Clinical trial

Dietary Interventions to Reduce Ultra-Processed Food Intake

Opening soon · Phase 2 · 0 countries · Registry ID NCT07226336

Opening soonPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionUltra-Processed Food Intake, Obesity & Overweight

Full registry 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

Treatments and study arms

Introductory Educational Workshop

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)

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)

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.

Primary outcomes

Ultra-Processed Food IntakeBaseline, 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.

Study locations

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No public site location was included in this record. Check the original registry for updates.