Project Health: Enhancing Effectiveness of an Obesity Prevention Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-30

Study Completion Date

2025-07-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Overweight and Obesity Eating Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors will be masked to participant condition.

Study Groups

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Female Group, Food Response 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.

Group Type EXPERIMENTAL

Project Health

Intervention Type BEHAVIORAL

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

Response and Attention Training

Intervention Type BEHAVIORAL

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

Male Group, Food Response 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.

Group Type EXPERIMENTAL

Project Health

Intervention Type BEHAVIORAL

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

Response and Attention Training

Intervention Type BEHAVIORAL

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

Educational Video control

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

Group Type ACTIVE_COMPARATOR

The Weight of the Nation

Intervention Type 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.

Interventions

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The Weight of the Nation

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.

Intervention Type OTHER

Project Health

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

Intervention Type BEHAVIORAL

Response and Attention Training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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