Psychosocial Influence on Cardiovascular DiseaseNCT02729389
Influence of Monopoly Game on Subtle Behaviors
A study testing High Social Status Condition and Low Social Status Condition in people with Psychosocial Influence on Cardiovascular Disease and Cardiovascular Disease, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to investigate how social standing in a game of Monopoly may influence behavior. Read more about this study
- Who is it for?
- Ages 15 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Influence on Cardiovascular Disease, Cardiovascular Disease
- What is being tested?
- High Social Status Condition and Low Social Status Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 7 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Hispanic American adolescents born in the United States
- Have played Monopoly before
Who cannot join
- Clinical depression
- A diagnosis of cardiovascular disease (active or within the past 6 months), cancer (active or within the past 2 years, except non-melanoma skin cancer), diabetes (type 1 or 2), active or chronic infections, gastrointestinal disease, active kidney disease, lung disease, uncontrolled psychiatric disease
- An eating disorder or severely restricted diet
- Use of tobacco products
- Substance abuse disorder
- Take any medications known to affect appetite or body composition
Show all 10Show fewer
- Participation in any weight-reduction programs, weight-loss diets, or other special diets within the previous 3 months
- Experience of weight loss or gain of 10 pounds or more of body weight in the past 6 months for any reason except post-partum weight loss
- Current/Anticipation of pregnancy during study
- Currently nursing or within 6 weeks of having completed nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Clinical Translational Science Institute
Gainesville, Florida, 32610
About this study
Official title: The Effects of Experimentally Manipulated Social Status on Energy Balance in Youth: A Randomized Controlled Trial
The purpose of this research study is to investigate how social standing in a game of Monopoly may influence behavior.
Read the detailed description
Participants will be asked to fill out questionnaires/surveys and health measures will be collected throughout the study visit. These health measures will include: blood pressure, heart rate, height/weight, waist circumference, percent body fat, resting metabolic rate, and salivary cortisol. Breakfast will be provided and then a 40-minute game of Monopoly™ will be played, and lunch will be provided after the game. Participants will be given an accelerometer to measure movements, and a food diary to be used for a 24-hour period. Once the 24-hour monitoring period has been completed, the participants will be finished with the study activities. The accelerometer and food diary will be returned by either bringing them to the investigators or mailing the items back to the investigators.
- Being tested
- High Social Status Condition, Low Social Status Condition
- Keywords
- Social Status, Hispanics, Energy Balance, Stress
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Social Status ConditionBehavioural
Participants will be provided with a high degree of privilege in a game of Monopoly.
Low Social Status ConditionBehavioural
Participants will be provided with a low degree of privilege in a game of Monopoly.
| Study group | Role | What they receive |
|---|---|---|
| High Social Status Condition | Experimental | Participants will be provided with a high degree of privilege in a game of Monopoly. Receives: Behavioral: High Social Status Condition |
| Low Social Status Condition | Experimental | Participants will be provided with a low degree of privilege in a game of Monopoly. Receives: Behavioral: Low Social Status Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy balance between the groups at hour 4 and over 24 hours
The investigators will assess energy balance using accelerometry, consumption data and resting metabolic rate.
Measured: Hour 4, After 24 Hours
Secondary outcomes (4)
Change in blood pressure between the groups at hours 0, 1, 3, 4
Systolic and diastolic blood pressure will be assessed.
Measured: Hours 0, 1, 3, 4
Change in heart rate between the groups at hours 0, 1, 3, 4
Heart rate will be captured using a heart rate monitor.
Measured: Hours 0, 1, 3, 4
Change in salivary cortisol between the groups at hours 1, 3
Salivary cortisol will be collected and tested to determine objective stress levels.
Measured: Hours 1, 3
Change in Visual Analog Scales (VAS) between the groups at hours 0, 1, 3, 4
Scores are from 0 - 100, 0 generally meaning least and 100 generally meaning most.
Measured: Hours 0, 1, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJun 2016
- Primary completion7 Jul 2018
- Study completion7 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychosocial Influence on Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Brown University
- Responsible party
- Sponsor
- Investigators
- Michelle I Cardel, PhD, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729389
- Sponsor's protocol ID
- IRB201600361
- Status last verified
- Sep 2019
- First submitted
- 31 Mar 2016
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee AM, Huo T, Miller D, Gurka MJ, Thompson LA, Modave FP, Hong YR, Pavela G, Cardel MI. The effects of experimentally manipulated social status and subjective social status on physical activity among Hispanic adolescents: An RCT. Pediatr Obes. 2022 May;17(5):e12877. doi: 10.1111/ijpo.12877. Epub 2021 Dec 3.
