Background
Methods
Trial design
Participants
Usual care
The intervention
Main topic | Subtitles | Number of messagesa |
---|---|---|
Before the quit day (Having a plan of action) | Controlling the stimulus for smoking | 1 |
Having a plan of action | 2 | |
Suggesting the healthy behavior | 1 | |
Things to do before the quit day | 2 | |
Individual support from others | 1 | |
Total | 7 (Daily) | |
After the quit day (Preventing relapse) | Importance of self-rewarding | 4 |
Strategies to cope with nicotine withdrawal | 13 | |
Coping with stimuli for smoking | 13 | |
Changing the environment | 10 | |
Preventing relapse | 13 | |
Total | 53 (First month, daily; Second month, every other day; Third month, every 3 days) |
Sample size
Randomization
Blinding
Measures and outcomes
Primary outcome: abstinence rate at 1st month
Secondary outcomes
Control variables
Socio-demographic variables
Smoking status
Medical status
Therapy
Data collection
Development of the message contents
Analysis
Ethical issues
Results
Total | Intervention | Control | ||||
---|---|---|---|---|---|---|
n | %a | n | %a | n | %a | |
Gender (n = 132) | ||||||
Female | 52 | 39.4 | 16 | 36.4 | 36 | 40.9 |
Male | 80 | 60.6 | 28 | 63.6 | 52 | 59.1 |
Age (n = 132) | ||||||
18–24 | 13 | 9.8 | 4 | 9.1 | 9 | 10.2 |
25–34 | 41 | 31.1 | 12 | 27.3 | 29 | 33.0 |
35–44 | 32 | 24.2 | 12 | 27.3 | 20 | 22.7 |
45–54 | 30 | 22.7 | 12 | 27.3 | 18 | 20.5 |
55+ | 16 | 12.1 | 4 | 9.1 | 12 | 13.6 |
Marital status (n = 132) | ||||||
Not-married | 66 | 50.0 | 21 | 47.7 | 45 | 51.1 |
Married | 66 | 50.0 | 23 | 52.3 | 43 | 48.9 |
Education (n = 132) | ||||||
Secondary school and below | 30 | 22.7 | 6 | 13.6 | 24 | 27.3 |
High school and above | 102 | 77.3 | 38 | 86.4 | 64 | 72.7 |
Social class (n = 117) | ||||||
Unemployed | 11 | 9.4 | 1 | 2.6 | 10 | 12.8 |
Blue collar | 52 | 44.4 | 14 | 35.9 | 38 | 48.7 |
White collar | 50 | 42.7 | 22 | 56.4 | 28 | 35.9 |
Self employed | 4 | 3.4 | 2 | 5.1 | 2 | 2.6 |
Daily cigarette consumption (n = 132) | ||||||
≤ 10 | 14 | 10.6 | 2 | 4.5 | 12 | 13.6 |
11–20 | 64 | 48.5 | 22 | 50.0 | 42 | 47.7 |
21–30 | 32 | 24.2 | 14 | 31.8 | 18 | 20.5 |
> 30 | 22 | 16.7 | 6 | 13.6 | 16 | 18.2 |
Pack-years (n = 128) | ||||||
≤ 10 | 39 | 30.5 | 14 | 32.6 | 25 | 29.4 |
11–20 | 42 | 32.8 | 15 | 34.9 | 27 | 31.8 |
> 20 | 47 | 36.7 | 14 | 32.6 | 33 | 38.8 |
Quit attempts (n = 132) | ||||||
Yes | 23 | 17.4 | 6 | 13.6 | 17 | 19.3 |
No | 109 | 82.6 | 38 | 86.4 | 71 | 80.7 |
Nicotine dependence level (n = 132) | ||||||
Low | 14 | 10.6 | 3 | 6.8 | 11 | 12.5 |
Medium | 89 | 67.4 | 30 | 68.2 | 59 | 67.0 |
High | 29 | 22.0 | 11 | 25 | 18 | 20.5 |
Depression score (n = 130) | ||||||
Normal | 83 | 63.8 | 29 | 67.4 | 54 | 62.1 |
High | 47 | 36.2 | 14 | 32.6 | 33 | 37.9 |
CO value (n = 132) | ||||||
0–6 | 13 | 9.8 | 4 | 9.1 | 9 | 10.2 |
7–10 | 12 | 9.1 | 3 | 6.8 | 9 | 10.2 |
