ObesityPhase 4NCT00959309
Media Use in Preschooler Study (MUPS)
A Phase 4 study testing Strategies to decrease screen time in children and Non-Strategical Media Education in people with Obesity, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Childhood obesity is an epidemic and increasing. There are very few effective treatments for obesity in children. Recent studies have shown an association between obesity and sedentary behaviors such as television, video viewing and playing video games ('screen time') in preschool aged children. Read more about this study
- Who is it for?
- Ages 3 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Strategies to decrease screen time in children and Non-Strategical Media Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Dec 2009
- Phase
- Phase 4
- 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 3 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- registered to attend a 3 year old well child visit
Who cannot join
- children with limitations in ambulation or cognitive delay will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Media Use in Preschooler Study (MUPS) An Office Based Intervention to Improve Media Use in Preschool Children: a Randomized Controlled Trial
Childhood obesity is an epidemic and increasing. There are very few effective treatments for obesity in children. Recent studies have shown an association between obesity and sedentary behaviors such as television, video viewing and playing video games ('screen time') in preschool aged children. A school based intervention to reduce screen time in older children has been effective in preventing obesity.
The reduction of screen time may lead to the prevention of obesity and its complications in preschool children.
Read the detailed description
There have been no trials examining an intervention to decrease screen time in preschool children in the physician office setting. This setting is appealing for interventions directed to preschool children because of accessibility. In addition, other public health interventions implemented in a physician office setting, such as home safety advice, have been effective.
The proposed study design will be a randomized controlled trial. The intervention group will receive the study intervention, which is a 15 minute session about the health impact of screen time in children and strategies to decrease screen time.
The objective of this study is to determine if an office based intervention is effective in decreasing screen time (television, video viewing and playing video games) in preschool children.
- Conditions
- Obesity
- Being tested
- Strategies to decrease screen time in children, Non-Strategical Media Education
- Keywords
- pediatrics, media, MUPS
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategies to decrease screen time in childrenBehavioural
15 minute session about the health impact of screen time in children and strategies to decrease screen time (removing televisions from the child's bedroom, budgeting screen time, providing a contingency plan for time spent not watching TV, encouraging family meal time, and implementing a one week television turn off, where children are encouraged to spend one week without watching TV/videos). Activities for the child include reading a story about television viewing (The Berenstain Bears and Too Much TV), and creating a list of non TV related activities to replace TV time. The intervention group will receive a CPS handout titled 'Promoting Good Television Habits' and a calendar with stickers for the television turn off.
Educational session on good media use (information on television rating systems, internet safety, and limiting exposure to violent programming, and the CPS handout entitled 'Managing Media in the Home')
Non-Strategical Media EducationBehavioural
Educational session on good media use (information on television rating systems, internet safety, and limiting exposure to violent programming, and the CPS handout entitled 'Managing Media in the Home')
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Strategies to decrease screen time in children |
| Control | Active comparator | Not described Receives: Behavioral: Non-Strategical Media Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent reported number of hours screen time on the previous weekday and previous weekend day
Measured: 6 and 12 months
Secondary outcomes (3)
Number of meals in front of the TV
Measured: 6 and 12 months
Activity levels
Measured: 6 and 12 months
Anthropometric measures
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startOct 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Birken, The Hospital for Sick Children
- Investigators
- Catherine Birken, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959309
- Sponsor's protocol ID
- 1000009542
- Status last verified
- Nov 2017
- First submitted
- 12 Aug 2009
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Media Use in Preschooler Study (MUPS) An Office Based Intervention to Improve Media Use in Preschool Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00959309
- Acronym / sponsor ID
- 1000009542
- Conditions
- Obesity
- Keywords
- pediatrics, media, MUPS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Aug 2009 (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.
Childhood obesity is an epidemic and increasing. There are very few effective treatments for obesity in children. Recent studies have shown an association between obesity and sedentary behaviors such as television, video viewing and playing video games ('screen time') in preschool aged children. A school based intervention to reduce screen time in older children has been effective in preventing obesity.
The reduction of screen time may lead to the prevention of obesity and its complications in preschool children.
Detailed description
There have been no trials examining an intervention to decrease screen time in preschool children in the physician office setting. This setting is appealing for interventions directed to preschool children because of accessibility. In addition, other public health interventions implemented in a physician office setting, such as home safety advice, have been effective.
The proposed study design will be a randomized controlled trial. The intervention group will receive the study intervention, which is a 15 minute session about the health impact of screen time in children and strategies to decrease screen time.
The objective of this study is to determine if an office based intervention is effective in decreasing screen time (television, video viewing and playing video games) in preschool children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Strategies to decrease screen time in children |
| Control | Active comparator | Behavioral: Non-Strategical Media Education |
Who may qualify
- Ages
- 3 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- registered to attend a 3 year old well child visit
Key exclusion criteria (1 listed)
- children with limitations in ambulation or cognitive delay will be excluded from the study.
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 |
|---|---|---|
| Strategies to decrease screen time in children15 minute session about the health impact of screen time in children and strategies to decrease screen time (removing televisions from the child's bedroom, budgeting screen time, providing a contingency plan for time spent not watching TV, encouraging family meal time, and implementing a one week television turn off, where children are encouraged to spend one week without watching TV/videos). Activities for the child include reading a story about television viewing (The Berenstain Bears and Too Much TV), and creating a list of non TV related activities to replace TV time. The intervention group will receive a CPS handout titled 'Promoting Good Television Habits' and a calendar with stickers for the television turn off. Educational session on good media use (information on television rating systems, internet safety, and limiting exposure to violent programming, and the CPS handout entitled 'Managing Media in the Home') | Behavioural | Intervention |
| Non-Strategical Media EducationEducational session on good media use (information on television rating systems, internet safety, and limiting exposure to violent programming, and the CPS handout entitled 'Managing Media in the Home') | Behavioural | Control |
Primary outcome
Parent reported number of hours screen time on the previous weekday and previous weekend day
Time frame: 6 and 12 months
3 secondary outcomes
Number of meals in front of the TV
Time frame: 6 and 12 months
Activity levels
Time frame: 6 and 12 months
Anthropometric measures
Time frame: 12 months
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 13 Nov 2017.
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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.
Catherine Birken, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Strategies to decrease screen time in children and Non-Strategical Media Education in people with Obesity, run by The Hospital for Sick Children at 1 site in Canada.
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 1 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 13 Nov 2017. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Parent reported number of hours screen time on the previous weekday and previous weekend day (time frame: 6 and 12 months). 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 13 Nov 2017.