NCT02729389

Brief Summary

The purpose of this research study is to investigate how social standing in a game of Monopoly may influence behavior.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2018

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

March 31, 2016

Last Update Submit

September 13, 2019

Conditions

Psychosocial Influence on Cardiovascular DiseaseCardiovascular Disease

Keywords

Social StatusHispanicsEnergy BalanceStress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in blood pressure between the groups at hours 0, 1, 3, 4

    Hours 0, 1, 3, 4

  • Change in heart rate between the groups at hours 0, 1, 3, 4

    Hours 0, 1, 3, 4

  • Change in salivary cortisol between the groups at hours 1, 3

    Hours 1, 3

  • Change in Visual Analog Scales (VAS) between the groups at hours 0, 1, 3, 4

    Hours 0, 1, 3, 4

Study Arms (2)

High Social Status Condition

EXPERIMENTAL

Participants will be provided with a high degree of privilege in a game of Monopoly.

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.

Behavioral: Low Social Status Condition

Interventions

High Social Status ConditionBEHAVIORAL

Participants will be provided with a high degree of privilege in a game of Monopoly.

High Social Status Condition
Low Social Status ConditionBEHAVIORAL

Participants will be provided with a low degree of privilege in a game of Monopoly.

Low Social Status Condition

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Hispanic American adolescents born in the United States
  • Have played Monopoly before

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Clinical Translational Science Institute

Gainesville, Florida, 32610, United States

Location

Related Publications (2)

  • 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.

    PMID: 34859604DERIVED

  • Cardel 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.

    PMID: 33150744DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Michelle I Cardel, PhD, RD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 6, 2016

Study Start

June 1, 2016

Primary Completion

July 7, 2018

Study Completion

July 7, 2018

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)