Project Health: Enhancing Effectiveness of an Obesity Prevention Program

NCT06067763 | Enrolling By Invitation

• 1 other identifier: HD093598
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight and Obesity; Eating Disorders

Keywords

obesity; overweight; eating disorders; prevention; adolescent; dissonance

Outcome Measures

Primary Outcomes (1)

• Body Fat

  Change in percentage of body fat as measured by air displacement plethysmography (ADP) via the Bod Pod.

  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)

Secondary Outcomes (1)

• 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)

Study Arms (3)

Female Group, Food Response Training

EXPERIMENTAL

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.

Behavioral: Project Health; Behavioral: Response and Attention Training

Male Group, Food Response Training

EXPERIMENTAL

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.

Behavioral: Project Health; Behavioral: Response and Attention Training

Educational Video control

ACTIVE COMPARATOR

Participants in this arm will be assigned to watch a four-part documentary "The Weight of the Nation" from their home.

Other: The Weight of the Nation

Interventions

Project Health BEHAVIORAL

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

Female Group, Food Response Training; Male Group, Food Response Training

Response and Attention Training BEHAVIORAL

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

Female Group, Food Response Training; Male Group, Food Response Training

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.

Educational Video control

Eligibility Criteria

• Age: 17 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Research Institute: lead
• Stanford University: collaborator
• Drexel University: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

Oregon Research Institute

Springfield, Oregon, 97477, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders

Study Officials

• Eric Stice, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be masked to participant condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 5, 2023
• Study Start: January 30, 2020
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After all follow-up assessments are completed and the main project papers are published, a dataset stripped of identifiers prior to release will be made available without cost to researchers and analysts.

Locations

US (2)