The Effectiveness of Smoking Cessation in Prediabetic Smokers

Summary

Participation Requirements

Description

The assignment of this trial is based on preference-based shared decision-making. Participants: We recruit study participants at National Taiwan University Hospital and its Yunlin branch. All participants gave informed consent, with personal data protected. Only individuals aged 30 to 75 years are i...

The assignment of this trial is based on preference-based shared decision-making. Participants: We recruit study participants at National Taiwan University Hospital and its Yunlin branch. All participants gave informed consent, with personal data protected. Only individuals aged 30 to 75 years are included. A history of diabetes, hypertension, FTND, alcohol consumption, physical activity, depression, sleep quality, and current medications is collected through standardized personal interviews. Prediabetic participants are those repeatedly having either of the following: 1) plasma glucose 100 to 125 mg/dL (5.6 to 6.9 mmol/L) in the fasting state; 2) plasma glucose 140 to 199 mg/dL (7.8 to 11.0 mmol/L) two hours after a 75-g oral glucose load; 3) glycosylated hemoglobin (A1C) 5.7% to 6.4%, in the absence of diabetic medications. Prediabetic participants who smoke ?10 CPD for at least 6 months are classified as prediabetic smokers. Excluded are those with existing diagnosis of DM, thyroid diseases, acute cardiac conditions within 3 months, acute renal failure, chronic glomerulonephritis, polycystic kidney disease, mental health disorders ever diagnosed by psychiatrists, pregnancy, breast-feeding, malignancy; or current use of diabetic medications, smoking cessation medications, steroids, lithium or antipsychotics. The study protocol was approved by the National Taiwan University Hospital Research Ethics Committee. Program and post-program abstinence: At baseline, all prediabetic smokers were asked if they want to join the Fight Tobacco and Stay Fit (FIT2) program. Participants who decided to receive the FIT2 program were referred to smoking cessation clinics at National Taiwan University Hospital and its Yunlin Branch. Participants in this group could receive their medications up to 16 weeks within one year. Each participant also received counseling for individualized techniques for smoking cessation and body weight control at each visit. We do not prescribe nicotine replacement therapy (NRT) because it may induce insulin resistance and confound our study outcome. Bupropion is not available for smoking cessation in our institutions. Varenicline users are encouraged either to set their quit day 8 days after starting the medication; or to freely choose quit day at any time between Days 8 and 35 after starting treatment (i.e., following drug titration that took place within the first week). Varenicline users are also forbidden to use NRT during the study period. The varenicline prescription adheres to regulations by the Health Promotion Administration, Ministry of Health and Welfare, Taiwan (www.hpa.gov.tw) and manufacturer's directions, usually initiated at 0.5 mg once daily for the first three days then increased to 1 mg once daily. From day 8 to up to 16 weeks, the recommended dose is 1 mg varenicline twice daily. During the therapy course, physicians are allowed to adjust varenicline dosage according to tolerability. Drug adverse events, withdrawal symptoms, and perceived barriers to quitting should be recorded and addressed. Physicians should emphasize that if there are any uncontrolled depressed moods, suicidal thoughts, or attempts, they are to cease varenicline treatment and consult a psychiatrist immediately. At the end of the program, smoking status is assessed by self-reported 7-day point-prevalence abstinence, confirmed by a breath CO level of less than 3 ppm. Cotinine is not used to assess abstinence because, when used with self-report to indicate whether a person has smoked, CO and cotinine levels show high agreement. We provide participants in the intervention group with individualized counseling to help minimize the relapse rate. In addition to smoking cessation techniques, individualized weekly coaching and instruction about diet and physical activity at each visit are conducted to restrict PCWG. Emphasis is placed on checking the diary for body weight, food, and physical activity. For those who gained weight, more intensive ways of calorie restriction and physical activity (at least 200 minutes per week) are instructed. The counseling sessions also allowed opportunities to identify obstacles to lifestyle change and to discuss behavioral approaches. Post-program smoking status is established at six months by self-reported 7-day point prevalence of abstinence and a breath carbon monoxide level. Post-program quitters are those who quit successfully after the intervention and maintained their non-smoking status at six months (post-program abstinence). Participants who fail to stop smoking after the intervention are reassigned to the control group. Those who relapse after six months are still classified as post-program quitters. Usual care and control: Usual care is provided for prediabetic smokers who decided not to receive the FIT2 program. Usual care comprises encouragement to quit smoking and initiate a therapeutic lifestyle change at each visit. In the time-varying analysis, the control group contains participants from the intervention group who fail to achieve post-program abstinence and all participants receiving usual care, including those who quit smoking on their own. Given that post-program smoking status is established at six months after enrollment, for the time-varying analysis, the control group also includes all post-program quitters during the first six months to reduce immortal time bias.

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