Ultra-Processed Food IntakePhase 2DISRUPTNCT07226336
Dietary Interventions to Reduce Ultra-Processed Food Intake
A Phase 2 study testing Introductory Educational Workshop, Standard Dietary Change (ON/OFF) and Cognitive Dissonance Strategies (ON/OFF) in people with Ultra-Processed Food Intake and Obesity & Overweight, run by Oregon Research Institute at 1 site in United States.
Trial summary
The DISRUPT clinical trial will test two different 2-month programs to help adults with overweight/obesity (N=60) reduce their intake of ultra-processed foods (UPFs). Participants will be randomly assigned to receive standard dietary change strategies, cognitive dissonance strategies that engage them in activism… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ultra-Processed Food Intake, Obesity & Overweight
- What is being tested?
- Introductory Educational Workshop, Standard Dietary Change (ON/OFF) and Cognitive Dissonance Strategies (ON/OFF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to 31 Jul 2026
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-70 years old
- BMI >25 and <50 kg/m2
- Wish to reduce their UPF intake
- Consume at least 2 UPF items per day and at least 4 distinct UPF items per week
Who cannot join
- Have ever been diagnosed with anorexia nervosa or bulimia nervosa
- Are using medications known to influence eating behavior and/or weight (e.g., semaglutide)
- Currently using insulin
- History of bariatric surgery
- Current pregnancy or planning to become pregnant during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Institute
Springfield, Oregon, 97477
About this study
Official title: Testing a Dissonance-Based Intervention to Reduce Ultra-Processed Food Consumption Via Activism Against the Food Industry
The DISRUPT clinical trial will test two different 2-month programs to help adults with overweight/obesity (N=60) reduce their intake of ultra-processed foods (UPFs). Participants will be randomly assigned to receive standard dietary change strategies, cognitive dissonance strategies that engage them in activism against the UPF industry, or both. All participants will attend an introductory educational workshop about UPFs. If they are assigned to receive one or more of these strategies, they will attend weekly group sessions with the relevant intervention content for 7 more weeks. Groups will be held virtually.
Read the detailed description
The DISRUPT clinical trial will test 2-month interventions for reducing ultra processed food (UPF) intake among 60 adults with overweight or obesity (ages 18-70) who frequently consume UPFs. Participants will be randomly assigned to receive a standard dietary change (SDC) intervention (ON/OFF), in which they will receive the typical toolbox of evidence-based methods for changing diet (e.g., meal planning, problem solving, reflecting on the benefits of change) to help them reduce their ultra-processed food intake. Participants will be also randomly assigned to receive a cognitive dissonance intervention (ON/OFF). In this intervention, participants will learn about the harms of the food industry and be engaged in activism against this industry to elicit cognitive dissonance for consuming UPFs. Participants will be randomly assigned to each condition separately (through a 2x2 factorial design, resulting in four possible experimental conditions: 1) Control (both OFF), 2) Standard Dietary Change Condition (SDC ON, Dissonance OFF), 3) Dissonance Condition (SDC OFF, Dissonance ON), and 4) SDC + Dissonance Condition (SDC ON, Dissonance ON).
All participants will receive an introductory educational workshop on UPFs, how to identify them, and their harmful health effects. Participants assigned to receive at least one of the interventions (i.e., SDC, dissonance, or both) will attend weekly group sessions for weeks 2-8.
Aim 1 is to test the isolated and interactive effects of standard behavior change strategies and dissonance-based strategies on treatment outcomes. Participants randomly assigned to the SDC condition and the Dissonance condition, respectively, are expected to have larger reductions in UPF intake, greater improvements in indicators of dietary quality (e.g., added sugar, sodium intake), and more weight loss, compared to those in the control condition. The effect of the SDC + Dissonance condition (vs. the control condition) on treatment outcomes is expected to be synergistic, greater than the additive effect either condition alone.
Aim 2 is to test the hypothesis that having the dissonance intervention ON will attenuate the disparity in treatment outcomes for individuals with socio-structural barriers to healthy eating (i.e., low perceived socioeconomic status, low income, limited access to healthy food, and unhealthy neighborhood food environment).
- Conditions
- Ultra-Processed Food Intake, Obesity & Overweight
- Being tested
- Introductory Educational Workshop, Standard Dietary Change (ON/OFF), Cognitive Dissonance Strategies (ON/OFF)
- Keywords
- Ultra-Processed Food, Dietary Change, Cognitive Dissonance
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introductory Educational WorkshopBehavioural
Participants will attend an introductory educational workshop held through videoconferencing software in week 1 of the program. The workshop will teach participants about ultra-processed foods (UPFs) and their negative health effects.
