male-only groups and will complete the generic response and attention training intervention. |
Who may qualify
- Ages
- 17 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Current at least moderate weight concerns (response of moderate, severe or extreme to the presence of weight concerns question)
- BMI between 20 and 30
Key exclusion criteria (1 listed)
- Current diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder
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 |
|---|---|---|
| Project HealthA brief dissonance-based obesity prevention program delivered in six one-hour weekly sessions. | Behavioural | Female Group, Food Response Training, Female Group, Generic Response Training, Male Group, Food Response Training, Male Group, Generic Response Training, Mixed Group, Food Response Training, Mixed Group, Generic Response Training |
| Response and Attention TrainingIndividualized, computerized response and attention training consisting of five separate tasks designed to increase inhibitory control to reduce overeating. | Behavioural | Female Group, Food Response Training, Female Group, Generic Response Training, Male Group, Food Response Training, Male Group, Generic Response Training, Mixed Group, Food Response Training, Mixed Group, Generic Response Training |
Primary outcome
Body Fat
Time frame: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Change in percentage of body fat (Not collected during COVID-19 shelter-at-home order)
3 secondary outcomes
Weight Concerns Scale from the Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Beck Depression Index (BDI)
Time frame: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Eating Disorder Interview (EDDI)
Time frame: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Oregon Research Institute WebsiteLink provided by the sponsor.
- Drexel University: WELL Center WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators will share all study data via the NICHD Data and Specimen Hub (DASH), which is the centralized resource for researchers to store and access data from NICHD-funded research studies to use for secondary research. All data, with the exception of video recordings of the participants in treatment (which cannot be effectively de-identified), will be provided.
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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.
Eric M Stice, Ph.D. principal investigator
Oregon Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Health and Response and Attention Training in people with Overweight and Obesity, run by Oregon Research Institute at 2 sites 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Body Fat (time frame: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months). 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 9 Aug 2024.