Overweight and ObesityNCT06067763
Project Health: Enhancing Effectiveness of an Obesity Prevention Program
A study testing Project Health, Response and Attention Training and The Weight of the Nation in people with Overweight and Obesity and Eating Disorders, run by Oregon Research Institute at 2 sites in United States.
Trial summary
This 2-site effectiveness trial will test whether a brief dissonance-based obesity prevention program delivered in single sex groups combined with food response and attention training will produce significantly larger weight gain prevention effects than an educational video control condition. 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, Eating Disorders
- What is being tested?
- Project Health, Response and Attention Training and The Weight of the Nation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2020to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 (defined as a response of 4 or above on an 8 point scale ranging from none (0) to extreme (8))
- Self-reported room for improvement in diet and exercise habits (response of yes to "Do you believe there is room for improvement in your diet and exercise habits?" in the pre-screening questionnaire)
- BMI greater than or equal to 20 and less than or equal to 30
- Age between 17 and 20 years old
Who cannot join
- Current diagnosis of anorexia nervosa, bulimia nervosa or binge eating disorder
- Previous participation in a Project Health study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Oregon Research Institute
Springfield, Oregon, 97477
Stanford University
Stanford, California, 94305
About this study
Official title: Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program: Randomized Controlled Trial
This 2-site effectiveness trial will test whether a brief dissonance-based obesity prevention program delivered in single sex groups combined with food response and attention training will produce significantly larger weight gain prevention effects than an educational video control condition. An effectiveness trial is important to test whether this program reduces risk for unhealthy weight gain when delivered by real world clinicians under ecologically valid conditions, which is an important step toward broad implementation. A secondary aim focuses on eating disorder symptom prevention effects. A sample of 17-20 year olds with weight concerns (N = 120) will be randomized to single sex Project Health groups with food response and attention training or an educational video control condition. Participants will complete assessments at baseline, posttest, and 6- and 12-month follow ups.
Read the detailed description
In the previous Project Health trial, the investigators found Project Health is most effective when implemented in single sex groups paired with food specific response and attention training. This project will evaluate the effectiveness of this version of the Project Health intervention compared to a video control condition and is an important step toward dissemination. 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. The program may also have an important secondary benefit of preventing the onset of future eating symptoms and disorders. The study has 2 aims: (1) Test the hypothesis that Project Health implemented in single-sex groups and paired with food response inhibition and attention training produces significantly larger weight gain and overweight/obesity onset prevention effects than an educational video control condition (primary outcome). (2) Test the hypothesis that Project Health implemented in single-sex groups and paired with food response inhibition and attention training produces significantly larger eating disorder symptom prevention effects than an educational video control condition (secondary outcome).
- Conditions
- Overweight and Obesity, Eating Disorders
- Being tested
- Project Health, Response and Attention Training, The Weight of the Nation
- Keywords
- obesity, overweight, eating disorders, prevention, adolescent, dissonance
- Medical subject headings
- Overweight, Obesity, Feeding and Eating Disorders
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.
The Weight of the NationOther
This 2012 documentary discusses the facts and myths about obesity and the impacts of obesity on individuals and the health care system in the United States.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
| 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 |
| Educational Video control | Active comparator | Participants in this arm will be assigned to watch a four-part documentary "The Weight of the Nation" from their home. Receives: Other: The Weight of the Nation |
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 as measured by air displacement plethysmography (ADP) via the Bod Pod.
Measured: baseline, posttest (approximately 8 weeks after baseline), 6-month follow-up (approximately 34 weeks after baseline), 12-month follow-up (approximately 60 weeks after baseline)
Secondary outcomes (1)
Eating Disorder Symptoms
The Eating Disorder Diagnostic Interview, a brief semi-structured interview will assess eating disorder symptoms. It provides diagnoses for anorexia nervosa, bulimia nervosa, and binge eating disorder. It also provides a continuous measure of overall eating disorder symptoms.
Measured: baseline, posttest (approximately 8 weeks later), 6-month follow-up (approximately 34 weeks after baseline), 12-month follow-up (approximately 60 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start30 Jan 2020
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Drexel University
- Responsible party
- Sponsor
- Investigators
- Eric Stice, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067763
- Sponsor's protocol ID
- HD093598
- Status last verified
- Nov 2024
- First submitted
- 22 Sep 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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.