Standard Dietary Change (ON/OFF)Behavioural
Participants randomly assigned to have Standard Dietary Change Strategies ON will attend group sessions with a study coach, during which they will learn standard dietary change strategies such as meal planning, problem solving, and goal setting. Sessions will involve didactics, discussion, and interactive elements to promote greater participant engagement.
Cognitive Dissonance Strategies (ON/OFF)Behavioural
Participants assigned to have the dissonance condition ON will attend weekly virtual group sessions with a coach, during which they will learn about the nefarious efforts of the food industry, including its creation of UPFs to be hyperpalatable and addictive, its predatory and deceptive marketing techniques, and its role in blocking policy change. Special emphasis will be placed on the food industry's exploitation of vulnerable, low-income communities by inundating these neighborhoods with cheap, ultra-rewarding products. Participants will be asked to engage in activities designed to elicit cognitive dissonance for consuming UPFs. Examples include writing letters to Congress urging policy change and creating "elevator pitches" for family and friends.
| Study group | Role | What they receive |
|---|---|---|
| Active Control Condition | Active comparator | Participants in this condition (Standard Dietary Change OFF, Dissonance OFF) will receive an educational workshop on UPFs and their harmful health effects. Receives: Behavioral: Introductory Educational Workshop |
| Standard Dietary Change Strategies | Experimental | Participants in this condition (Standard Dietary Change ON, Dissonance OFF) will attend an introductory educational workshop about UPFs, then attend weekly group sessions that teach standard dietary change strategies for the next 7 weeks. Receives: Behavioral: Introductory Educational Workshop; Behavioral: Standard Dietary Change (ON/OFF) |
| Dissonance Strategies | Experimental | Participants in this condition (Standard Dietary Change OFF, Dissonance ON) will attend an introductory educational session about UPFs, then attend weekly group sessions in which they will be engaged in cognitive dissonance-inducing activities for the next 7 weeks. Receives: Behavioral: Introductory Educational Workshop; Behavioral: Cognitive Dissonance Strategies (ON/OFF) |
| Standard Dietary Change+ Dissonance Strategies | Experimental | Participants in this condition (Standard Dietary Change ON, Dissonance ON) will attend an introductory educational session about UPFs, then attend weekly group sessions in which they will 1) learn standard dietary change strategies and 2) be engaged in cognitive-dissonance inducing strategies for the next 7 weeks. Groups will be slightly longer to accommodate both intervention strategies. Receives: Behavioral: Introductory Educational Workshop; Behavioral: Standard Dietary Change (ON/OFF); Behavioral: Cognitive Dissonance Strategies (ON/OFF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultra-Processed Food Intake
Dietary intake will be assessed using the Automated Self-Administered 24-hour Dietary Recall (ASA24), in which participants report all of the food and beverages consumed during the past 24 hours. At each assessment, participants will complete three recalls (two weekdays, one weekend day). To calculate UPF intake, each food entry on the ASA24 will be coded into a NOVA category based on a classification system developed through a collaboration between The University de São Paulo and the National Cancer Institute. UPF intake will be operationalized as the average daily calories that come from UPFs.
Measured: Baseline, Post-Treatment (2 months)
Secondary outcomes (7)
Weight
Participants will be asked to provide their current weight by weighing themselves on three consecutive mornings on a digital scale following proper weighing procedures (e.g., in the morning, in a fasted state). The average of the three days of weights will be used.
Measured: Baseline, Post-Treatment (2 months)
Added Sugar Intake
Average daily added sugar intake (in grams) will be generated from participants' ASA24 recalls.
Measured: Baseline, Post-Treatment (2 months)
Saturated Fat Intake
Average daily saturated fat intake (in grams) will be generated from participants' ASA24 recalls.
Measured: Baseline; Post-Treatment (2 months)
Sodium Intake
Average daily sodium intake (in milligrams) will be generated from participants' ASA24 recalls.
Measured: Baseline; Post-Treatment (2 months)
Fruit Intake
Average daily fruit intake (in cups) will be generated from participants' ASA24 recalls.
Measured: Baseline; Post-Treatment (2 months)
Vegetable Intake
Average daily vegetable intake (in cups) will be generated from participants' ASA24 recalls.
Measured: Baseline; Post-Treatment (2 months)
Total Calorie Intake
Average daily calorie intake will be generated from participants' ASA24 recalls.
Measured: Baseline; Post-Treatment (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start10 Feb 2026
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
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 Ultra-Processed Food IntakeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Albert Einstein College of Medicine
- Responsible party
- Principal investigator, Charlotte Hagerman, Oregon Research Institute
- Investigators
- Charlotte Hagerman, PhD, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226336
- Sponsor's protocol ID
- 31272E
- Other IDs
- 5P30DK111022
- Acronym
- DISRUPT
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identifiable data will be de-identified prior to submission in the public repository to protect research participant privacy and confidentiality. All individual-participant level data will be preserved and shared, as all variables collected are pertinent to scientific questions.
