Dissonance-Based Program for Obesity Prevention

(PHPhase2 Trial)

Recruiting 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

238 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. It is best to discuss this with the trial coordinators or your doctor.

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

Research suggests that adding coping skills training to health education and behavioral support can improve health outcomes in obesity prevention programs. Additionally, addressing barriers to behavior change and improving adherence to lifestyle interventions can enhance the effectiveness of obesity treatments. ^{1 2 3 4 5}

Is the Dissonance-Based Program for Obesity Prevention safe for humans?

The research articles provided do not contain specific safety data for the Dissonance-Based Program for Obesity Prevention or its related programs like Project Health or Response and Attention Training. ^{6 7 8 9 10}

How is the Project Health treatment for obesity prevention different from other treatments?

Project Health is unique because it uses dissonance-induction activities to make participants feel a mental conflict about unhealthy habits, encouraging them to change their behavior. This approach is different from traditional methods that focus solely on education or gradual lifestyle changes. ^{11 12 13 14 15}

What is the purpose of this trial?

This 2-site effectiveness trial will test whether a brief dissonance-based obesity prevention program delivered in single sex groups combined with food response and attention training will produce significantly larger weight gain prevention effects than an educational video control condition. An effectiveness trial is important to test whether this program reduces risk for unhealthy weight gain when delivered by real world clinicians under ecologically valid conditions, which is an important step toward broad implementation. A secondary aim focuses on eating disorder symptom prevention effects. A sample of 17-20 year olds with weight concerns (N = 120) will be randomized to single sex Project Health groups with food response and attention training or an educational video control condition. Participants will complete assessments at baseline, posttest, and 6- and 12-month follow ups.

Research Team

Eric Stice, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

An internet obesity prevention program for adolescents. [2022]

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

Stages of change and weight loss among rural African American women. [2022]

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. England pubmed.ncbi.nlm.nih.gov

Determinants of adherence to lifestyle intervention in adults with obesity: a systematic review. [2022]

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

Long-Term Adherence to Health Behavior Change. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of a screening procedure to identify potentially disruptive participants in an immersion program for the treatment of adolescent obesity. [2021]

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

Formative process evaluation for implementing a social marketing intervention to increase walking among African Americans in the Positive Action for Today's Health trial. [2022]

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

Steps in the design, development and formative evaluation of obesity prevention-related behavior change trials. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Implementation of a multilevel, multicomponent intervention for obesity control in Native American communities (OPREVENT2): challenges and lessons learned. [2022]

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

The relationship between school-level characteristics and implementation fidelity of a coordinated school health childhood obesity prevention intervention. [2019]

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

Clinician-led, peer-led, and internet-delivered dissonance-based eating disorder prevention programs: Effectiveness of these delivery modalities through 4-year follow-up. [2021]

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

A randomized trial of a dissonance-based eating disorder prevention program. [2019]

13. England pubmed.ncbi.nlm.nih.gov

An experimental therapeutics test of whether adding dissonance-induction activities improves the effectiveness of a selective obesity and eating disorder prevention program. [2019]

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

Enhancing efficacy of a dissonance-based obesity and eating disorder prevention program: Experimental therapeutics. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Effectiveness trial of a selective dissonance-based eating disorder prevention program with female college students: Effects at 2- and 3-year follow-up. [2018]