PubMed 34859604Cardel MI, Pavela G, Janicke D, Huo T, Miller D, Lee AM, Gurka MJ, Dhurandhar E, Peters JC, Caldwell AE, Krause E, Fernandez A, Allison DB. Experimentally Manipulated Low Social Status and Food Insecurity Alter Eating Behavior Among Adolescents: A Randomized Controlled Trial. Obesity (Silver Spring). 2020 Nov;28(11):2010-2019. doi: 10.1002/oby.23002.
PubMed 33150744
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Experimentally Manipulated Social Status on Energy Balance in Youth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02729389
- Acronym / sponsor ID
- IRB201600361
- Keywords
- Social Status, Hispanics, Energy Balance, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Brown University
- Study start
- Jun 2016 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 7 Jul 2018 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to investigate how social standing in a game of Monopoly may influence behavior.
Detailed description
Participants will be asked to fill out questionnaires/surveys and health measures will be collected throughout the study visit. These health measures will include: blood pressure, heart rate, height/weight, waist circumference, percent body fat, resting metabolic rate, and salivary cortisol. Breakfast will be provided and then a 40-minute game of Monopoly™ will be played, and lunch will be provided after the game. Participants will be given an accelerometer to measure movements, and a food diary to be used for a 24-hour period. Once the 24-hour monitoring period has been completed, the participants will be finished with the study activities. The accelerometer and food diary will be returned by either bringing them to the investigators or mailing the items back to the investigators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Social Status Condition | Experimental | Behavioral: High Social Status ConditionParticipants will be provided with a high degree of privilege in a game of Monopoly. |
| Low Social Status Condition | Experimental | Behavioral: Low Social Status ConditionParticipants will be provided with a low degree of privilege in a game of Monopoly. |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Hispanic American adolescents born in the United States
- Have played Monopoly before
Key exclusion criteria (10 listed)
- Clinical depression
- A diagnosis of cardiovascular disease (active or within the past 6 months), cancer (active or within the past 2 years, except non-melanoma skin cancer), diabetes (type 1 or 2), active or chronic infections, gastrointestinal disease, active kidney disease, lung disease, uncontrolled psychiatric disease
- An eating disorder or severely restricted diet
- Use of tobacco products
- Substance abuse disorder
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 |
|---|---|---|
| High Social Status ConditionParticipants will be provided with a high degree of privilege in a game of Monopoly. | Behavioural | High Social Status Condition |
| Low Social Status ConditionParticipants will be provided with a low degree of privilege in a game of Monopoly. | Behavioural | Low Social Status Condition |
Primary outcome
Energy balance between the groups at hour 4 and over 24 hours
Time frame: Hour 4, After 24 Hours
The investigators will assess energy balance using accelerometry, consumption data and resting metabolic rate.
4 secondary outcomes
Change in blood pressure between the groups at hours 0, 1, 3, 4
Time frame: Hours 0, 1, 3, 4
Change in heart rate between the groups at hours 0, 1, 3, 4
Time frame: Hours 0, 1, 3, 4
Change in salivary cortisol between the groups at hours 1, 3
Time frame: Hours 1, 3
Change in Visual Analog Scales (VAS) between the groups at hours 0, 1, 3, 4
Time frame: Hours 0, 1, 3, 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Derived from this study: PubMed 34859604Lee AM, Huo T, Miller D, Gurka MJ, Thompson LA, Modave FP, Hong YR, Pavela G, Cardel MI. The effects of experimentally manipulated social status and subjective social status on physical activity among Hispanic adolescents: An RCT. Pediatr Obes. 2022 May;17(5):e12877. doi: 10.1111/ijpo.12877. Epub 2021 Dec 3.
- Derived from this study: PubMed 33150744Cardel MI, Pavela G, Janicke D, Huo T, Miller D, Lee AM, Gurka MJ, Dhurandhar E, Peters JC, Caldwell AE, Krause E, Fernandez A, Allison DB. Experimentally Manipulated Low Social Status and Food Insecurity Alter Eating Behavior Among Adolescents: A Randomized Controlled Trial. Obesity (Silver Spring). 2020 Nov;28(11):2010-2019. doi: 10.1002/oby.23002.
- Individual participant dataSharing planned: No
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Recruiting
Probing the Role of Mitochondrial Oxidative Stress in Impaired Vascular Function Among Young Adults With Early Life Adversity
Adverse Childhood Experience, Endothelial Function (FMD)
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 I Cardel, PhD, RD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Social Status Condition and Low Social Status Condition in people with Psychosocial Influence on Cardiovascular Disease and Cardiovascular Disease, run by University of Florida 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 2 inclusion and 10 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 17 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Energy balance between the groups at hour 4 and over 24 hours (time frame: Hour 4, After 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02729389, which also lists 2 linked publications.
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 17 Sep 2019.