- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02470949
Influence of a Monopoly Game on Subtle Behaviors
August 15, 2016 updated by: University of Colorado, Denver
This project will investigate the influence of experimentally manipulated perceived social standing on eating behavior and obesity risk.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The scope of work outlined in this proposal will investigate experimentally manipulated social status on acute eating behavior, energy intake, and risk for obesity.
This will be accomplished using a randomized, crossover design to place young adults in experimental high and low social status conditions.
At visit 1, participants will complete baseline measurements, and then consume a standardized breakfast.
In order to control for the influence of stress on eating behavior in both conditions, the participants will participate in the Stroop Test, a test known to induce stress in individuals, following breakfast.
Using a computerized randomization scheme, each participant will be randomized to either the low or high social status condition (½ will receive high first; ½ will receive low first) and will receive the packet of rules and instructions for their respective condition.
The participants will play Monopoly for up to 2 hours with another player they have not previously met.
At the end of the game, the high social status player will be told that they won, and the low social status player will be told that they lost.
The participants will participate in the Stroop Test again.
Then the investigators will take the players into the Children's Eating Laboratory, where a buffet ad libitum lunch will be served in separate rooms.
The participants will have 30 minutes to consume their lunch and plate waste will be measured to assess each participant's dietary intake.
There will be a 4-week washout period and the second visit will be exactly like the first, except that they will participate in the alternate social status condition.
The investigators will evaluate whether there was within-subject variation in dietary intakes based upon which social status condition they were placed in.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Denver-Anschutz Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low Social Status
Low Social Status Condition in Monopoly Game.
|
The participants will be randomized to the Low Social Status Condition.
On their second visit, they will undergo the condition in which they were not randomized to on their first visit.
|
|
Experimental: High Social Status
High Social Status Condition in Monopoly Game
|
The participants will be randomized to the High Social Status Condition.
On their second visit, they will undergo the condition in which they were not randomized to on their first visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Calories Consumed Following the Experimental Manipulation
Time Frame: Administered 30 days apart
|
The participants will be provided with an ad libitum lunch for 20 minutes following the completion of their manipulated social status condition.
|
Administered 30 days apart
|
|
The Macronutrient Composition of Foods Consumed
Time Frame: Administered 30 days apart
|
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
|
|
Percent of Calories Consumed Following the Experimental Manipulation
Time Frame: Administered 30 days apart
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michelle Cardel, PhD, RD, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
October 28, 2014
First Submitted That Met QC Criteria
June 11, 2015
First Posted (Estimate)
June 12, 2015
Study Record Updates
Last Update Posted (Estimate)
September 22, 2016
Last Update Submitted That Met QC Criteria
August 15, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14-0719
Plan for Individual participant data (IPD)
Study Data/Documents
-
Published Manuscript
Information identifier: 27094920
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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