ObesityNCT02470949
Influence of a Monopoly Game on Subtle Behaviors
A study testing Low Social Status and High Social Status in people with Obesity and Eating Behavior, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This project will investigate the influence of experimentally manipulated perceived social standing on eating behavior and obesity risk. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Eating Behavior
- What is being tested?
- Low Social Status and High Social Status
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver-Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
This project will investigate the influence of experimentally manipulated perceived social standing on eating behavior and obesity risk.
Read the 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.
- Conditions
- Obesity, Eating Behavior
- Being tested
- Low Social Status, High Social Status
- Keywords
- body weight, Hispanics, Energy Intake, Social Status
- Medical subject headings
- Obesity, Feeding Behavior, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Social StatusBehavioural
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.
High Social StatusBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Social Status | Experimental | Low Social Status Condition in Monopoly Game. Receives: Behavioral: Low Social Status |
| High Social Status | Experimental | High Social Status Condition in Monopoly Game Receives: Behavioral: High Social Status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calories Consumed Following the Experimental Manipulation
The participants will be provided with an ad libitum lunch for 20 minutes following the completion of their manipulated social status condition.
Measured: Administered 30 days apart
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.
Measured: Administered 30 days apart
Percent of Calories 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.
Measured: Administered 30 days apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Brown University
- Responsible party
- Sponsor
- Investigators
- Michelle Cardel, PhD, RD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470949
- Sponsor's protocol ID
- 14-0719
- Status last verified
- Aug 2016
- First submitted
- 28 Oct 2014
- Last updated
- 22 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Monopoly Game on Subtle Behaviors
- ClinicalTrials.gov ID
- NCT02470949
- Acronym / sponsor ID
- 14-0719
- Conditions
- Obesity, Eating Behavior
- Keywords
- body weight, Hispanics, Energy Intake, Social Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Brown University
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Posted 16 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will investigate the influence of experimentally manipulated perceived social standing on eating behavior and obesity risk.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Social Status | Experimental | Behavioral: Low Social StatusLow Social Status Condition in Monopoly Game. |
| High Social Status | Experimental | Behavioral: High Social StatusHigh Social Status Condition in Monopoly Game |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Social StatusThe 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. | Behavioural | Low Social Status |
| High Social StatusThe 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. | Behavioural | High Social Status |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Cardel, PhD, RD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Social Status and High Social Status in people with Obesity and Eating Behavior, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calories Consumed Following the Experimental Manipulation (time frame: Administered 30 days apart). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.