Trial Outcomes & Findings for An Intervention to Reduce Second Hand Smoke Exposure Among Pediatric Emergency Patients (NCT NCT02531594)
NCT ID: NCT02531594
Last Updated: 2023-09-15
Results Overview
Primary outcomes are self-reported prolonged abstinence at 6-weeks post-enrollment, validated in all participants via salivary cotinine levels.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
770 participants
Primary outcome timeframe
6 weeks post enrollment
Results posted on
2023-09-15
Participant Flow
The numbers listed below represent a dyad (child participant/caregiver participant).
Participant milestones
| Measure |
SBIRT
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
|
Healthy Habits Control
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
|
|---|---|---|
|
Overall Study
STARTED
|
384
|
381
|
|
Overall Study
COMPLETED
|
377
|
373
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
SBIRT
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
|
Healthy Habits Control
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
Baseline Characteristics
Some participants' gender was not reported in baseline questionnaire.
Baseline characteristics by cohort
| Measure |
Healthy Habits Control
n=373 Participants
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
|
SBIRT
n=377 Participants
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
|
Total
n=750 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Child Participants · <=18 years
|
373 Participants
n=5 Participants
|
377 Participants
n=7 Participants
|
750 Participants
n=5 Participants
|
|
Age, Categorical
Child Participants · Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Child Participants · >=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Caregiver participants · <=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Caregiver participants · Between 18 and 65 years
|
373 Participants
n=5 Participants
|
377 Participants
n=7 Participants
|
750 Participants
n=5 Participants
|
|
Age, Categorical
Caregiver participants · >=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
Child Participants
|
4.73 years
STANDARD_DEVIATION 4.51 • n=5 Participants
|
5.12 years
STANDARD_DEVIATION 4.89 • n=7 Participants
|
4.92 years
STANDARD_DEVIATION 4.70 • n=5 Participants
|
|
Age, Continuous
Caregiver Participants
|
32.59 years
STANDARD_DEVIATION 7.06 • n=5 Participants
|
33.12 years
STANDARD_DEVIATION 8.20 • n=7 Participants
|
32.89 years
STANDARD_DEVIATION 7.67 • n=5 Participants
|
|
Sex: Female, Male
Child Participants · Female
|
177 Participants
n=5 Participants • Some participants' gender was not reported in baseline questionnaire.
|
185 Participants
n=7 Participants • Some participants' gender was not reported in baseline questionnaire.
|
362 Participants
n=5 Participants • Some participants' gender was not reported in baseline questionnaire.
|
|
Sex: Female, Male
Child Participants · Male
|
196 Participants
n=5 Participants • Some participants' gender was not reported in baseline questionnaire.
|
192 Participants
n=7 Participants • Some participants' gender was not reported in baseline questionnaire.
|
388 Participants
n=5 Participants • Some participants' gender was not reported in baseline questionnaire.
|
|
Sex: Female, Male
Caregiver Participants · Female
|
321 Participants
n=5 Participants • Some participants' gender was not reported in baseline questionnaire.
|
330 Participants
n=7 Participants • Some participants' gender was not reported in baseline questionnaire.
|
651 Participants
n=5 Participants • Some participants' gender was not reported in baseline questionnaire.
|
|
Sex: Female, Male
Caregiver Participants · Male
|
52 Participants
n=5 Participants • Some participants' gender was not reported in baseline questionnaire.
|
47 Participants
n=7 Participants • Some participants' gender was not reported in baseline questionnaire.
|
99 Participants
n=5 Participants • Some participants' gender was not reported in baseline questionnaire.
|
|
Ethnicity (NIH/OMB)
Child Participants · Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Child Participants · Not Hispanic or Latino
|
369 Participants
n=5 Participants
|
368 Participants
n=7 Participants
|
737 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Child Participants · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Caregiver Participants · Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Caregiver Participants · Not Hispanic or Latino
|
363 Participants
n=5 Participants
|
368 Participants
n=7 Participants
|
731 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Caregiver Participants · Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child Participants · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child Participants · Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child Participants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child Participants · Black or African American
|
215 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
430 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child Participants · White
|
142 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child Participants · More than one race
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child Participants · Unknown or Not Reported
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Caregiver Participants · American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Caregiver Participants · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Caregiver Participants · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Caregiver Participants · Black or African American
|
200 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
400 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Caregiver Participants · White
|
150 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Caregiver Participants · More than one race
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Caregiver Participants · Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
373 participants
n=5 Participants
|
377 participants
n=7 Participants
|
750 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post enrollmentPrimary outcomes are self-reported prolonged abstinence at 6-weeks post-enrollment, validated in all participants via salivary cotinine levels.
Outcome measures
| Measure |
SBIRT
n=377 Participants
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
|
Healthy Habits Control
n=373 Participants
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
|
|---|---|---|
|
Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks
|
4.2 percentage of participants
|
4.2 percentage of participants
|
PRIMARY outcome
Timeframe: 6months post enrollmentPrimary outcomes are self-reported prolonged abstinence at 6 months post-enrollment, validated in all participants via salivary cotinine levels.
