Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

406

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach

1 country

2 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.7 years study duration

First Submitted

Initial submission to the registry

October 8, 2018

Completed

Same day until next milestone

Study Start

First participant enrolled

October 8, 2018

Completed

10 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed

6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed

Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

6.5 years

First QC Date

October 8, 2018

Last Update Submit

August 7, 2024

Conditions

Overweight and Obesity

Keywords

obesityoverweightpreventionadolescencedissonance

Outcome Measures

Primary Outcomes (1)

Body Fat
Change in percentage of body fat (Not collected during COVID-19 shelter-at-home order)
Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months

Secondary Outcomes (3)

Weight Concerns Scale from the Eating Disorder Examination Questionnaire (EDE-Q)
Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Beck Depression Index (BDI)
Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
Eating Disorder Interview (EDDI)
Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months

Study Arms (6)

Mixed Group, Food Response Training

EXPERIMENTAL

Participants in this arm will be assigned to receive Project Health in mixed-sex groups and will complete the food-focused response and attention training intervention.