ClinicalTrials.gg
CompletedNCT07226336DISRUPTUpdated Oct 15, 2026

Dietary Interventions to Reduce Ultra-Processed Food Intake

A Phase 2 interventional study of Introductory Educational Workshop and Standard Dietary Change (ON/OFF) in Ultra-Processed Food Intake and Obesity & Overweight, sponsored by Oregon Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Oregon Research Institute · Phase 2, Interventional, and Treatment

Updated Oct 15, 2026Now CompletedFirst site in United States+4 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Ultra-Processed Food Intake
  • Obesity & Overweight

Keywords

  • Ultra-Processed Food
  • Dietary Change
  • Cognitive Dissonance
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 59 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Oregon Research Institute is the lead sponsor of 70 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ages 18-70 years old
  • >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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Active comparator
    Active Control Condition

    Participants in this condition (Standard Dietary Change OFF, Dissonance OFF) will receive an educational workshop on UPFs and their harmful health effects.

    Behavioral: Introductory Educational Workshop

  • Experimental
    Standard Dietary Change Strategies

    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.

    Behavioral: Introductory Educational Workshop · Behavioral: Standard Dietary Change (ON/OFF)

  • Experimental
    Dissonance Strategies

    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.

    Behavioral: Introductory Educational Workshop · Behavioral: Cognitive Dissonance Strategies (ON/OFF)

  • Experimental
    Standard Dietary Change+ Dissonance Strategies

    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.

    Behavioral: Introductory Educational Workshop · Behavioral: Standard Dietary Change (ON/OFF) · Behavioral: Cognitive Dissonance Strategies (ON/OFF)

Interventions

  • BehavioralIntroductory Educational Workshop

    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.

  • BehavioralStandard 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.

  • BehavioralCognitive 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Post-Treatment (2 months)

Secondary outcomes

  1. 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.

    Time frame: Baseline, Post-Treatment (2 months)

  2. Added Sugar Intake

    Average daily added sugar intake (in grams) will be generated from participants' ASA24 recalls.

    Time frame: Baseline, Post-Treatment (2 months)

  3. Saturated Fat Intake

    Average daily saturated fat intake (in grams) will be generated from participants' ASA24 recalls.

    Time frame: Baseline; Post-Treatment (2 months)

  4. Sodium Intake

    Average daily sodium intake (in milligrams) will be generated from participants' ASA24 recalls.

    Time frame: Baseline; Post-Treatment (2 months)

  5. Fruit Intake

    Average daily fruit intake (in cups) will be generated from participants' ASA24 recalls.

    Time frame: Baseline; Post-Treatment (2 months)

  6. Vegetable Intake

    Average daily vegetable intake (in cups) will be generated from participants' ASA24 recalls.

    Time frame: Baseline; Post-Treatment (2 months)

  7. Total Calorie Intake

    Average daily calorie intake will be generated from participants' ASA24 recalls.

    Time frame: Baseline; Post-Treatment (2 months)

07

Study locations

1 site
  • Oregon Research Institute
    Springfield, Oregon 97477, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Analytic code

Time frame: IDP and supporting information will be shared within 12 months of the trial's completion, and will be stored indefinitely.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Completed
changed Oct 15, 2026
Sites
1 site added — first site in United States
Show site
  • Oregon Research Institute · Springfield, United States
Oct 15, 2026
Primary completion
Aug 2026→Jul 31, 2026 (actual)
Oct 15, 2026
Study completion
Aug 2026→Jul 31, 2026 (actual)
Oct 15, 2026
Enrollment
60 (estimated)→59 (actual)
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Not yet recruiting→Completed
    1 site added — first site in United States
    Show site
    • Oregon Research Institute · Springfield, United States
    Primary completion Aug 2026→Jul 31, 2026 (now actual)
    Study completion Aug 2026→Jul 31, 2026 (now actual)
    Enrollment 60 (estimated)→59 (actual)
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07226336
Lead sponsor
Oregon Research Institute
Responsible party
Charlotte Hagerman (Principal Investigator, Research Scientist, Oregon Research Institute) — Principal investigator
First posted
Nov 10, 2025
Start date
Feb 10, 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026
Last update
Oct 15, 2026

Study contacts

Charlotte Hagerman, PhD
principal investigator · Oregon Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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