Dietary Interventions to Reduce Ultra-Processed Food Intake
- Conditions
- Ultra-Processed Food IntakeObesity & Overweight
- Registration Number
- NCT07226336
- Lead Sponsor
- Oregon Research Institute
- Brief Summary
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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Ultra-Processed Food Intake Baseline, 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.
- Secondary Outcome Measures
Name Time Method Weight Baseline, Post-Treatment (2 months) 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.
Added Sugar Intake Baseline, Post-Treatment (2 months) Average daily added sugar intake (in grams) will be generated from participants' ASA24 recalls.
Saturated Fat Intake Baseline; Post-Treatment (2 months) Average daily saturated fat intake (in grams) will be generated from participants' ASA24 recalls.
Sodium Intake Baseline; Post-Treatment (2 months) Average daily sodium intake (in milligrams) will be generated from participants' ASA24 recalls.
Fruit Intake Baseline; Post-Treatment (2 months) Average daily fruit intake (in cups) will be generated from participants' ASA24 recalls.
Vegetable Intake Baseline; Post-Treatment (2 months) Average daily vegetable intake (in cups) will be generated from participants' ASA24 recalls.
Total Calorie Intake Baseline; Post-Treatment (2 months) Average daily calorie intake will be generated from participants' ASA24 recalls.