Health TrialsbyHealthPanel

Dietary Interventions to Reduce Ultra-Processed Food Intake

ConditionsUltra-Processed Food IntakeObesity & Overweight
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOregon Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Active Control ConditionActive comparator 1 intervention
Group B: Standard Dietary Change StrategiesExperimental treatment 2 interventions
Group C: Dissonance StrategiesExperimental treatment 2 interventions
Group D: Standard Dietary Change+ Dissonance StrategiesExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
Baseline, Post-Treatment (2 months)

Secondary outcomes

1

Weight

Participants will be asked to provide their current weight by weighing themselves on three consecutive mornings on a digital scale following proper weighing procedures (e.g., in the morning, in a fasted state). The average of the three days of weights will be used.

Time frame
Baseline, Post-Treatment (2 months)
2

Added Sugar Intake

Average daily added sugar intake (in grams) will be generated from participants' ASA24 recalls.

Time frame
Baseline, Post-Treatment (2 months)
3

Saturated Fat Intake

Average daily saturated fat intake (in grams) will be generated from participants' ASA24 recalls.

Time frame
Baseline; Post-Treatment (2 months)
4

Sodium Intake

Average daily sodium intake (in milligrams) will be generated from participants' ASA24 recalls.

Time frame
Baseline; Post-Treatment (2 months)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Research Institute

Lead sponsor

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

Collaborator

Albert Einstein College of Medicine

Collaborator

Source ClinicalTrials.gov

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