Dissonance-Based Obesity Prevention + Response and Attention Training for Obesity

(PH Trial)

Not currently recruiting at 1 trial location

Overseen By Eric M Stice, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Research Institute

Disqualifiers: Anorexia, bulimia, binge eating

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

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to prevent weight gain through a program called Project Health. Researchers are exploring how the program functions in different group settings, such as mixed-sex or single-sex groups, and whether adding food response training (to reduce interest in high-calorie foods) enhances its effectiveness. The program targets late adolescents with moderate weight concerns and a BMI between 20 and 30, excluding those with certain eating disorders like bulimia or anorexia. The goal is to discover an easy and effective method to help young people at risk of gaining extra weight. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could benefit many young people in the future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatment method, Project Health, effectively reduces obesity by 50% in programs like Fit4Duty, used in the military. This suggests it is generally well-tolerated. Although detailed safety data specifically for Project Health is lacking, its success in reducing obesity implies safety.

For the food response and attention training, studies have employed personalized training to help individuals focus on healthy food choices. No reports of negative effects have emerged, suggesting it might be safe. However, since these methods are new, monitoring for any unexpected reactions is advisable.

Overall, these methods have shown promise in reducing weight gain, with no major safety concerns identified in the research. As with any new approach, staying informed and reporting any side effects during the trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike most treatments for obesity that focus primarily on diet and exercise, Project Health introduces a novel approach by incorporating response and attention training. Researchers are excited about these methods because they aim to change the way participants respond to food cues and improve their attention control, which could lead to more sustainable weight management. This approach is unique in its emphasis on psychological and behavioral training, potentially offering a complementary strategy to traditional obesity treatments. By tailoring interventions to mixed-sex and single-gender groups with either food-focused or generic response training, the program also explores how group dynamics and targeted training can impact outcomes.

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

Research has shown that the Project Health program, available to participants in this trial, can help prevent weight gain and reduce obesity. In previous studies, late teens who participated in Project Health were 41% to 43% less likely to become overweight or obese over two years. This program appears to slow increases in BMI (body mass index), which is a positive sign for managing weight.

Meanwhile, studies have demonstrated that Response and Attention Training, another treatment option in this trial, aids weight loss by altering reactions to high-calorie foods. It helps individuals focus less on unhealthy foods, making them easier to resist. This training has been linked to losing body fat and gaining better control over eating habits. Both approaches show promise in managing weight and preventing obesity. ^{6 7 8 9 10}

Who Is on the Research Team?

Eric M Stice, Ph.D.

Principal Investigator

Oregon Research Institute

Are You a Good Fit for This Trial?

This trial is for late adolescents with a BMI between 20 and 30 who are moderately to extremely concerned about their weight. It's not open to individuals diagnosed with anorexia, bulimia, or binge eating disorder.

Inclusion Criteria

Current at least moderate weight concerns (response of moderate, severe or extreme to the presence of weight concerns question)

BMI between 20 and 30

Exclusion Criteria

Current diagnosis of binge eating disorder

I have been diagnosed with anorexia nervosa.

Current diagnosis of bulimia nervosa

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete Project Health sessions and response/attention training over 6 sessions

6 weeks

6 sessions (virtual during COVID-19)

Follow-up

Participants are monitored for changes in body fat, weight concerns, and depressive symptoms

38 months

Assessments at 2, 8, 14, 26, and 38 months

What Are the Treatments Tested in This Trial?

Interventions

• Project Health
• Response and Attention Training

Trial Overview The study tests a dissonance-based obesity prevention program in single- vs mixed-sex groups and adds food response and attention training. The goal is to see if these methods can prevent weight gain more effectively.

How Is the Trial Designed?

Group I: Mixed Group, Generic Response Training Experimental Treatment 2 Interventions

Participants in this arm will be assigned to receive Project Health in mixed-sex groups and will complete the generic response and attention training intervention.

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

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

Group III: Male Group, Generic 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 generic response and attention training intervention.

Group IV: 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 V: Female Group, Generic 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 generic response and attention training intervention.

Group VI: 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.

Who Is Running the Clinical Trial?

Oregon Research Institute

Lead Sponsor

Trials

87

Recruited

62,600+

Drexel University

Collaborator

Trials

160

Recruited

48,600+

Published Research Related to This Trial

A pilot study involving 60 overweight or obese participants showed that approach-avoidance training (AAT) delivered via smartphone apps effectively reduced the tendency to approach unhealthy foods and increased the choice of healthy foods.

In contrast, episodic future thinking (EFT) did not significantly impact delay discounting or food choices, suggesting that AAT is a more effective cognitive training strategy for improving food choices in obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based cognitive bias modification training improves healthy food choice in obesity: A pilot study. Kakoschke, N., Hawker, C., Castine, B., et al.[2019]

In a study of 83 predominantly overweight or obese adults, online response inhibition training targeting high-energy density foods led to significant weight loss and reduced daily energy intake compared to a control group.

Participants who underwent the active training not only lost weight but also reported a decreased liking for high-energy foods, indicating that this intervention could be an effective strategy for reducing food consumption and improving public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training response inhibition to food is associated with weight loss and reduced energy intake. Lawrence, NS., O'Sullivan, J., Parslow, D., et al.[2022]

A randomized controlled trial involving 80 participants tested Acceptance and Commitment Therapy (ACT) after bariatric surgery, but attendance was low, with only 29% of ACT participants completing more than half of the sessions.

Despite the low attendance, participants who did attend the ACT groups reported benefits such as behavior change, indicating that while the intervention was not well accepted in its current format, it has potential if delivery methods are improved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing a critical need: A randomised controlled feasibility trial of acceptance and commitment therapy for bariatric surgery patients at 15-18 months post-surgery. Barley, EA., Bovell, M., Bennett-Eastley, K., et al.[2023]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8313625/

A practical approach to obesity prevention: Healthy home ... Nurse practitioners can encourage families to participate in healthy habits by addressing areas of growth for obesity prevention within the home.