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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Social Status
Low Social Status Condition in Monopoly Game.
Behavioral: Low Social Status
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
Behavioral: High Social Status
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Alabama at Birmingham
Brown University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-0719

Plan for Individual participant data (IPD)

Study Data/Documents

  1. 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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