Trial Outcomes & Findings for Ecological Momentary Intervention of Implementation Intentions Delivered by Text Message to Reduce Cigarette Smoking (NCT NCT04967885)
NCT ID: NCT04967885
Last Updated: 2023-04-24
Results Overview
To evaluate the feasibility of this customized EMI-II intervention, the investigators will examine the proportion of study participants completing the two-week intervention period, Week 2 in the Immediate Intervention arm and week 4 in the Waitlist arm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
2 weeks
Results posted on
2023-04-24
Participant Flow
Participant milestones
| Measure |
Immediate Intervention
Participants in the Immediate Intervention condition will create their Implementation Intention (II) messages before the two-week EMA + EMI-II period begins. During the EMA + EMI-II period, participants will complete five daily EMAs, and they will also complete weekly assessments reporting their past week cigarette smoking as a distal outcome and rating intervention acceptability. Following the EMA + EMI-II period, participants will enter a two-week follow-up period. During this time, participants will not receive any messages, but will report past week smoking on a weekly basis.
Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
|
Waitlist
Participants randomized to the Waitlist control condition will begin with a two-week no intervention condition during which they will report past week smoking on a weekly basis but will not receive any other intervention components. At the end of the two-week waitlist control period, participants will begin the two-week EMA plus EMI-II period. During the EMA plus EMI-II active study period, participants will complete five daily EMAs and weekly assessments to report their past week cigarette smoking and rate intervention acceptability. No follow-up is planned for the wait list control condition.
Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
|
|---|---|---|
|
Week 1 Follow-Up
STARTED
|
39
|
41
|
|
Week 1 Follow-Up
COMPLETED
|
32
|
37
|
|
Week 1 Follow-Up
NOT COMPLETED
|
7
|
4
|
|
Week 2 Follow-Up
STARTED
|
39
|
41
|
|
Week 2 Follow-Up
COMPLETED
|
25
|
35
|
|
Week 2 Follow-Up
NOT COMPLETED
|
14
|
6
|
|
Week 3 Follow-Up
STARTED
|
39
|
41
|
|
Week 3 Follow-Up
COMPLETED
|
23
|
30
|
|
Week 3 Follow-Up
NOT COMPLETED
|
16
|
11
|
|
Week 4 Follow-Up
STARTED
|
39
|
41
|
|
Week 4 Follow-Up
COMPLETED
|
23
|
31
|
|
Week 4 Follow-Up
NOT COMPLETED
|
16
|
10
|
|
EMI-II Intervention
STARTED
|
39
|
41
|
|
EMI-II Intervention
COMPLETED
|
25
|
31
|
|
EMI-II Intervention
NOT COMPLETED
|
14
|
10
|
Reasons for withdrawal
| Measure |
Immediate Intervention
Participants in the Immediate Intervention condition will create their Implementation Intention (II) messages before the two-week EMA + EMI-II period begins. During the EMA + EMI-II period, participants will complete five daily EMAs, and they will also complete weekly assessments reporting their past week cigarette smoking as a distal outcome and rating intervention acceptability. Following the EMA + EMI-II period, participants will enter a two-week follow-up period. During this time, participants will not receive any messages, but will report past week smoking on a weekly basis.
Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
|
Waitlist
Participants randomized to the Waitlist control condition will begin with a two-week no intervention condition during which they will report past week smoking on a weekly basis but will not receive any other intervention components. At the end of the two-week waitlist control period, participants will begin the two-week EMA plus EMI-II period. During the EMA plus EMI-II active study period, participants will complete five daily EMAs and weekly assessments to report their past week cigarette smoking and rate intervention acceptability. No follow-up is planned for the wait list control condition.
Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
|
|---|---|---|
|
Week 1 Follow-Up
Lost to Follow-up
|
7
|
4
|
|
Week 2 Follow-Up
Lost to Follow-up
|
14
|
6
|
|
Week 3 Follow-Up
Lost to Follow-up
|
16
|
11
|
|
Week 4 Follow-Up
Lost to Follow-up
|
16
|
10
|
|
EMI-II Intervention
Lost to Follow-up
|
14
|
10
|
Baseline Characteristics
Ecological Momentary Intervention of Implementation Intentions Delivered by Text Message to Reduce Cigarette Smoking
Baseline characteristics by cohort
| Measure |
Immediate Intervention
n=39 Participants
Participants in the Immediate Intervention condition will create their Implementation Intention (II) messages before the two-week EMA + EMI-II period begins. During the EMA + EMI-II period, participants will complete five daily EMAs, and they will also complete weekly assessments reporting their past week cigarette smoking as a distal outcome and rating intervention acceptability. Following the EMA + EMI-II period, participants will enter a two-week follow-up period. During this time, participants will not receive any messages, but will report past week smoking on a weekly basis.
Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
|
Waitlist
n=41 Participants
Participants randomized to the Waitlist control condition will begin with a two-week no intervention condition during which they will report past week smoking on a weekly basis but will not receive any other intervention components. At the end of the two-week waitlist control period, participants will begin the two-week EMA plus EMI-II period. During the EMA plus EMI-II active study period, participants will complete five daily EMAs and weekly assessments to report their past week cigarette smoking and rate intervention acceptability. No follow-up is planned for the wait list control condition.
Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 1.5 • n=99 Participants
|
40.0 years
STANDARD_DEVIATION 1.7 • n=107 Participants
|
41.3 years
STANDARD_DEVIATION 1.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=99 Participants
|
41 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Cigarettes smoker per day
|
30.2 cigarettes smoked per day
STANDARD_DEVIATION 5.8 • n=99 Participants
|
30.3 cigarettes smoked per day
STANDARD_DEVIATION 7.2 • n=107 Participants
|
30.2 cigarettes smoked per day
STANDARD_DEVIATION 6.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeksTo evaluate the feasibility of this customized EMI-II intervention, the investigators will examine the proportion of study participants completing the two-week intervention period, Week 2 in the Immediate Intervention arm and week 4 in the Waitlist arm.
Outcome measures
| Measure |
Immediate Intervention
n=39 Participants
Participants in the Immediate Intervention condition will create their Implementation Intention (II) messages before the two-week EMA + EMI-II period begins. During the EMA + EMI-II period, participants will complete five daily EMAs, and they will also complete weekly assessments reporting their past week cigarette smoking as a distal outcome and rating intervention acceptability. Following the EMA + EMI-II period, participants will enter a two-week follow-up period. During this time, participants will not receive any messages, but will report past week smoking on a weekly basis.
Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
|
Waitlist
n=41 Participants
Participants randomized to the Waitlist control condition will begin with a two-week no intervention condition during which they will report past week smoking on a weekly basis but will not receive any other intervention components. At the end of the two-week waitlist control period, participants will begin the two-week EMA plus EMI-II period. During the EMA plus EMI-II active study period, participants will complete five daily EMAs and weekly assessments to report their past week cigarette smoking and rate intervention acceptability. No follow-up is planned for the wait list control condition.
Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
|
|---|---|---|
|
Percent of Participants Completing Intervention Period
|
25 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Includes participants who completed the AIM on the weekly surveys during the intervention period.
To examine the acceptability of the EMI-II intervention, participants will rate the acceptability of the intervention on a Likert scale ranging from 1 (low acceptability) to 5 (high acceptability) on the two weekly surveys completed during the intervention period.
Outcome measures
| Measure |
Immediate Intervention
n=24 Participants
Participants in the Immediate Intervention condition will create their Implementation Intention (II) messages before the two-week EMA + EMI-II period begins. During the EMA + EMI-II period, participants will complete five daily EMAs, and they will also complete weekly assessments reporting their past week cigarette smoking as a distal outcome and rating intervention acceptability. Following the EMA + EMI-II period, participants will enter a two-week follow-up period. During this time, participants will not receive any messages, but will report past week smoking on a weekly basis.
Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
|
Waitlist
n=28 Participants
Participants randomized to the Waitlist control condition will begin with a two-week no intervention condition during which they will report past week smoking on a weekly basis but will not receive any other intervention components. At the end of the two-week waitlist control period, participants will begin the two-week EMA plus EMI-II period. During the EMA plus EMI-II active study period, participants will complete five daily EMAs and weekly assessments to report their past week cigarette smoking and rate intervention acceptability. No follow-up is planned for the wait list control condition.
Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
|
|---|---|---|
|
Average Acceptability of the EMI-II Intervention
|
3.85 score on a scale
Standard Deviation 0.84
|
3.55 score on a scale
Standard Deviation 0.97
|
PRIMARY outcome
Timeframe: 2 weeksSelf-reported cigarette smoking will be assessed five times per day (morning, late morning, early afternoon, late afternoon, evening) during the intervention period. Participants will respond via text messaging to the question, "Since the last prompt, how many cigarettes have you smoked?"
Outcome measures
| Measure |
Immediate Intervention
n=22 Participants
Participants in the Immediate Intervention condition will create their Implementation Intention (II) messages before the two-week EMA + EMI-II period begins. During the EMA + EMI-II period, participants will complete five daily EMAs, and they will also complete weekly assessments reporting their past week cigarette smoking as a distal outcome and rating intervention acceptability. Following the EMA + EMI-II period, participants will enter a two-week follow-up period. During this time, participants will not receive any messages, but will report past week smoking on a weekly basis.
Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
|
Waitlist
n=28 Participants
Participants randomized to the Waitlist control condition will begin with a two-week no intervention condition during which they will report past week smoking on a weekly basis but will not receive any other intervention components. At the end of the two-week waitlist control period, participants will begin the two-week EMA plus EMI-II period. During the EMA plus EMI-II active study period, participants will complete five daily EMAs and weekly assessments to report their past week cigarette smoking and rate intervention acceptability. No follow-up is planned for the wait list control condition.
Ecological Momentary Implementation Intentions Intervention (EMI-II): To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
|
|---|---|---|
|
Rate of Self-reported Cigarette Smoking
|
30.3 cigarettes smoked per day
Standard Deviation 7.1
|
30.1 cigarettes smoked per day
Standard Deviation 5.0
|
Adverse Events
Immediate Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist
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