Obesity Clinical Trial
Official title:
Influence of a Monopoly Game on Subtle Behaviors
This project will investigate the influence of experimentally manipulated perceived social standing on eating behavior and obesity risk.
Status | Completed |
Enrollment | 9 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 25 Years |
Eligibility |
Inclusion Criteria: - Ages 19-25 - Self-identified Hispanic ethnicity - Born in the United States - Body Mass Index (BMI) =18.5 and =30 kg/m2 - A score on the MacArthur scale of subjective social status =3 and =8 - No self-report of acute or chronic disease (heart disease, diabetes, gastrointestinal disorders in particular) - No plans for extended travel (>1 week) within the next 2 months - No current tobacco use - Capable and willing to give informed consent, understand inclusion criteria, and accept the randomized assignment Exclusion Criteria: - Never played monopoly before - Not born in the United States - Strict dietary restrictions (vegan, vegetarian, gluten-free, dairy-free/lactose intolerant, nut-allergies) - Participation in any weight reduction program, weight-loss diet, or other special diet within the previous 3 months - Weight loss or gain of =10 pounds in the past 6 months for any reason except post-partum weight loss - Currently taking medication that suppresses or stimulates appetite - Current smoker or quit smoking less than 6 months prior - Any major disease, including: - Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer). - Active or chronic infections, including self-reported HIV positivity and active tuberculosis. - Diagnosis of cardiovascular disease - Gastrointestinal disease, including inflammatory bowel disease that has required treatment in the past year, celiac disease, recent of significant abdominal surgery - Active renal disease - Lung disease such as chronic obstructive airway disease requiring use of oxygen - Diagnosis of diabetes (type 1 or type 2) - Uncontrolled psychiatric disease (such as schizophrenia and bipolar disorder) that, in the opinion of the investigators, would impede conduct of the trial or completion of procedures - A score on the Brief Symptom Inventory (BSI) (Derogatis & Melisaratos, 1983) that exceeds the 90th percentile - History of or current eating disorders, or an Eating Attitudes Test (EAT-26) score >20. - Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; another household member is a participant or staff member in the trial; unwilling to accept social status assignment by randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating university before visits are completed; unable to walk 0.25 mile in 10 minutes. - Currently taking antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months. - A recent or ongoing problem with drug abuse or addiction. - Excessive alcohol intake, either acute or chronic, defined as any one of the following: 1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24-hr period in the past 12 months; or 3) other evidence available to clinic staff. - Not willing to be randomized to any of the two experimental conditions. - Pregnancy and childbearing: currently pregnant or less than 3 months post-partum; currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated during study; unwilling to report possible or confirmed pregnancies promptly during the course of the trial; unwilling to take adequate contraceptive measures if potentially fertile. - Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Denver-Anschutz Medical Campus | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Brown University, University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Calories Selected and Consumed following the experimental manipulation | The participants will be provided with an ad libitum lunch for 30 minutes following the completion of their manipulated social status condition. | Administered 30 days apart | No |
Primary | The Macronutrient Composition of Foods Consumed | The participants will be provided with an ad libitum lunch for 30 minutes following the completion of their manipulated social status condition. | Administered 30 days apart | No |
Secondary | Body Mass Index | Height and Weight will be measured | Measured 30 days apart | No |
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