Trial Outcomes & Findings for Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology (NCT NCT04172623)
NCT ID: NCT04172623
Last Updated: 2023-02-13
Results Overview
Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2023-02-13
Participant Flow
Participant milestones
| Measure |
Real-Time Smoking Intervention
Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
Real-Time Smoking Intervention: Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment.
|
Standard Treatment
Adult smokers will receive standard outpatient tobacco treatment.
Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-report data on sex was missing for N=4 participants, N=2 in each condition.
Baseline characteristics by cohort
| Measure |
Real-Time Smoking Intervention
n=29 Participants
Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
Real-Time Smoking Intervention: Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment.
|
Standard Treatment
n=29 Participants
Adult smokers will receive standard outpatient tobacco treatment.
Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 10.3 • n=29 Participants
|
57.9 years
STANDARD_DEVIATION 9.4 • n=29 Participants
|
56.0 years
STANDARD_DEVIATION 9.9 • n=58 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=27 Participants • Self-report data on sex was missing for N=4 participants, N=2 in each condition.
|
14 Participants
n=27 Participants • Self-report data on sex was missing for N=4 participants, N=2 in each condition.
|
31 Participants
n=54 Participants • Self-report data on sex was missing for N=4 participants, N=2 in each condition.
|
|
Sex: Female, Male
Male
|
10 Participants
n=27 Participants • Self-report data on sex was missing for N=4 participants, N=2 in each condition.
|
13 Participants
n=27 Participants • Self-report data on sex was missing for N=4 participants, N=2 in each condition.
|
23 Participants
n=54 Participants • Self-report data on sex was missing for N=4 participants, N=2 in each condition.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=29 Participants • Self-reported ethnicity data were missing for N=4 participants, N=2 in each condition.
|
5 Participants
n=29 Participants • Self-reported ethnicity data were missing for N=4 participants, N=2 in each condition.
|
8 Participants
n=58 Participants • Self-reported ethnicity data were missing for N=4 participants, N=2 in each condition.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=29 Participants • Self-reported ethnicity data were missing for N=4 participants, N=2 in each condition.
|
22 Participants
n=29 Participants • Self-reported ethnicity data were missing for N=4 participants, N=2 in each condition.
|
46 Participants
n=58 Participants • Self-reported ethnicity data were missing for N=4 participants, N=2 in each condition.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=29 Participants • Self-reported ethnicity data were missing for N=4 participants, N=2 in each condition.
|
2 Participants
n=29 Participants • Self-reported ethnicity data were missing for N=4 participants, N=2 in each condition.
|
4 Participants
n=58 Participants • Self-reported ethnicity data were missing for N=4 participants, N=2 in each condition.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=29 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=29 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=29 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=29 Participants
|
8 Participants
n=29 Participants
|
17 Participants
n=58 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=29 Participants
|
17 Participants
n=29 Participants
|
31 Participants
n=58 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=29 Participants
|
2 Participants
n=29 Participants
|
4 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=29 Participants
|
2 Participants
n=29 Participants
|
5 Participants
n=58 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=29 Participants
|
29 participants
n=29 Participants
|
58 participants
n=58 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups.
Outcome measures
| Measure |
Real-Time Smoking Intervention
n=29 Participants
Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
Real-Time Smoking Intervention: Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment.
|
Standard Treatment
n=29 Participants
Adult smokers will receive standard outpatient tobacco treatment.
Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment.
|
|---|---|---|
|
Change in Cigarettes
|
10.2 cigarettes per day
Standard Deviation 12.2
|
7.7 cigarettes per day
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Week 8Timeline follow-back data will be collected to determine the % of days abstinent from cigarettes.
Outcome measures
| Measure |
Real-Time Smoking Intervention
n=29 Participants
Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
Real-Time Smoking Intervention: Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment.
|
Standard Treatment
n=29 Participants
Adult smokers will receive standard outpatient tobacco treatment.
Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment.
|
|---|---|---|
|
% Days Abstinent From Cigarettes
|
12.4 percentage of days
Standard Deviation 27.2
|
6.9 percentage of days
Standard Deviation 14.6
|
Adverse Events
Real-Time Smoking Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Treatment
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place