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Project Health: Enhancing Effectiveness of an Obesity Prevention Program

Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program: Randomized Controlled Trial

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06067763
Enrollment
238
Registered
2023-10-05
Start date
2020-01-30
Completion date
2025-07-31
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorders, Overweight and Obesity

Keywords

obesity, overweight, eating disorders, prevention, adolescent, dissonance

Brief summary

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.

Detailed description

In the previous Project Health trial, the investigators found Project Health is most effective when implemented in single sex groups paired with food specific response and attention training. This project will evaluate the effectiveness of this version of the Project Health intervention compared to a video control condition and is an important step toward dissemination. 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. The program may also have an important secondary benefit of preventing the onset of future eating symptoms and disorders. The study has 2 aims: (1) Test the hypothesis that Project Health implemented in single-sex groups and paired with food response inhibition and attention training produces significantly larger weight gain and overweight/obesity onset prevention effects than an educational video control condition (primary outcome). (2) Test the hypothesis that Project Health implemented in single-sex groups and paired with food response inhibition and attention training produces significantly larger eating disorder symptom prevention effects than an educational video control condition (secondary outcome).

Interventions

BEHAVIORALProject Health

A brief dissonance-based obesity prevention program delivered in six one-hour weekly sessions.

Individualized, computerized response and attention training consisting of five separate tasks designed to increase inhibitory control to reduce overeating.

OTHERThe Weight of the Nation

This 2012 documentary discusses the facts and myths about obesity and the impacts of obesity on individuals and the health care system in the United States.

Sponsors

Stanford University
CollaboratorOTHER
Drexel University
CollaboratorOTHER
Oregon Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessors will be masked to participant condition.

Eligibility

Sex/Gender
ALL
Age
17 Years to 20 Years
Healthy volunteers
Yes

Inclusion criteria

* Current at least moderate weight concerns (defined as a response of 4 or above on an 8 point scale ranging from none (0) to extreme (8)) * Self-reported room for improvement in diet and exercise habits (response of yes to Do you believe there is room for improvement in your diet and exercise habits? in the pre-screening questionnaire) * BMI greater than or equal to 20 and less than or equal to 30 * Age between 17 and 20 years old

Exclusion criteria

* Current diagnosis of anorexia nervosa, bulimia nervosa or binge eating disorder * Previous participation in a Project Health study

Design outcomes

Primary

MeasureTime frameDescription
Body Fatbaseline, posttest (approximately 8 weeks after baseline), 6-month follow-up (approximately 34 weeks after baseline), 12-month follow-up (approximately 60 weeks after baseline)Change in percentage of body fat as measured by air displacement plethysmography (ADP) via the Bod Pod.

Secondary

MeasureTime frameDescription
Eating Disorder Symptomsbaseline, posttest (approximately 8 weeks later), 6-month follow-up (approximately 34 weeks after baseline), 12-month follow-up (approximately 60 weeks after baseline)The Eating Disorder Diagnostic Interview, a brief semi-structured interview will assess eating disorder symptoms. It provides diagnoses for anorexia nervosa, bulimia nervosa, and binge eating disorder. It also provides a continuous measure of overall eating disorder symptoms.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026