Publications
Hagerman C, Choo-Kang D, LaFata E, Rohde P, Butryn M. A cognitive dissonance-based intervention to reduce ultra-processed food intake: Protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2026 Jun;165:108327. doi: 10.1016/j.cct.2026.108327. Epub 2026 Apr 22.
PubMed 42031230
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Dissonance-Based Intervention to Reduce Ultra-Processed Food Consumption Via Activism Against the Food Industry
- ClinicalTrials.gov ID
- NCT07226336
- Acronym / sponsor ID
- DISRUPT / 31272E
- Conditions
- Ultra-Processed Food Intake, Obesity & Overweight
- Keywords
- Ultra-Processed Food, Dietary Change, Cognitive Dissonance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Albert Einstein College of Medicine
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 10 Nov 2025 (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.
The DISRUPT clinical trial will test two different 2-month programs to help adults with overweight/obesity (N=60) reduce their intake of ultra-processed foods (UPFs). Participants will be randomly assigned to receive standard dietary change strategies, cognitive dissonance strategies that engage them in activism against the UPF industry, or both. All participants will attend an introductory educational workshop about UPFs. If they are assigned to receive one or more of these strategies, they will attend weekly group sessions with the relevant intervention content for 7 more weeks. Groups will be held virtually.
Detailed description
The DISRUPT clinical trial will test 2-month interventions for reducing ultra processed food (UPF) intake among 60 adults with overweight or obesity (ages 18-70) who frequently consume UPFs. Participants will be randomly assigned to receive a standard dietary change (SDC) intervention (ON/OFF), in which they will receive the typical toolbox of evidence-based methods for changing diet (e.g., meal planning, problem solving, reflecting on the benefits of change) to help them reduce their ultra-processed food intake. Participants will be also randomly assigned to receive a cognitive dissonance intervention (ON/OFF). In this intervention, participants will learn about the harms of the food industry and be engaged in activism against this industry to elicit cognitive dissonance for consuming UPFs. Participants will be randomly assigned to each condition separately (through a 2x2 factorial design, resulting in four possible experimental conditions: 1) Control (both OFF), 2) Standard Dietary Change Condition (SDC ON, Dissonance OFF), 3) Dissonance Condition (SDC OFF, Dissonance ON), and 4) SDC + Dissonance Condition (SDC ON, Dissonance ON).
All participants will receive an introductory educational workshop on UPFs, how to identify them, and their harmful health effects. Participants assigned to receive at least one of the interventions (i.e., SDC, dissonance, or both) will attend weekly group sessions for weeks 2-8.
Aim 1 is to test the isolated and interactive effects of standard behavior change strategies and dissonance-based strategies on treatment outcomes. Participants randomly assigned to the SDC condition and the Dissonance condition, respectively, are expected to have larger reductions in UPF intake, greater improvements in indicators of dietary quality (e.g., added sugar, sodium intake), and more weight loss, compared to those in the control condition. The effect of the SDC + Dissonance condition (vs. the control condition) on treatment outcomes is expected to be synergistic, greater than the additive effect either condition alone.
