Project Health: Enhancing Effectiveness of an Obesity Prevention Program

Part of paid clinical trials in Stanford, California.

Sponsor
Oregon Research Institute
Study ID
NCT06067763
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
17 Years - 20 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 30, 2020
Status verified
Nov 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
238 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Body Fat [ Time Frame: 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) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-
Oregon Research InstituteSpringfieldOregon97477-

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