scholarly journals Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT)

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040117
Author(s):  
Carole Clair ◽  
Aurélie Augsburger ◽  
Priska Birrer ◽  
Isabella Locatelli ◽  
Joelle Schwarz ◽  
...  

IntroductionFew studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim of this study is to assess the efficacy of a smoking cessation intervention in a population of smokers with type 2 diabetes and to measure the metabolic impact of smoking cessation.Methods and analysisThe study is an open-label, randomised control trial. Participants recruited from a sanitary region of Switzerland will be randomly allocated to either the intervention or the control arm. The intervention group will have four individual counselling sessions over 12 weeks. Trained research nurses will conduct the behavioural intervention, using motivational interviews and addressing diabetes and gender specificities. The control group will have one short counselling session at baseline and will be given written information on smoking cessation. Both groups will have a follow-up visit at 26 and 52 weeks. Demographic and medical data will be collected at baseline and follow-up, along with blood and urine samples. The primary study outcome is continuous smoking abstinence validated by expired-air carbon monoxide from week 12 to week 52. Secondary study outcomes are continuous and 7-day point prevalence smoking abstinence at 12 and 26 weeks; change in motivation to quit and cigarette consumption; and change in glycosylated haemoglobin levels, body weight, waist circumference and renal function after smoking cessation. In a subsample of 80 participants, change in stool microbiota from baseline will be measured at 3, 8 and 26 weeks after smoking cessation.Ethics and disseminationEthical approval has been obtained by the competent ethics committee (Commission cantonale d’éthique de la recherche sur l’être humain, CER-VD 2017–00812). The results of the study will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numbersClinicalTrials.gov NCT03426423 and SNCTP000002762; Pre-results.

2020 ◽  
Vol 18 (2) ◽  
Author(s):  
Muhammad Adil Zainal Abidin ◽  
Hayati Kadir @ Shahar ◽  
Rosliza Abdul Manaf

Introduction: Carbon monoxide measurement is one of the biomedical risk assessments in smoking cessation. With the advancement in medical devices, risk assessment among smoker using carbon monoxide can be an effective intervention for quit smoking. A systematic review was conducted on the effectiveness of using carbon monoxide measurement in smoking cessation intervention. Material and methods: A systematic review and narrative synthesis were done using PRISMA guideline. A broad database search on English literature was conducted including Medline, PubMed, Scopus and Science Direct from 2008 till 2017. Additional studies were also searched through snowballing technique by searching the bibliographies of selected studies. Five studies met the criteria with two studies were done in clinical settings while the other was done at population settings. The studies were conducted in the United States of America, United Kingdom and South Korea. All study were two-arm randomized controlled trials with variation in the outcome measurement mainly intention to quit, quit attempt and smoking abstinence. There was also variation in the duration of follow up ranging from 1 week to 12 months. Results: Only three studies found statistically significant increased in motivation or intention to quit smoking but only at 1 month follow up. All five study found no significant difference in frequency of quit attempt or smoking abstinence. Most of the studies recruited participants based on voluntary participation thus limiting the generalizability of the results. Conclusions: The present review has found limited studies on the effect of carbon monoxide measurement intervention for quit smoking. It may only be beneficial at the motivational level and not translated into behavioural changes. However, the effect too was short term and not sustained in the long term.


10.2196/18071 ◽  
2020 ◽  
Vol 9 (9) ◽  
pp. e18071 ◽  
Author(s):  
Jinsong Chen ◽  
Elsie Ho ◽  
Yannan Jiang ◽  
Robyn Whittaker ◽  
Tingzhong Yang ◽  
...  

Background Approximately 2 million Chinese people die annually from tobacco-related diseases, mostly men; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation advice or support. A social network–based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention) is designed to help Chinese male smokers to quit smoking. Objective This paper aims to present the protocol of a study examining the preliminary effectiveness of SCAMPI by comparing the prolonged abstinence rate of a group of users with a comparator group during a 6-week follow-up period. Methods A two-arm pilot randomized controlled trial was conducted to assess the preliminary effectiveness and acceptability of the SCAMPI program as a smoking cessation intervention. After initial web-based screening, the first 80 eligible individuals who had gone through the required registration process were registered as participants of the trial. Participants were randomly allocated to the intervention group (n=40) and the control group (n=40). Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users. The program delivers a range of smoking cessation approaches, including helping users to make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, providing information about smoking harms, motivational messages to help users overcome urges, providing standardized tests to users for assessing their levels of nicotine dependence and lung health, and providing a platform to encourage social support between users. Participants in the control group used the restricted version of the SCAMPI program (placebo app). Results Recruitment for this project commenced in January 2019 and proceeded until March 2019. Follow-up data collection was commenced and completed by June 2019. The primary outcome measure of the study was the 30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test). The secondary outcome measures of the study included participants’ cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants’ 7-day smoking abstinence at 4-week and 6-week follow-up (self-reported), participants’ 30-day smoking abstinence at 6-week follow-up (self-reported data only), and participants’ acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire). Conclusions If the SCAMPI program is shown to be preliminary effective, the study will be rolled out to be a future trial with a larger sample size and longer follow-up (6 months) to identify if it is an effective social network–based tool to support Chinese male smokers to quit smoking. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381 International Registered Report Identifier (IRRID) RR1-10.2196/18071