Aim 2 is to test the hypothesis that having the dissonance intervention ON will attenuate the disparity in treatment outcomes for individuals with socio-structural barriers to healthy eating (i.e., low perceived socioeconomic status, low income, limited access to healthy food, and unhealthy neighborhood food environment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Control Condition | Active comparator | Behavioral: Introductory Educational WorkshopParticipants in this condition (Standard Dietary Change OFF, Dissonance OFF) will receive an educational workshop on UPFs and their harmful health effects. |
| Standard Dietary Change Strategies | Experimental | Behavioral: Introductory Educational Workshop, Behavioral: Standard Dietary Change (ON/OFF)Participants in this condition (Standard Dietary Change ON, Dissonance OFF) will attend an introductory educational workshop about UPFs, then attend weekly group sessions that teach standard dietary change strategies for the next 7 weeks. |
| Dissonance Strategies | Experimental | Behavioral: Introductory Educational Workshop, Behavioral: Cognitive Dissonance Strategies (ON/OFF)Participants in this condition (Standard Dietary Change OFF, Dissonance ON) will attend an introductory educational session about UPFs, then attend weekly group sessions in which they will be engaged in cognitive dissonance-inducing activities for the next 7 weeks. |
| Standard Dietary Change+ Dissonance Strategies | Experimental | Behavioral: Introductory Educational Workshop, Behavioral: Standard Dietary Change (ON/OFF), Behavioral: Cognitive Dissonance Strategies (ON/OFF)Participants in this condition (Standard Dietary Change ON, Dissonance ON) will attend an introductory educational session about UPFs, then attend weekly group sessions in which they will 1) learn standard dietary change strategies and 2) be engaged in cognitive-dissonance inducing strategies for the next 7 weeks. Groups will be slightly longer to accommodate both intervention strategies. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18-70 years old
- BMI >25 and <50 kg/m2
- Wish to reduce their UPF intake
- Consume at least 2 UPF items per day and at least 4 distinct UPF items per week
Key exclusion criteria (5 listed)
- Have ever been diagnosed with anorexia nervosa or bulimia nervosa
- Are using medications known to influence eating behavior and/or weight (e.g., semaglutide)
- Currently using insulin
- History of bariatric surgery
- Current pregnancy or planning to become pregnant during the study period
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 |
|---|---|---|
| Introductory Educational WorkshopParticipants will attend an introductory educational workshop held through videoconferencing software in week 1 of the program. The workshop will teach participants about ultra-processed foods (UPFs) and their negative health effects. | Behavioural | Active Control Condition, Dissonance Strategies, Standard Dietary Change Strategies, Standard Dietary Change+ Dissonance Strategies |
| Standard Dietary Change (ON/OFF)Participants randomly assigned to have Standard Dietary Change Strategies ON will attend group sessions with a study coach, during which they will learn standard dietary change strategies such as meal planning, problem solving, and goal setting. Sessions will involve didactics, discussion, and interactive elements to promote greater participant engagement. | Behavioural | Standard Dietary Change Strategies, Standard Dietary Change+ Dissonance Strategies |
| Cognitive Dissonance Strategies (ON/OFF)Participants assigned to have the dissonance condition ON will attend weekly virtual group sessions with a coach, during which they will learn about the nefarious efforts of the food industry, including its creation of UPFs to be hyperpalatable and addictive, its predatory and deceptive marketing techniques, and its role in blocking policy change. Special emphasis will be placed on the food industry's exploitation of vulnerable, low-income communities by inundating these neighborhoods with cheap, ultra-rewarding products. Participants will be asked to engage in activities designed to elicit cognitive dissonance for consuming UPFs. Examples include writing letters to Congress urging policy change and creating "elevator pitches" for family and friends. | Behavioural | Dissonance Strategies, Standard Dietary Change+ Dissonance Strategies |
Primary outcome
Ultra-Processed Food Intake
Time frame: Baseline, Post-Treatment (2 months)
Dietary intake will be assessed using the Automated Self-Administered 24-hour Dietary Recall (ASA24), in which participants report all of the food and beverages consumed during the past 24 hours. At each assessment, participants will complete three recalls (two weekdays, one weekend day). To calculate UPF intake, each food entry on the ASA24 will be coded into a NOVA category based on a classification system developed through a collaboration between The University de São Paulo and the National Cancer Institute. UPF intake will be operationalized as the average daily calories that come from UPFs.
7 secondary outcomes
Weight
Time frame: Baseline, Post-Treatment (2 months)
Added Sugar Intake
Time frame: Baseline, Post-Treatment (2 months)
Saturated Fat Intake
Time frame: Baseline; Post-Treatment (2 months)
Sodium Intake
Time frame: Baseline; Post-Treatment (2 months)
Fruit Intake
Time frame: Baseline; Post-Treatment (2 months)
Vegetable Intake
Time frame: Baseline; Post-Treatment (2 months)
Total Calorie Intake
Time frame: Baseline; Post-Treatment (2 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Derived from this study: PubMed 42031230Hagerman C, Choo-Kang D, LaFata E, Rohde P, Butryn M. A cognitive dissonance-based intervention to reduce ultra-processed food intake: Protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2026 Jun;165:108327. doi: 10.1016/j.cct.2026.108327. Epub 2026 Apr 22.
- Individual participant dataSharing planned: Yes. Identifiable data will be de-identified prior to submission in the public repository to protect research participant privacy and confidentiality. All individual-participant level data will be preserved and shared, as all variables collected are pertinent to scientific questions.
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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.
Charlotte Hagerman, PhD principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Introductory Educational Workshop, Standard Dietary Change (ON/OFF) and Cognitive Dissonance Strategies (ON/OFF) in people with Ultra-Processed Food Intake and Obesity & Overweight, run by Oregon Research Institute 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Oct 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ultra-Processed Food Intake (time frame: Baseline, Post-Treatment (2 months)). 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 NCT07226336, 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 15 Oct 2026.