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Project Health: Enhancing Effectiveness of an Obesity Prevention Program

Oregon Research Institute logo

Oregon Research Institute

Status

Invitation-only

Conditions

Eating Disorders
Overweight and Obesity

Treatments

Behavioral: Project Health
Behavioral: Response and Attention Training
Other: The Weight of the Nation

Study type

Interventional

Funder types

Other

Identifiers

NCT06067763
HD093598

Details and patient eligibility

About

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.

Full 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).

Enrollment

238 estimated patients

Sex

All

Ages

17 to 20 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

238 participants in 3 patient groups

Female Group, Food Response Training
Experimental group
Description:
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.
Treatment:
Behavioral: Response and Attention Training
Behavioral: Project Health
Male Group, Food Response Training
Experimental group
Description:
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.
Treatment:
Behavioral: Response and Attention Training
Behavioral: Project Health
Educational Video control
Active Comparator group
Description:
Participants in this arm will be assigned to watch a four-part documentary "The Weight of the Nation" from their home.
Treatment:
Other: The Weight of the Nation

Trial contacts and locations

2

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Central trial contact

Paul Rohde, PhD; Kathryn Madden

Data sourced from clinicaltrials.gov

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