Project Health: Enhancing Effectiveness of an Obesity Prevention Program

Not Applicable

• Conditions: Eating Disorders; Overweight and Obesity
• Interventions: Behavioral: Project Health; Other: The Weight of the Nation; Behavioral: Response and Attention Training

• Registration Number: NCT06067763
• Lead Sponsor: Oregon Research Institute

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).

Study Timeline

• Study Start: 2020-01-30
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 238

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Male Group, Food Response Training	Response and Attention Training	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.
Female Group, Food Response Training	Response and Attention Training	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.
Female Group, Food Response Training	Project Health	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.
Male Group, Food Response Training	Project Health	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.
Educational Video control	The Weight of the Nation	Participants in this arm will be assigned to watch a four-part documentary "The Weight of the Nation" from their home.

Primary Outcome Measures

Name	Time	Method
Body Fat	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 Outcome Measures

Name	Time	Method
Eating Disorder Symptoms	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.

Trial Locations

Locations (2)

Stanford University; 🇺🇸 Stanford, California, United States

Oregon Research Institute; 🇺🇸 Springfield, Oregon, United States