Cardiovascular Disease Clinical Trial
Official title:
The Effects of Experimentally Manipulated Social Status on Energy Balance in Youth: A Randomized Controlled Trial
NCT number | NCT02729389 |
Other study ID # | IRB201600361 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | July 7, 2018 |
Verified date | September 2019 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to investigate how social standing in a game of Monopoly may influence behavior.
Status | Completed |
Enrollment | 133 |
Est. completion date | July 7, 2018 |
Est. primary completion date | July 7, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 21 Years |
Eligibility |
Inclusion Criteria: - Hispanic American adolescents born in the United States - Have played Monopoly before Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida Clinical Translational Science Institute | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Brown University, University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Hour 4, After 24 Hours | |
Secondary | Change in blood pressure between the groups at hours 0, 1, 3, 4 | Systolic and diastolic blood pressure will be assessed. | Hours 0, 1, 3, 4 | |
Secondary | Change in heart rate between the groups at hours 0, 1, 3, 4 | Heart rate will be captured using a heart rate monitor. | Hours 0, 1, 3, 4 | |
Secondary | Change in salivary cortisol between the groups at hours 1, 3 | Salivary cortisol will be collected and tested to determine objective stress levels. | Hours 1, 3 | |
Secondary | 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. | Hours 0, 1, 3, 4 |
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