2020 ◽  
Author(s):  
Jinsong Chen ◽  
Elsie Ho ◽  
Yannan Jiang ◽  
Robyn Whittaker ◽  
Tingzhong Yang ◽  
...  

BACKGROUND Approximately 2 million Chinese people die annually from tobacco-related diseases, mostly men; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation advice or support. A social network–based gamified smoking cessation intervention (<i>SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention</i>) is designed to help Chinese male smokers to quit smoking. OBJECTIVE This paper aims to present the protocol of a study examining the preliminary effectiveness of SCAMPI by comparing the prolonged abstinence rate of a group of users with a comparator group during a 6-week follow-up period. METHODS A two-arm pilot randomized controlled trial was conducted to assess the preliminary effectiveness and acceptability of the SCAMPI program as a smoking cessation intervention. After initial web-based screening, the first 80 eligible individuals who had gone through the required registration process were registered as participants of the trial. Participants were randomly allocated to the intervention group (n=40) and the control group (n=40). Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users. The program delivers a range of smoking cessation approaches, including helping users to make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, providing information about smoking harms, motivational messages to help users overcome urges, providing standardized tests to users for assessing their levels of nicotine dependence and lung health, and providing a platform to encourage social support between users. Participants in the control group used the restricted version of the SCAMPI program (<i>placebo app</i>). RESULTS Recruitment for this project commenced in January 2019 and proceeded until March 2019. Follow-up data collection was commenced and completed by June 2019. The primary outcome measure of the study was the 30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test). The secondary outcome measures of the study included participants’ cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants’ 7-day smoking abstinence at 4-week and 6-week follow-up (self-reported), participants’ 30-day smoking abstinence at 6-week follow-up (self-reported data only), and participants’ acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire). CONCLUSIONS If the SCAMPI program is shown to be preliminary effective, the study will be rolled out to be a future trial with a larger sample size and longer follow-up (6 months) to identify if it is an effective social network–based tool to support Chinese male smokers to quit smoking. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381 INTERNATIONAL REGISTERED REPORT RR1-10.2196/18071


2019 ◽  
Vol 17 (September) ◽  
Author(s):  
Yan Lin ◽  
Riitta Dlodlo ◽  
Qi Shu ◽  
Haoxiang Lin ◽  
Qin Huang ◽  
...  

Author(s):  
Charmaine Chan ◽  
Kristyn Kamke ◽  
Freda Assuah ◽  
Sherine El-Toukhy

Abstract Although text-messaging interventions are effective for smoking cessation, few target teens in the USA and little is known about their effectiveness. The purpose of this manuscript is to examine correlates of dropout, response to smoking status prompts, and abstinence rates among subscribers of SmokeFreeTeen, a free, publicly available text-messaging smoking cessation intervention sponsored by the National Cancer Institute’s SmokeFree.Gov initiative, on quit day through 1 month follow-up. In a sample of teens (N = 2,685), aged 13–19, we examined demographics, smoking frequency, cigarettes smoked per day, prequit intervention time (i.e., maximum of 14 days of prequit day preparation), and number of quit attempts as correlates of response and abstinence rates among program initiators (i.e., participants who reached quit day but dropped out on or before intervention end) and completers (i.e., participants who reached quit day and completed the intervention). We also conducted Cox regression analysis of time from quit day to dropout by daily and nondaily smoking status. Two-thirds (n = 1,733, 64.54%) dropped out before the intervention ended, with dropout rates peaking on quit day (n = 289, 13.10%). Response rate to smoking status prompts remained below 30% throughout the intervention. At intervention end and 1 month follow-up, abstinence was 2.63% and 2.55% among program initiators, whereas abstinence was 6.09% and 6.01% among program completers. Dropout, response, and abstinence rates did not consistently differ by subscriber characteristics. Prequit time was associated with decreased likelihood of dropping out (adjusted hazards ratio: 0.94, confidence interval [CI]: 0.93–0.95), responding to smoking status prompts (adjusted odds ratio [aOR]: 0.94, CI: 0.92–0.96), and being abstinent (aOR: 0.96, CI: 0.93–0.99) on quit day. Two or more quit attempts were associated with increased response (aOR: 1.61, CI: 1.16–2.23) and abstinence (aOR: 1.91, CI: 1.25–2.92) rates on Day 7. In a first assessment of SmokeFreeTeen outcomes, we document high dropouts and low response and abstinence rates. SmokeFreeTeen produced abstinence rates lower than comparable text-messaging interventions targeting teens and young adults. Improving SmokeFreeTeen’s reach, engagement, and effectiveness is needed.


