Tobacco UseNCT03322501
Pediatric Health Promotion Program
A study testing Provider Advice, Framed Messaging in people with Tobacco Use, run by Georgetown University at 1 site in United States.
Trial summary
The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Provider Advice, Framed Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2015to 1 Nov 2018
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Well-child visit
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients.
- Conditions
- Tobacco Use
- Being tested
- Provider Advice, Framed Messaging
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider Advice, Framed MessagingBehavioural
The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients. Receives: Behavioral: Provider Advice, Framed Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco Use
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start7 Aug 2015
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322501
- Sponsor's protocol ID
- 2015-0787
- Status last verified
- Jan 2019
- First submitted
- 24 Oct 2017
- Last updated
- 18 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Health Promotion Program
- ClinicalTrials.gov ID
- NCT03322501
- Acronym / sponsor ID
- 2015-0787
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 7 Aug 2015 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 26 Oct 2017 (actual)
- 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.
The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Provider Advice, Framed MessagingThe purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Well-child visit
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Provider Advice, Framed MessagingThe purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients. | Behavioural | Intervention |
Primary outcome
Tobacco Use
Time frame: 1 Month
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 18 Jan 2019.
- Individual participant dataSharing planned: No
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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 Provider Advice, Framed Messaging in people with Tobacco Use, run by Georgetown University 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 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 18 Jan 2019. 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?
Tobacco Use (time frame: 1 Month). 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 18 Jan 2019.