NCT03710746: PH

Project Health: Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program

Active, enrolled NA Last updated 9 August 2024

What this trial tests

NA trial testing Project Health in Overweight and Obesity in 406 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 October 2018

Primary endpoint
31 March 2025

30 June 2025

Quick facts

Lead sponsor	Oregon Research Institute
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	prevention
Enrollment	406
Start date	8 October 2018
Primary completion	31 March 2025
Estimated completion	30 June 2025
Sites	2 locations across United States

Drugs / interventions tested

• Project Health
• Response and Attention Training

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

Oregon Research Institute

Who can join

Adults 17 to 20, any sex, with Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This project seeks to improve the effectiveness of a novel dissonance-based obesity prevention program that has reduced future BMI gain and overweight/obesity onset by (a) experimentally testing whether implementing it in single- versus mixed-sex groups, which should increase dissonance-induction that contributes to weight gain prevention effects, and (b) experimentally testing whether adding food response and attention training, which theoretically reduces valuation of and attention for high-calorie foods, increases weight gain prevention effects. This randomized trial would be the first to experimentally manipulate these two factors in an effort to produce superior weight gain prevention effects. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions to prevent obesity in children aged 12 to 18 years old.
   Spiga F, Tomlinson E, Davies AL, Moore TH, et al · · 2024 · cited 30× · PMID 38763518 · DOI 10.1002/14651858.cd015330.pub2