NCT02470949

Brief Summary

This project will investigate the influence of experimentally manipulated perceived social standing on eating behavior and obesity risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2014

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

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 16, 2016

Completed
Last Updated

September 22, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

October 28, 2014

Results QC Date

May 17, 2016

Last Update Submit

August 15, 2016

Conditions

ObesityEating Behavior

Keywords

body weightHispanicsEnergy IntakeSocial Status

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Administered 30 days apart

Study Arms (2)

Low Social Status

EXPERIMENTAL

Low Social Status Condition in Monopoly Game.

Behavioral: Low Social Status

High Social Status

EXPERIMENTAL

High Social Status Condition in Monopoly Game

Behavioral: High Social Status

Interventions

Low Social StatusBEHAVIORAL

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.

Low Social Status
High Social StatusBEHAVIORAL

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.

High Social Status

Eligibility Criteria

Age19 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver-Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

ObesityFeeding BehaviorBody Weight

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Results Point of Contact

Title
Michelle Cardel, PhD, RD
Organization
University of Florida
mcardel@ufl.edu
(352) 273-9703

Study Officials

  • Michelle Cardel, PhD, RD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2014

First Posted

June 12, 2015

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 22, 2016

Results First Posted

August 16, 2016

Record last verified: 2016-08

Locations

US(1)