1997 ◽  
Vol 11 (3) ◽  
pp. 198-207 ◽  
Author(s):  
Jeffrey S. Nevid ◽  
Rafael A. Javier

Purpose. The purpose of this study was to compare a culturally specific, multicomponent behavioral smoking cessation program for Hispanic smokers with a low-intensity, enhanced self-help control condition. Design. Participants who completed pretreatment assessment were randomly assigned to treatment conditions. Smoking status was evaluated at posttreatment, 6-month follow-up, and 12-month follow-up intervals. Setting. The study was based in predominantly Hispanic neighborhoods in Queens, New York. Participants. Ninety-three Hispanic smokers participated: 48 men and 45 women. Intervention. The multicomponent treatment involved a clinic-based group program that incorporated a culturally specific component consisting of videotaped presentations of culturally laden smoking-related vignettes. The self-help control program was enhanced by the use of an introductory group session and follow-up supportive telephone calls. Measures. Smoking outcomes were based on cotinine-validated abstinence and self-reported smoking rates. Predictors of abstinence were examined, including sociodemographic variables, smoking history, nicotine dependence, acculturation, partner interactions, reasons for quitting, self-efficacy, and linguistic competence. Results. Significant group differences in cotinine-validated abstinence rates in favor of the multicomponent group were obtained, but only at posttreatment. With missing data included and coded for nonabstinence, validated abstinence rates at posttreatment were 21% for the multicomponent group and 6% for the self-help group. At the 6-month follow-up, the rates were 13% for the multicomponent group and 9% for the self-help group. By the 12-month follow-up, the rates declined to 8% and 7% for the multicomponent and self-help groups, respectively. A dose-response relationship between attendance at group sessions and abstinence status was shown at posttreatment and 6-month follow-up intervals. Conclusions. The results of the present study failed to show any long-term benefit from use of a clinic-based, culturally specific multicomponent smoking cessation intervention for Hispanic smokers relative to a minimal-contact, enhanced self-help control.


2019 ◽  
Author(s):  
Alla Machulska ◽  
Kristian Kleinke ◽  
Tanja Joan Eiler ◽  
Armin Grünewald ◽  
Rainer Brück ◽  
...  

Abstract Background: Automatic tendencies to approach drug-related cues have been linked to the development and maintainance of harmful drug taking behavior. Recent studies have demonstrated that these automatic approach tendencies can be targeted directly by means of Cognitive Bias Modification (CBM) approaches. Moreover, changing those approach tendencies may enhance treatment outcomes. However, training and therapy effects tend to be rather small and adherence to the training might be impaired by time-consuming multiple lab-training sessions. Here, we present a protocol for a randomized control design to improve CBM training efficiency and facilitate access to the training by providing mobile phone-based training sessions at home to current smokers motivated to quit smoking. Methods: Participants (n = 100) are current smokers who smoke at least 6 cigarettes per day for at least 6 months and are willing to quit smoking. All participants attend a brief behavioral smoking cessation intervention (TAU) and are randomly assigned either to an experimental (TAU + training) or a control group. Participants in the experimental condition are given access to a training app aimed at retraining automatic approach biases for smoking cues. Participants are instructed to perform the app-training outside the laboratory context on a daily basis for 14 consecutive days. Participants in the control group do not receive the training. Primary outcome measures are changes in smoking-related approach biases and reductions in daily nicotine consumption as assessed at baseline, post-training and at a six-week follow-up. Secondary outcome measures include approach biases for alternative stimuli or smoking stimuli to which participants were not exposed during training, attentional and association biases, biochemical outcomes, and self-reported smoking behavior, also measured at three different time points (baseline, post-training, follow-up). After completion of the study, smokers in the control condition will receive access to the training app. Discussion: This RCT is the first to test the effectiveness of an app-based CBM intervention as an adjunct to a brief smoking cessation intervention in smokers motivated to quit smoking. The results of this study can inform future research in the optimisation and advancement of CBM treatment for addiction. Trial registration: Registered with Current Controlled Trials: study ID ISRCTN15690771. Registered on 20 November 2018; http://www.isrctn.com/ISRCTN15690771 Key words: Approach Bias, Cogitive Bias Modification, cigarette smoking, nicotine addiction, Randomized Control Trial, smartphone apps


