Dietary Interventions to Reduce Ultra-Processed Food Intake

NCT ID: NCT07226336

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-08-31

Brief Summary

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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

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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

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Ultra-Processed Food Intake Obesity & Overweight

Keywords

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Ultra-Processed Food Dietary Change Cognitive Dissonance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Introductory Educational Workshop

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Introductory Educational Workshop

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Introductory Educational Workshop

Intervention Type BEHAVIORAL

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.

Cognitive Dissonance Strategies (ON/OFF)

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Introductory Educational Workshop

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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, 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role collaborator

Oregon Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Charlotte Hagerman

Principal Investigator, Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charlotte Hagerman, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Institute

Central Contacts

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Charlotte Hagerman, PhD

Role: CONTACT

Phone: (609) 676-5816

Email: [email protected]

Other Identifiers

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5P30DK111022

Identifier Type: NIH

Identifier Source: secondary_id

View Link

31272E

Identifier Type: -

Identifier Source: org_study_id