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Enrolling by Invitation

NCT Number: NCT06067763

Project Health: Enhancing Effectiveness of an Obesity Prevention Program

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.

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Key information

Conditions

Overweight and Obesity Body Weight Eating Disorders Feeding and Eating Disorders Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

17 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Stanford, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Project Health

Behavioral

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

Response and Attention Training

Behavioral

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

The Weight of the Nation

Other

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.

Primary outcomes

  1. Body Fat

    Time frame: baseline, 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 outcomes

  1. Eating Disorder Symptoms

    Time frame: baseline, 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.

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Collaborators

  • Drexel University
  • Stanford University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2023
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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