10.2196/17522 ◽  
2020 ◽  
Vol 8 (10) ◽  
pp. e17522
Author(s):  
Jinsong Chen ◽  
Elsie Ho ◽  
Yannan Jiang ◽  
Robyn Whittaker ◽  
Tingzhong Yang ◽  
...  

Background Around 2 million Chinese people, mostly men, die annually from tobacco-related diseases; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation support. Objective This study aimed to test the preliminary effectiveness and feasibility for a mobile social network (WeChat)–based smoking cessation intervention (SCAMPI program) among Chinese male smokers. Methods Chinese male smokers aged 25-44 years were recruited online from WeChat, the most widely used social media platform in China. Individuals using other smoking cessation interventions or who lacked capacity to provide online informed consent were excluded. Participants were randomly assigned (1:1) to intervention or control groups. Neither participants nor researchers were masked to assignment. The trial was fully online. All data were collected via WeChat. The intervention group received access to the full-version SCAMPI program, a Chinese-language smoking cessation program based on the Behaviour Change Wheel framework and relevant cessation guidelines. Specific intervention functions used in the program include: planning to help users make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, information about smoking harms, motivational messages to help users overcome urges, standardized tests for users to assess their levels of nicotine dependence and lung health, as well as a social platform to encourage social support between users. The control group had access to a static WeChat page of contacts for standard smoking cessation care. Both groups received incentive credit payments for participating. The primary outcome was 30-day biochemically verified smoking abstinence at 6 weeks after randomization, with missing data treated as not quitting. Secondary outcomes were other smoking status measures, reduction of cigarette consumption, study feasibility (recruitment and retention rate), and acceptability of and satisfaction with the program. Results The program recorded 5736 visitors over a 13-day recruitment period. We recruited 80 participants who were randomly allocated to two arms (n=40 per arm). At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat. Biochemically verified smoking abstinence at 6 weeks was determined for 10 of 40 (25%) intervention participants and 2 of 40 (5%) control participants (RR=5, 95% CI 1.2-21.4, P=.03). In the intervention group, the calculator function, motivational messages, and health tests were underused (less than once per week per users). Participants rated their satisfaction with the intervention program as 4.56 out of 5.00. Conclusions Our program is a novel, accessible, and acceptable smoking cessation intervention for Chinese male smokers. A future trial with a greater sample size and longer follow-up will identify if it is as effective as these preliminary data suggest. Trial Registration ANZCTR registry, ACTRN12618001089224; https://tinyurl.com/y536n7sx International Registered Report Identifier (IRRID) RR2-18071


2013 ◽  
Vol 16 (4) ◽  
pp. 95-100
Author(s):  
Alexander Sergeevich Ametov ◽  
Fatima Totrazovna Abaeva

Aim.  To investigate the efficacy and safety of glimepiride as initial mono-therapy in type 2 diabetes patients (T2DM). Materials and Methods. This is a multi-center, open-label prospective observational study. 245 treatment-naive T2DM patients, who had not achieved glycemic goals on lifestyle therapy during first 12 weeks after the diagnosis, were enrolled in this study. Anti-diabetes treatment was initiated with glimepiride and continued during the 6-month follow-up period. Prescription of the initial dose (1 mg per day) and further dose adjustments were carried out by the attending physician in accordance with the glimepiride data sheet. Dynamics of HbA1c, fasting plasma glucose (FPG), 2 h postprandial blood glucose (2hPPG), weight and waist circumference, as well as the incidence of hypoglycemia were the evaluated parameters. Results. The baseline HbA1c (mean: 7.9?0.5%; female: 7.8?0.4% ; male: 8.0?0.6%) was significantly reduced at week 12 (mean 7.2?0.6%, p


Sign in / Sign up

Export Citation Format

Share Document