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

(PH Trial)

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

406 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Project Health, Response and Attention Training for obesity?

Research on similar treatments, like acceptance and commitment therapy (ACT), shows that it can help people with obesity by improving psychological flexibility and supporting behavior change, which are important for managing weight. Additionally, dissonance-based interventions have been studied for their potential to improve quality of life and physical activity, which are relevant for obesity prevention. ^{1 2 3 4 5}

Is the Dissonance-Based Obesity Prevention + Response and Attention Training safe for humans?

The studies suggest that the training is generally safe, with high adherence rates and positive feedback from participants. No significant adverse effects were reported, indicating it is well-tolerated by participants. ^{3 6 7 8 9}

How does the Project Health treatment for obesity differ from other treatments?

Project Health is unique because it combines dissonance-based obesity prevention with response and attention training, focusing on reducing the brain's reward and attention response to high-calorie foods. This approach is different from traditional treatments as it does not rely heavily on self-control and is easy and inexpensive to deliver, potentially making it more accessible and sustainable for long-term obesity management. ^{7 10 11 12 13}

What is the purpose of this trial?

This project seeks to improve the effectiveness of a novel dissonance-based obesity prevention program that has reduced future BMI gain and overweight/obesity onset by (a) experimentally testing whether implementing it in single- versus mixed-sex groups, which should increase dissonance-induction that contributes to weight gain prevention effects, and (b) experimentally testing whether adding food response and attention training, which theoretically reduces valuation of and attention for high-calorie foods, increases weight gain prevention effects. This randomized trial would be the first to experimentally manipulate these two factors in an effort to produce superior weight gain prevention effects. A brief effective obesity prevention program that can be easily, inexpensively, and broadly implemented to late adolescents at risk for excess weight gain, as has been the case with another dissonance-based prevention program, could markedly reduce the prevalence of obesity and associated morbidity and mortality.

Research Team

Eric M Stice, Ph.D.

Principal Investigator

Oregon Research Institute

Eligibility Criteria

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

I have been diagnosed with anorexia nervosa.

Current diagnosis of binge eating disorder

Current diagnosis of bulimia nervosa

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Design for a cohort-randomized trial of an acceptance and commitment therapy-enhanced weight management and fitness program for Navy personnel. [2020]

2. England pubmed.ncbi.nlm.nih.gov

A dissonance-based intervention for women post roux-en-Y gastric bypass surgery aiming at improving quality of life and physical activity 24 months after surgery: study protocol for a randomized controlled trial. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Moderation of Mood in the Transfer of Self-Regulation From an Exercise to an Eating Context: Short- and Long-Term Effects on Dietary Change and Obesity in Women. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

The role of avoidance-based coping in the psychosocial functioning of weight loss treatment-seeking adults. [2021]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Training response inhibition to food is associated with weight loss and reduced energy intake. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Pilot test of a novel food response and attention training treatment for obesity: Brain imaging data suggest actions shape valuation. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of an approach-avoidance training intervention for children and adolescents with obesity: A randomized placebo-controlled prospective trial. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

A pilot randomized trial of a cognitive reappraisal obesity prevention program. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Smartphone-based cognitive bias modification training improves healthy food choice in obesity: A pilot study. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Managing temptation in obesity treatment: A neurobehavioral model of intervention strategies. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Keeping track of promised rewards: Obesity predicts enhanced flexibility when learning from observation. [2019]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Enhanced Go and NoGo Learning in Individuals With Obesity. [2020]