Dissonance-Based Program for Obesity Prevention

(PHPhase2 Trial)

Enrolling by invitation at 1 trial location

Overseen By Kathryn Madden

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Research Institute

Disqualifiers: Anorexia, Bulimia, Binge eating, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program designed to prevent unhealthy weight gain through group sessions and food-related attention training. The goal is to determine if this approach, known as Project Health, proves more effective than watching educational videos. The trial also examines whether these methods can prevent eating disorder symptoms. Ideal participants are 17- to 20-year-olds concerned about their weight and interested in improving their diet and exercise habits. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future health interventions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this program is safe for preventing obesity?

In a previous study called Project Health, which is part of this trial, the program reduced the risk of obesity by 50% in a similar initiative named Fit4Duty. This suggests the program can effectively help prevent weight gain. Although specific safety data for Project Health is unavailable, its design aims to help people maintain a healthy weight, indicating it is likely safe.

For the food response and attention training, research shows no specific safety concerns. This method helps people respond better to food cues, promoting healthier eating habits. While detailed safety data for this method is lacking, such training is generally considered low-risk.

Overall, as this is an effectiveness trial, the treatments are tested in real-world settings, implying they are considered safe enough for wider use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dissonance-Based Program for Obesity Prevention because it explores a novel approach to tackling obesity by focusing on mindset and behavior rather than just diet or exercise alone. Unlike other treatments that often emphasize dietary restrictions or physical activity, Project Health integrates food-focused response and attention training, helping participants reshape their relationship with food. This method could potentially lead to more sustainable, long-term changes in eating habits. Additionally, by tailoring sessions to gender-specific groups, the program aims to address unique psychological and social factors that may influence obesity differently in males and females.

What evidence suggests that this trial's treatments could be effective for obesity prevention?

Studies have shown that the Project Health program can be effective. Late adolescents who participated in Project Health experienced smaller increases in their BMI (Body Mass Index) and were 41% to 43% less likely to become overweight or obese over a two-year period. In this trial, participants in the "Female Group, Food Response Training" and "Male Group, Food Response Training" arms will receive Project Health and complete the food-focused response and attention training intervention. This training helps people lose weight by making high-calorie foods less tempting and improving control over eating urges. This approach reduces the attraction to unhealthy foods and strengthens the ability to resist them. Together, these treatments aim to effectively prevent unhealthy weight gain. ^{6 7 8 9 10}

Who Is on the Research Team?

Eric Stice, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for 17-20 year olds who are concerned about their weight, believe they can improve their diet and exercise habits, and have a BMI between 20 to 30. It's not for those with anorexia, bulimia, binge eating disorder or past participants in Project Health studies.

Inclusion Criteria

I believe my diet and exercise habits could be better.

I am between 17 and 20 years old.

You possess at least moderate weight-related concerns (as indicated by a rating of 4 or higher on an 8 point scale ranging from nil to extreme).

Exclusion Criteria

I have been diagnosed with an eating disorder.

Previous participation in a Project Health study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Project Health intervention in single-sex groups with food response and attention training or watch an educational video control

8 weeks

Weekly sessions

Posttest Assessment

Participants complete assessments to evaluate changes in body fat and eating disorder symptoms

1 week

6-month Follow-up

Participants are monitored for changes in body fat and eating disorder symptoms

26 weeks

1 visit (in-person)

12-month Follow-up

Participants are monitored for long-term changes in body fat and eating disorder symptoms

26 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Project Health
• Response and Attention Training

Trial Overview The study tests if a dissonance-based obesity prevention program combined with food response training beats an educational video at preventing weight gain. Participants will be randomly placed into groups and followed up over a year.

How Is the Trial Designed?

Group I: Male Group, Food Response Training Experimental Treatment 2 Interventions

Participants in this arm will be assigned to receive Project Health in male-only groups and will complete the food-focused response and attention training intervention.

Group II: Female Group, Food Response Training Experimental Treatment 2 Interventions

Participants in this arm will be assigned to receive Project Health in female-only groups and will complete the food-focused response and attention training intervention.

Group III: Educational Video control Active Control 1 Intervention

Participants in this arm will be assigned to watch a four-part documentary "The Weight of the Nation" from their home.

Who Is Running the Clinical Trial?

Oregon Research Institute

Lead Sponsor

Trials

87

Recruited

62,600+

Drexel University

Collaborator

Trials

160

Recruited

48,600+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Adherence to lifestyle-based health interventions, especially for weight loss and management, is a major challenge, with many participants struggling to maintain recommended behavior changes over the long term.

Strategies to improve long-term adherence include providing extended care, skills training, enhancing social support, and specific tactics for maintaining dietary and physical activity changes, which can help make these interventions more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Adherence to Health Behavior Change. Middleton, KR., Anton, SD., Perri, MG.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03710746

Project Health: Enhancing Effectiveness of a Dissonance ... Late adolescents randomized to Project Health showed fewer increases in BMI and a 41% and 43% reduction in overweight/obesity onset over 2-yr follow-up compared ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK612636/

Evidence review for effectiveness and acceptability of weight ... During the development of the protocol, change in BMI, BMI z-score and weight were identified as critical outcomes. Out of these outcomes, BMI z-score was ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442030104X

Integrating an online weight management program with ... Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001221

Implementation of Obesity Science Into Clinical Practice The limited availability of cost-effectiveness and health outcomes data for obesity treatment relates to additional challenges in clinician ...

5. cdc.gov cdc.gov/pcd/issues/2024/23_0347.htm

Weight Loss in Short-Term Interventions for Physical ... Short-term multicomponent interventions involving physical activity and nutrition can achieve weight loss for adults with overweight or obesity.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02679937

Prevention of Obesity in Military Communities - Fit4Duty The Fit4Duty program is an adaptation for the military of an existing civilian obesity prevention program, Project Health, which reduced obesity onset by 50% in ...

7. nifa.usda.gov nifa.usda.gov/grants/programs/obesity-prevention-healthy-weight-programs

Obesity Prevention and Healthy Weight Programs The obesity prevention projects include: identifying nutritional needs; developing new foods to help achieve caloric balance; providing nutrition education.

8. odphp.health.gov odphp.health.gov/healthypeople/objectives-and-data/browse-objectives/overweight-and-obesity

Overweight and Obesity - Healthy People 2030 Healthy People 2030 includes objectives focused on helping people eat healthy and get enough physical activity to reach and maintain a healthy weight.

9. doh.wa.gov doh.wa.gov/sites/default/files/legacy/Documents/1000/ChildhoodObesityDP.pdf?uid=6439b32de78d4

final - Washington State Department of Health The project identifies opportunities work together using proven best practices, creates obesity prevention toolkits, and reports to the governor and legislature ...

10. prevention.nih.gov prevention.nih.gov/research-priorities/obesity

Obesity | Prevention Research | ODP NIH obesity research examines trends and data about causes and outcomes of obesity and explores the implementation of promising prevention strategies.