SmokingTEACHNCT02912000
TEACH: Technology Evaluation to Address Child Health
A study testing TEACH intervention in people with Smoking and Obesity, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The proposed study is a pre- /post-implementation study in a pediatric practice with a control practice designed to test the feasibility and effectiveness of an electronic screening and service delivery tool for three modifiable health risk factors in pediatrics: parental tobacco use, sugar-sweetened beverages… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Obesity, Dental Caries
- What is being tested?
- TEACH intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Mar 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent of a child aged 0-18 years
Who cannot join
- Parents under age 18
- Parents who have a child with a medical emergency (any condition requiring transfer for immediate medical intervention)
- Non-consenting individuals
- Non-English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The proposed study is a pre- /post-implementation study in a pediatric practice with a control practice designed to test the feasibility and effectiveness of an electronic screening and service delivery tool for three modifiable health risk factors in pediatrics: parental tobacco use, sugar-sweetened beverages consumption, and poor dental care
Read the detailed description
Key procedures of the study include:
- Practices will be contacted via letters, emails and in-person discussion with practice leaders.
- Among practices that say yes to recruitment, a total of 2 practices will be randomly assigned to one of two groups: 1) Implementation of the electronic screening tool 2) care as usual
- Control and intervention practices will be trained in integrating a Research Assistant (RA) who will be hired, trained, and paid by the research study. RAs will be through networking, temporary officeservice contractors, and other local resources.
- A notice to parents and teenagers will be posted where all can see it when registering for their pediatric visit. The notice will announce that the practice is participating in a research study and that parents/guardians and teenagers may be approached by a study RA. Practice staff will refer parents to the RA for the Eligibility Screener.
- In the control practice and in the pre-implementation phase of the intervention practice, after being seen by the pediatric clinician, the parent will be approached by the RA stationed near the exit of the clinic for an exit interview consisting of the Exit Survey. Alternatively, it the practice prefers to not have RAs directly approaching patients, practice staff will refer the potential participants to the RA after checkout. Parents who agree to study participation will learn about the study, sign the consent, and complete the Exit Survey for enrolled parents/guardians. Teenagers will not be invited or involved in this part of the study.
- In the post-implementation phase of the intervention practice, practice staff will follow a script at the check-in desk to refer parents to the RA. Parents will be approached by the RA after checking in for their appointment. Parents who agree to study participation will complete the Intake Survey. If they are accompanied by a teenager (aged 13-18 years old, the teenager will also be presented the study. Parents will be invited to consent to their child participate in the study. If the child is 13 years old, we will seek assent from the child to answer a portion of the intake survey. If he/she is 14 years or older, consent will be sought, and if obtained, the teenager will be asked to complete a section of the survey, on the same risk factors. We are asking that written documentation of these being waived and that consent/assent be inferred from survey participation, which will be documented in the research record. Teenagers will not be compensated for this section of the study that should take less than 5 minutes to complete. After completion of the survey, the adult participants will receive, if they desire, an information sheet on the risk factors identified, as well as a summary of the screening questionnaire, to be handed to the clinician they are coming to see that day. If no risk factor is identified, no clinician handout will be given. Teenagers' response to the survey will not be shared with parents and will only be available to the principal investigator and co-investigator. Adult participants will also be asked to reach out to the RA after their appointment to complete the Exit Survey, following the procedure mentioned above.
- One month after the recruitment and completion of the Exit Survey, adult participants will be contacted by phone by the RA or the Principal Investigator (PI) to complete the Follow-up survey. Consent for this survey will be obtain as part of the study initial consent and preferred phone numbers will be obtained directly from the participants. After completion of the Follow-up Survey, participation in the survey will be complete.
- Conditions
- Smoking, Obesity, Dental Caries
- Being tested
- TEACH intervention
- Keywords
- Dental Health Services, Sugar-Sweetened Beverages, Tobacco control, Pediatrics, Parents
- Medical subject headings
- Smoking, Obesity, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEACH interventionBehavioural
The TEACH intervention screens family for three modifiable behaviors ahead of the clinical encounter: parental tobacco use, children consumption of sugar-sweetened beverages and child dental health. The information from the screening is then shared with clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will receive the TEACH intervention - an electronic tablet screening in waiting room for the modifiable risk factors Receives: Behavioral: TEACH intervention |
| Control | No intervention | Care as usual: No electronic tablet in waiting room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported screening and counseling by physicians about parental smoking, child dentist appointment, and sugar-sweetened beverages
Higher rates of screening, counseling, and service delivery by clinicians in the period after implementation than at baseline (pre-implementation).
Measured: Pre-implementation (baseline) and Post-implementation
Secondary outcomes (2)
Parent report of behavior change intention related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment
Compared to the pre-implementation period, parents in the post-implementation period will have greater behavior change intention for each modifiable risk factor. This difference will be greater in the intervention practice than in the control practice.
Measured: At baseline and one month follow-up
Reported behavior change related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment
At one month follow-up, the intervention group will have a greater increase in reported healthy behavior than the control group.
