Dietary Interventions to Reduce Ultra-Processed Food Intake (DISRUPT)

Oregon Research Institute

Status and phase: Not yet enrolling; Phase 2

Conditions: Ultra-Processed Food Intake; Obesity & Overweight

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07226336

31272E

5P30DK111022 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Active Control Condition

Active Comparator group

Description:

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

Treatment:

Behavioral: Introductory Educational Workshop

Standard Dietary Change Strategies

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Dietary Change (ON/OFF)

Behavioral: Introductory Educational Workshop

Dissonance Strategies

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Dissonance Strategies (ON/OFF)

Behavioral: Introductory Educational Workshop

Standard Dietary Change+ Dissonance Strategies

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Dietary Change (ON/OFF)

Behavioral: Cognitive Dissonance Strategies (ON/OFF)

Behavioral: Introductory Educational Workshop