Publications
Stice E, Rohde P, Gau JM, Shaw H. A Randomized Effectiveness Trial of a Dissonance-Based Dual Obesity and Eating Disorder Prevention Program. Diabetes Obes Metab. 2026 Jul;28(7):6034-6044. doi: 10.1111/dom.70775. Epub 2026 Apr 24.
PubMed 42028623
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 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: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06067763
- Acronym / sponsor ID
- HD093598
- Conditions
- Overweight and Obesity, Eating Disorders
- Keywords
- obesity, overweight, eating disorders, prevention, adolescent, dissonance
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- Stanford University, Drexel University
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 5 Oct 2023 (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 2-site effectiveness trial will test whether a brief dissonance-based obesity prevention program delivered in single sex groups combined with food response and attention training will produce significantly larger weight gain prevention effects than an educational video control condition. An effectiveness trial is important to test whether this program reduces risk for unhealthy weight gain when delivered by real world clinicians under ecologically valid conditions, which is an important step toward broad implementation. A secondary aim focuses on eating disorder symptom prevention effects. A sample of 17-20 year olds with weight concerns (N = 120) will be randomized to single sex Project Health groups with food response and attention training or an educational video control condition. Participants will complete assessments at baseline, posttest, and 6- and 12-month follow ups.
Detailed description
In the previous Project Health trial, the investigators found Project Health is most effective when implemented in single sex groups paired with food specific response and attention training. This project will evaluate the effectiveness of this version of the Project Health intervention compared to a video control condition and is an important step toward dissemination. 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. The program may also have an important secondary benefit of preventing the onset of future eating symptoms and disorders. The study has 2 aims: (1) Test the hypothesis that Project Health implemented in single-sex groups and paired with food response inhibition and attention training produces significantly larger weight gain and overweight/obesity onset prevention effects than an educational video control condition (primary outcome). (2) Test the hypothesis that Project Health implemented in single-sex groups and paired with food response inhibition and attention training produces significantly larger eating disorder symptom prevention effects than an educational video control condition (secondary outcome).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
| Educational Video control | Active comparator | Other: The Weight of the NationParticipants in this arm will be assigned to watch a four-part documentary "The Weight of the Nation" from their home. |
Who may qualify
- Ages
- 17 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Current at least moderate weight concerns (defined as a response of 4 or above on an 8 point scale ranging from none (0) to extreme (8))
- Self-reported room for improvement in diet and exercise habits (response of yes to "Do you believe there is room for improvement in your diet and exercise habits?" in the pre-screening questionnaire)
- BMI greater than or equal to 20 and less than or equal to 30
- Age between 17 and 20 years old
Key exclusion criteria (2 listed)
- Current diagnosis of anorexia nervosa, bulimia nervosa or binge eating disorder
- Previous participation in a Project Health study
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, Male Group, Food 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, Male Group, Food Response Training |
| The Weight of the NationThis 2012 documentary discusses the facts and myths about obesity and the impacts of obesity on individuals and the health care system in the United States. | Other | Educational Video control |
Primary outcome
Body Fat
Time frame: baseline, posttest (approximately 8 weeks after baseline), 6-month follow-up (approximately 34 weeks after baseline), 12-month follow-up (approximately 60 weeks after baseline)
Change in percentage of body fat as measured by air displacement plethysmography (ADP) via the Bod Pod.
1 secondary outcome
Eating Disorder Symptoms
Time frame: baseline, posttest (approximately 8 weeks later), 6-month follow-up (approximately 34 weeks after baseline), 12-month follow-up (approximately 60 weeks after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 42028623Stice E, Rohde P, Gau JM, Shaw H. A Randomized Effectiveness Trial of a Dissonance-Based Dual Obesity and Eating Disorder Prevention Program. Diabetes Obes Metab. 2026 Jul;28(7):6034-6044. doi: 10.1111/dom.70775. Epub 2026 Apr 24.
- 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.
Eric Stice, PhD principal investigator
Stanford University
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, Response and Attention Training and The Weight of the Nation in people with Overweight and Obesity and Eating Disorders, 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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 21 Nov 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?
This study is still under way. Results are not available in the source record yet.
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, posttest (approximately 8 weeks after baseline), 6-month follow-up (approximately 34 weeks after baseline), 12-month follow-up (approximately 60 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06067763, which also lists 1 linked publication.
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 21 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.