Social ExclusionNCT01324661
The Protective Effect of Friendship on Peer Rejection in Overweight and Normal Weight Youth
A study testing Ostracism in people with Social Exclusion and Control, run by University at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Exclusion, Control
- What is being tested?
- Ostracism
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Aug 2010
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- General liking for all study foods
Who cannot join
- Food allergies
- Medical or Psychological disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
University at Buffalo Division of Behavioral Medicine
Buffalo, New York, 14214
About this study
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.
- Conditions
- Social Exclusion, Control
- Being tested
- Ostracism
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OstracismBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Ostracism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured once during this 3-6 month study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startDec 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social ExclusionStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah-Jeanne Salvy, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324661
- Sponsor's protocol ID
- 3857
- Status last verified
- Sep 2011
- First submitted
- 8 Sep 2010
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Effect of Friendship on Peer Rejection in Overweight and Normal Weight Youth
- ClinicalTrials.gov ID
- NCT01324661
- Acronym / sponsor ID
- 3857
- Conditions
- Social Exclusion, Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 29 Mar 2011 (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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: OstracismParticipant 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. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- General liking for all study foods
Key exclusion criteria (2 listed)
- Food allergies
- Medical or Psychological disorders
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 |
|---|---|---|
| OstracismParticipants 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. | Behavioural | Ostracism |
Primary outcome
Amount of food consumed after playing a computer game
Time frame: Measured once during this 3-6 month study
Participants' food consumption after playing a computer game is measured at the end of the study session
The number of points earned for a snack food or social interaction.
Time frame: Measured once during this 3-6 month study
Participants' motivation to earn a reward is measured by the number of mouse clicks participants completed to obtain the reward.
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 30 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ostracism in people with Social Exclusion and Control, run by University at Buffalo 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 1 inclusion and 2 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 30 Sep 2011. 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?
Amount of food consumed after playing a computer game (time frame: Measured once during this 3-6 month study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2011.