Outcome measures
| Measure |
SBIRT
n=377 Participants
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
|
Healthy Habits Control
n=373 Participants
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
|
|---|---|---|
|
Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months
|
12.9 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: baseline and 6 weeks post enrollmentSecondary outcomes include number of cigarettes smoked at 6 weeks post enrollment. This number is reporting a change in the number of cigarettes smoked between baseline and six weeks.
Outcome measures
| Measure |
SBIRT
n=377 Participants
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
|
Healthy Habits Control
n=373 Participants
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
|
|---|---|---|
|
Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Weeks
|
-2 cigarettes per week
Interval -5.0 to 0.0
|
0 cigarettes per week
Interval -4.0 to 0.0
|
SECONDARY outcome
Timeframe: baseline and 6 months post enrollmentSecondary outcomes include number of cigarettes smoked at 6 months post enrollment as compared with baseline.
Outcome measures
| Measure |
SBIRT
n=377 Participants
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
|
Healthy Habits Control
n=373 Participants
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
|
|---|---|---|
|
Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months
|
-4 cigarettes per week
Interval -9.0 to -1.0
|
-2 cigarettes per week
Interval -5.0 to 0.0
|
SECONDARY outcome
Timeframe: 6 weeks post enrollmentSecondary outcomes include number of quit attempts at 6 weeks post enrollment.
Outcome measures
| Measure |
SBIRT
n=377 Participants
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
|
Healthy Habits Control
n=373 Participants
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
|
|---|---|---|
|
Number of Quit Attempts at 6 Weeks
|
2.69 quit attempts
Standard Deviation 5.0
|
2.22 quit attempts
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 6 months post enrollmentSecondary outcomes include number of quit attempts at 6 months post enrollment.
Outcome measures
| Measure |
SBIRT
n=377 Participants
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
|
Healthy Habits Control
n=373 Participants
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
|
|---|---|---|
|
Number of Quit Attempts at 6 Months
|
3.82 quit attempts
Standard Deviation 6.4
|
2.3 quit attempts
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 6 weeks post enrollmentSecondary outcomes include readiness to quit at 6 weeks post enrollment as measured by a readiness to quit scale. Scale name: The Contemplation Ladder Reference: Biener L., Abrams D.B. The Contemplation Ladder: Validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10:360-365. doi: 10.1037/0278-6133.10.5.360. What scale measures: the smoker's motivation to quit smoking. The Contemplation Ladder is a validated score that correlates with the likelihood of making a quit attempt and participation in activities associated with quit attempts. The Contemplation Ladder is a 1-item, 11-point scale of motivation to quit. The question asks: "Mark the number that shows how you feel about quitting. Minimum score: 0 = no thought of quitting Maximum score: 10= taking action to quit Lower scores indicate worse outcomes. Higher scores indicate better outcomes. There are no subscales and one score is chosen by the smoker.
Outcome measures
| Measure |
SBIRT
n=377 Participants
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
|
Healthy Habits Control
n=373 Participants
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
|
|---|---|---|
|
Readiness to Quit at 6 Weeks
|
6.98 units on a scale
Standard Deviation 2.5
|
6.46 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 6 months post enrollmentSecondary outcomes include readiness to quit at 6 months post enrollment as measured by a readiness to quit scale. Scale name: The Contemplation Ladder Reference: Biener L., Abrams D.B. The Contemplation Ladder: Validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10:360-365. doi: 10.1037/0278-6133.10.5.360. What scale measures: the smoker's motivation to quit smoking. The Contemplation Ladder is a validated score that correlates with the likelihood of making a quit attempt and participation in activities associated with quit attempts. The Contemplation Ladder is a 1-item, 11-point scale of motivation to quit. The question asks: "Mark the number that shows how you feel about quitting. Minimum score: 0 = no thought of quitting Maximum score: 10= taking action to quit Lower scores indicate worse outcomes. Higher scores indicate better outcomes. There are no subscales and one score is chosen by the smoker.
Outcome measures
| Measure |
SBIRT
n=377 Participants
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
|
Healthy Habits Control
n=373 Participants
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
|
|---|---|---|
|
Readiness to Quit at 6 Months
|
7.03 units on a scale
Standard Deviation 2.6
|
6.77 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 6 weeks post enrollmentSecondary outcomes include use of cessation resources at 6 weeks post enrollment.
Outcome measures
| Measure |
SBIRT
n=377 Participants
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT: The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
|
Healthy Habits Control
n=373 Participants
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC: The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
|
|---|---|---|
|
Use of Cessation Resources at 6 Weeks
|
53 Percentage of caregivers
|
0 Percentage of caregivers
|
SECONDARY outcome
Timeframe: 6 months post enrollmentPopulation: Data were not collected.
Secondary outcomes include use of cessation resources at 6 months post enrollment.
Outcome measures
Outcome data not reported
Adverse Events
SBIRT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Habits Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Melinda Mahabee-Gittens
Cincinnati Children's Hospital Medical Center
Phone: 513-636-7966
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place