PH Phase 2: Project Health: Enhancing Effectiveness of a Dissonance-based Obesity Prevention Program (Phase 2)

Sponsor

Oregon Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT06067763

Collaborator

Stanford University (Other), Drexel University (Other)

238

Enrollment

Locations

Arms

Anticipated Duration (Months)

119

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity Eating Disorders	Behavioral: Project Health Behavioral: Response and Attention Training Other: The Weight of the Nation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

238 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcome assessors will be masked to participant condition.

Primary Purpose:

Prevention

Official Title:

Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program: Randomized Controlled Trial

Actual Study Start Date :

Jun 30, 2020

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Project Health A brief dissonance-based obesity prevention program delivered in six one-hour weekly sessions. Behavioral: Response and Attention Training Individualized, computerized response and attention training consisting of five separate tasks designed to increase inhibitory control to reduce overeating.
Experimental: 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.	Behavioral: Project Health A brief dissonance-based obesity prevention program delivered in six one-hour weekly sessions. Behavioral: Response and Attention Training Individualized, computerized response and attention training consisting of five separate tasks designed to increase inhibitory control to reduce overeating.
Active Comparator: Educational Video control 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 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Project Health

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

Behavioral: Response and Attention Training

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

Experimental: 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.

Behavioral: Project Health

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

Behavioral: Response and Attention Training

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

Active Comparator: Educational Video control

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

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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