NCT01324661

Brief Summary

This study examines youth's motivation for food or social rewards after a brief episode of simulated ostracism. The investigators hypothesize that youth who think about a friend after being ostracized will mediate their decision to resort to food, which is typically evidenced in socially isolated overweight youth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
Last Updated

September 30, 2011

Status Verified

September 1, 2011

Enrollment Period

8 months

First QC Date

September 8, 2010

Last Update Submit

September 28, 2011

Conditions

Social ExclusionControl

Outcome Measures

Primary Outcomes (2)

  • Amount of food consumed after playing a computer game

    Participants' food consumption after playing a computer game is measured at the end of the study session

    Measured once during this 3-6 month study

  • The number of points earned for a snack food or social interaction.

    Participants' motivation to earn a reward is measured by the number of mouse clicks participants completed to obtain the reward.

    Measured once during this 3-6 month study

Study Arms (2)

Control

NO INTERVENTION

Individuals who receive the ball during a computerized ball tossing game about the same number of times as the other players in the game.

Ostracism

OTHER

Participant would receive the ball of a ball-tossing game once or twice in the beginning and then never again for the duration of the game.

Behavioral: Ostracism

Interventions

OstracismBEHAVIORAL

Participants would received the ball of a computerized ball-tossing game once or twice in the beginning and then never again for the duration of the game.

Ostracism

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • General liking for all study foods

You may not qualify if:

  • Food allergies
  • Medical or Psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo Division of Behavioral Medicine

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 8, 2010

First Posted

March 29, 2011

Study Start

December 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 30, 2011

Record last verified: 2011-09

Locations

US(1)