Project Health: Enhancing Effectiveness of an Obesity Prevention Program

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06067763
• Other study ID #: HD093598
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 30, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 238
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 20 Years

Eligibility

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

Exclusion Criteria:

• Current diagnosis of anorexia nervosa, bulimia nervosa or binge eating disorder

• Previous participation in a Project Health study

Related Conditions & MeSH terms

• Eating Disorders
• Feeding and Eating Disorders
• Obesity
• Overweight
• Overweight and Obesity

Intervention

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

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.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Springfield	Oregon
United States	Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Research Institute	Drexel University, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Eating Disorder Symptoms	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.	baseline, posttest (approximately 8 weeks later), 6-month follow-up (approximately 34 weeks after baseline), 12-month follow-up (approximately 60 weeks after baseline)