An interventional study of Project Health and Response and Attention Training in Overweight and Obesity and Eating Disorders, sponsored by Oregon Research Institute. Enrolling by invitation at 2 sites in United States. Open to participants aged 17 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Oregon Research Institute · Not applicable, Interventional, and Prevention
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.
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).
Exclusion Criteria:
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 · Behavioral: Response and Attention 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 · Behavioral: Response and Attention Training
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
A brief dissonance-based obesity prevention program delivered in six one-hour weekly sessions.
Individualized, computerized response and attention training consisting of five separate tasks designed to increase inhibitory control to reduce overeating.
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.
Body Fat
Change in percentage of body fat as measured by air displacement plethysmography (ADP) via the Bod Pod.
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)
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.
Time frame: baseline, posttest (approximately 8 weeks later), 6-month follow-up (approximately 34 weeks after baseline), 12-month follow-up (approximately 60 weeks after baseline)
Plan to share: Yes — The investigators will share all study data via the NICHD Data and Specimen Hub (DASH), which is the centralized resource for researchers to store and access data from NICHD-funded research studies to use for secondary research. All data, with the exception of video recordings of the participants in treatment (which cannot be effectively de-identified), will be provided.
Supporting information: Study protocol, Icf, Csr
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Oregon Research Institute