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Not yet recruiting NCT07226336

Dietary Interventions to Reduce Ultra-Processed Food Intake

Phase II Interventional Ultra-Processed Food Intake Obesity & Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Introductory Educational Workshop, Standard Dietary Change (ON/OFF), Cognitive Dissonance Strategies (ON/OFF).
Who it may be relevant to
Registry conditions: Ultra-Processed Food Intake, Obesity & Overweight. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Testing a Dissonance-Based Intervention to Reduce Ultra-Processed Food Consumption Via Activism Against the Food Industry

Overview

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).

Interventions

  • Behavioral Introductory 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.
  • Behavioral 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.
  • Behavioral 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

Primary outcome measures

  • Ultra-Processed Food Intake [Time frame: Baseline, Post-Treatment (2 months)]
Secondary outcome measures (7)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 42031230

Identifiers

NCT: NCT07226336 · 31272E · 5P30DK111022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