Measured: one month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Pediatric Association, Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Jonathan P. Winickoff, MD, MPH, Massachusetts General Hospital
- Investigators
- Jonathan P Winickoff, MD MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912000
- Sponsor's protocol ID
- 2016P000711/MGH
- Acronym
- TEACH
- Status last verified
- Mar 2018
- First submitted
- 21 Sep 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEACH: Technology Evaluation to Address Child Health
- ClinicalTrials.gov ID
- NCT02912000
- Acronym / sponsor ID
- TEACH / 2016P000711/MGH
- Conditions
- Smoking, Obesity, Dental Caries
- Keywords
- Dental Health Services, Sugar-Sweetened Beverages, Tobacco control, Pediatrics, Parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Academic Pediatric Association, Fonds de la Recherche en Santé du Québec
- Study start
- Sep 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 23 Sep 2016 (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.
The proposed study is a pre- /post-implementation study in a pediatric practice with a control practice designed to test the feasibility and effectiveness of an electronic screening and service delivery tool for three modifiable health risk factors in pediatrics: parental tobacco use, sugar-sweetened beverages consumption, and poor dental care
Detailed description
Key procedures of the study include:
- Practices will be contacted via letters, emails and in-person discussion with practice leaders.
- Among practices that say yes to recruitment, a total of 2 practices will be randomly assigned to one of two groups: 1) Implementation of the electronic screening tool 2) care as usual
- Control and intervention practices will be trained in integrating a Research Assistant (RA) who will be hired, trained, and paid by the research study. RAs will be through networking, temporary officeservice contractors, and other local resources.
- A notice to parents and teenagers will be posted where all can see it when registering for their pediatric visit. The notice will announce that the practice is participating in a research study and that parents/guardians and teenagers may be approached by a study RA. Practice staff will refer parents to the RA for the Eligibility Screener.
- In the control practice and in the pre-implementation phase of the intervention practice, after being seen by the pediatric clinician, the parent will be approached by the RA stationed near the exit of the clinic for an exit interview consisting of the Exit Survey. Alternatively, it the practice prefers to not have RAs directly approaching patients, practice staff will refer the potential participants to the RA after checkout. Parents who agree to study participation will learn about the study, sign the consent, and complete the Exit Survey for enrolled parents/guardians. Teenagers will not be invited or involved in this part of the study.
- In the post-implementation phase of the intervention practice, practice staff will follow a script at the check-in desk to refer parents to the RA. Parents will be approached by the RA after checking in for their appointment. Parents who agree to study participation will complete the Intake Survey. If they are accompanied by a teenager (aged 13-18 years old, the teenager will also be presented the study. Parents will be invited to consent to their child participate in the study. If the child is 13 years old, we will seek assent from the child to answer a portion of the intake survey. If he/she is 14 years or older, consent will be sought, and if obtained, the teenager will be asked to complete a section of the survey, on the same risk factors. We are asking that written documentation of these being waived and that consent/assent be inferred from survey participation, which will be documented in the research record. Teenagers will not be compensated for this section of the study that should take less than 5 minutes to complete. After completion of the survey, the adult participants will receive, if they desire, an information sheet on the risk factors identified, as well as a summary of the screening questionnaire, to be handed to the clinician they are coming to see that day. If no risk factor is identified, no clinician handout will be given. Teenagers' response to the survey will not be shared with parents and will only be available to the principal investigator and co-investigator. Adult participants will also be asked to reach out to the RA after their appointment to complete the Exit Survey, following the procedure mentioned above.
- One month after the recruitment and completion of the Exit Survey, adult participants will be contacted by phone by the RA or the Principal Investigator (PI) to complete the Follow-up survey. Consent for this survey will be obtain as part of the study initial consent and preferred phone numbers will be obtained directly from the participants. After completion of the Follow-up Survey, participation in the survey will be complete.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: TEACH interventionThe intervention group will receive the TEACH intervention - an electronic tablet screening in waiting room for the modifiable risk factors |
| Control | No intervention | –Care as usual: No electronic tablet in waiting room |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parent of a child aged 0-18 years
Key exclusion criteria (4 listed)
- Parents under age 18
- Parents who have a child with a medical emergency (any condition requiring transfer for immediate medical intervention)
- Non-consenting individuals
- Non-English speakers
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 |
|---|---|---|
| TEACH interventionThe TEACH intervention screens family for three modifiable behaviors ahead of the clinical encounter: parental tobacco use, children consumption of sugar-sweetened beverages and child dental health. The information from the screening is then shared with clinicians. | Behavioural | Intervention |
Primary outcome
Reported screening and counseling by physicians about parental smoking, child dentist appointment, and sugar-sweetened beverages
Time frame: Pre-implementation (baseline) and Post-implementation
Higher rates of screening, counseling, and service delivery by clinicians in the period after implementation than at baseline (pre-implementation).
2 secondary outcomes
Parent report of behavior change intention related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment
Time frame: At baseline and one month follow-up
Reported behavior change related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment
Time frame: one month follow-up
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 22 Mar 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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.
Jonathan P Winickoff, MD MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEACH intervention in people with Smoking and Obesity, run by Massachusetts General Hospital 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 4 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 22 Mar 2018. 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?
Reported screening and counseling by physicians about parental smoking, child dentist appointment, and sugar-sweetened beverages (time frame: Pre-implementation (baseline) and Post-implementation). 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 22 Mar 2018.