> 10 | 107 | 81.1 | 37 | 84.1 | 70 | 79.5 |
Concomitant disease (n = 132) | ||||||
No | 31 | 23.5 | 9 | 20.5 | 22 | 25 |
Yes | 101 | 76.5 | 35 | 79.5 | 66 | 75 |
Consulting physicians (n = 132) | ||||||
A | 27 | 20.5 | 9 | 20.5 | 18 | 20.5 |
B | 19 | 14.4 | 9 | 20.5 | 10 | 11.4 |
C | 26 | 19.7 | 8 | 18.2 | 18 | 20.5 |
D | 30 | 22.7 | 9 | 20.5 | 21 | 23.9 |
E | 30 | 22.7 | 9 | 20.5 | 21 | 23.9 |
Pharmacotherapy (n = 131) | ||||||
NRT | 48 | 36.6 | 9 | 20.9 | 39 | 44.3 |
Bupropion | 22 | 16.8 | 9 | 20.9 | 13 | 14.8 |
Varenicline | 13 | 9.9 | 4 | 9.3 | 9 | 10.2 |
Combinedb | 48 | 36.6 | 21 | 36.6 | 27 | 30.7 |
Model 1a | Model 2b, c | ||
---|---|---|---|
OR (95% CI) | OR (95% CI) | ||
First month follow up | |||
Group, n (%) | |||
Intervention | 29 (65.9%) | 2.85 (1.33–6.14)d | 3.51 (1.30–9.44)d |
Control (ref) | 36 (40.9%) | 1.00 | 1.00 |
Social class, n (%) | |||
Unemployed | 1 (9.1%) | 0.08 (0.01–0.66)d | 0.27 (0.25–2.91) |
Blue collar | 27 (51.9%) | 0.85 (0.38–1.88) | 1.07 (0.39–2.90) |
White collar (ref)f | 31 (57.4%) | 1.00 | 1.00 |
Depression score, mean (±SD) | 5.2 (±2.8) | 0.89 (0.80–0.99)d | 0.90 (0.78–1.04) |
Quit attempts, mean (±SD) | 3.0 (±2.0) | 1.39 (1.08–1.79)d | 1.32 (0.97–1.78) |
Third month follow up | |||
Group, n (%) | |||
Intervention | 22 (50.0%) | 2.34 (1.07–5.09)d | 2.50 (1.04–5.98)c |
Control (ref) | 27 (30.7%) | 1.00 | 1.00 |
Social class, n (%) | |||
Unemployed | 0 (0.0%)e | 0.15 (0.02–1.29)e | 0.42 (0.04–4.23)e |
Blue collar | 25 (48.1%) | 1.35 (0.59–3.07) | 1.94 (0.77–4.88) |
White collar (ref)f | 22 (40.7%) | 1.00 | 1.00 |
Depression score, mean (±SD) | 4.9 (±2.5) | 0.88 (0.78–0.99)d | 0.89 (0.78–1.02) |
Marital status, n (%) | |||
Married | 32 (48.5%) | 1.90 (0.82–4.38) | 1.61 (0.63–4.12) |
Not married (ref) | 17 (25.8%) | 1.00 | 1.00 |
6th month follow up | |||
Group, n(%) | |||
Intervention | 18 (40.9%) | 2.31 (1.03–5.16)d | 2.31 (1.03–5.16)d |
Control (ref) | 21 (23.9%) | 1.00 | 1.00 |
Intervention | Control (ref) | OR (95% CI) | |
---|---|---|---|
n (%)b | n (%)b | ||
First montha | |||
Adequate total follow-up (n = 132) | 23 (52.3) | 29 (33.0) | 2.45 (1.14–5.27)c |
Adequate telephone follow up (n = 132) | 34 (77.3) | 56 (63.6) | 1.97 (0.86–4.52) |
Adequate face-to-face follow up (n = 132) | 23 (52.3) | 26 (29.5) | 2.80 (1.30–6.04)c |
Medication continuity (n = 125) | 21 (50.0) | 29 (34.9) | 1.89 (0.88–4.04) |
Weight gain (n = 64)d | 12 (57.1) | 20 (55.6) | 1.07 (0.39–2.89) |
Third montha | |||
Adequate total follow-up (n = 132) | 22 (50.0) | 21 (23.9) | 3,53 (1.59–7.82)c |
Adequate telephone follow up (n = 132) | 4 (9.1) | 7 (8.0) | 1,13 (0.31–4.12) |
Adequate face-to-face follow up (n = 132) | 22 (50.0) | 26 (29.5) | 2,62 (1.21–5.70)c |
Medication continuity (n = 115) | 11 (27.5) | 8 (10.7) | 3,33 (1.19–9.29)c |
Weight gain (n = 64)d | 15 (53.6) | 19 (52.8) | 1,03 (0.38–2.78) |