NCT07226336

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
3mo left

Started Feb 2026

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

October 31, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

October 31, 2025

Last Update Submit

November 5, 2025

Conditions

Keywords

Ultra-Processed FoodDietary ChangeCognitive Dissonance

Outcome Measures

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.

    Baseline, Post-Treatment (2 months)

Secondary Outcomes (7)

  • Weight

    Baseline, Post-Treatment (2 months)

  • Added Sugar Intake

    Baseline, Post-Treatment (2 months)

  • Saturated Fat Intake

    Baseline; Post-Treatment (2 months)

  • Sodium Intake

    Baseline; Post-Treatment (2 months)

  • Fruit Intake

    Baseline; Post-Treatment (2 months)

  • +2 more secondary outcomes

Study Arms (4)

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.

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.

Behavioral: Introductory Educational WorkshopBehavioral: 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.

Behavioral: Introductory Educational WorkshopBehavioral: 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.

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

Interventions

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.

Active Control ConditionDissonance StrategiesStandard Dietary Change StrategiesStandard Dietary Change+ Dissonance Strategies

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.

Standard Dietary Change StrategiesStandard Dietary Change+ Dissonance Strategies

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.

Dissonance StrategiesStandard Dietary Change+ Dissonance Strategies

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Charlotte Hagerman, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Hagerman, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Research Scientist

Study Record Dates

First Submitted

October 31, 2025

First Posted

November 10, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

November 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ANALYTIC CODE
Time Frame
IDP and supporting information will be shared within 12 months of the trial's completion, and will be stored indefinitely.