The Effectiveness of Smoking Cessation in Prediabetic Smokers
NCT ID: NCT01926041
Last Updated: 2025-06-24
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
589 participants
INTERVENTIONAL
2013-08-01
2027-12-31
Brief Summary
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Combing the need for smoking cessation and body weight self-management to prevent the progression of prediabetes stage into DM, with the public implementation of the second-generation cessation program, we aimed to study the effectiveness of the Fight Tobacco and Stay Fit (FIT2) program aiming at promoting smoking cessation and restricting post-cessation weight gain (PCWG) together in prediabetic smokers regarding long-term glycemic and DM-related health outcomes.
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Detailed Description
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We expect to recruit study participants at National Taiwan University Hospital and its Yunlin branch, where a systematic identification system has been applied to classify the tobacco addiction status of every patient in outpatient clinics. This study invites identified current smokers to undergo screening tests between August 2013 to January 2017. All participants should give informed consent, with personal data protected. Only individuals aged 30 to 75 years are included. A history of diabetes, hypertension, Fagerström test for nicotine dependence, alcohol consumption, physical activity, depression, sleep quality, and current medications is collected through standardized personal interviews. Prediabetic participants are those who repeatedly have 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. Information about tobacco use, alcohol consumption, physical activity, depression, sleep quality, personal medical histories, and current medications is collected through standardized personal interviews and medical records. The study protocol was approved by the National Taiwan University Hospital Research Ethics Committee.
Sample size estimation We estimate to recruit at least 596 prediabetic smokers, 33% (199) of whom decide to join the intervention, to reach 90% power and a two-sided 95% CI for the detection of a 50% risk reduction, assuming 30% as the risk of incident T2D during follow-up in the usual care group.
Assignment, prospective follow-up, and analytic design The assignment of this trial is based on shared decision-making. At baseline, all eligible prediabetic smokers are asked if they would like to join the Fight Tobacco and Stay Fit (FIT2) program or just receive usual care. Beginning at enrollment, the smoking status, breath carbon monoxide levels, anthropometric indices, automated office and home blood pressures, and blood tests were recorded every six months. The intention-to-treat analysis is performed among all participants joining the FIT2 program and receiving usual care. The modified per-protocol analysis is adopted to compare participants with documented abstinence at prespecified study ends (e.g., 10 years) with the controls.
The FIT2 program and post-program abstinence:
The FIT2 program is a 16-week smoking cessation program that combines varenicline prescription with individualized counseling on not only smoking cessation but also weight control techniques. Participants in this group can receive their medications for 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 and 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.
Smoking status is assessed by self-reported 7-day point-prevalence abstinence, confirmed by a breath CO level. 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 varenicline prescription and smoking cessation counseling covered in conventional smoking cessation services, the FIT2 program also offers individualized weekly behavior coaching in diet and physical activity to restrict PCWG. The FIT2 participants are encouraged to do at least 150 minutes of moderate-intensity (3.0-6.0 metabolic equivalents) aerobic physical activity throughout the week. The counseling sessions allow opportunities to identify obstacles to lifestyle change and to discuss approaches with a professional panel of dietitians and certified personal trainers. The FIT2 participants are encouraged to do at least 150 minutes of moderate-intensity (3.0-6.0 metabolic equivalents) aerobic physical activity throughout the week. Emphasis is placed on checking the weekly diary for body weight, food, and physical activity through protected cellphone messages between participants and the assigned panel professionals. For those who gain weight, more intensive ways of calorie restriction and physical activity (at least 300 minutes of moderate-intensity aerobic physical activity per week) are instructed.
Post-program smoking status is recorded weekly from 16 weeks to six months by self-reported 7-day point prevalence of abstinence and a breath carbon monoxide level of \<6 ppm. Post-program quitters are those who quit successfully at 16 weeks after the FIT2 program and maintain their non-smoking status until the prespecified study ends (e.g., post-program abstinence at 10 years). For the modified per-protocol analysis, participants who fail to keep quit after the FIT2 program are reassigned to the control group.
Usual care and control:
Usual care is provided for prediabetic smokers who decide not to receive the FIT2 program. Usual care comprises encouragement to quit smoking and initiate a therapeutic lifestyle change at each visit. In the modified per-protocol analysis, the control group contains participants joining the FIT2 program who fail to achieve post-program abstinence and all participants receiving usual care, including those who quit smoking on their own.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention
A 16-week FIT2 program that combines smoking cessation therapy with individualized behavior coaching in diet and physical activity for PCWG restriction.
Varenicline for tobacco smoking cessation
The 16-week varenicline course conforms to real-practice government regulations in Taiwan.
Individualized counseling about both smoking cessation and weight control techniques
The FIT2 program also offers behavior coaching in diet and physical activity to restrict post-cessation weight gain, which is not covered in conventional smoking cessation services.
Control
Usual care
No interventions assigned to this group
Interventions
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Varenicline for tobacco smoking cessation
The 16-week varenicline course conforms to real-practice government regulations in Taiwan.
Individualized counseling about both smoking cessation and weight control techniques
The FIT2 program also offers behavior coaching in diet and physical activity to restrict post-cessation weight gain, which is not covered in conventional smoking cessation services.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prediabetic smokers
Exclusion Criteria
* thyroid diseases
* acute cardiac conditions within 3 months
* acute renal failure, chronic glomerulonephritis, or polycystic kidney disease
* mental health disorders ever diagnosed by psychiatrists
* pregnancy or breast-feeding
* malignancy
* current use of smoking cessation medications, steroids, lithium, or antipsychotics.
30 Years
75 Years
ALL
No
Sponsors
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Ministry of Science and Technology, Taiwan
OTHER_GOV
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chien-Hsieh Chiang, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital and its Yunlin branch
Taipei, Department of Family Medicine, Taiwan
Countries
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References
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Clair C, Rigotti NA, Porneala B, Fox CS, D'Agostino RB, Pencina MJ, Meigs JB. Association of smoking cessation and weight change with cardiovascular disease among adults with and without diabetes. JAMA. 2013 Mar 13;309(10):1014-21. doi: 10.1001/jama.2013.1644.
Bergman BC, Perreault L, Hunerdosse D, Kerege A, Playdon M, Samek AM, Eckel RH. Novel and reversible mechanisms of smoking-induced insulin resistance in humans. Diabetes. 2012 Dec;61(12):3156-66. doi: 10.2337/db12-0418. Epub 2012 Sep 10.
Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
Cropsey KL, Eldridge GD, Weaver MF, Villalobos GC, Stitzer ML. Expired carbon monoxide levels in self-reported smokers and nonsmokers in prison. Nicotine Tob Res. 2006 Oct;8(5):653-9. doi: 10.1080/14622200600789684.
Rennard S, Hughes J, Cinciripini PM, Kralikova E, Raupach T, Arteaga C, St Aubin LB, Russ C; Flexible Quit Date Study Group. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Nicotine Tob Res. 2012 Mar;14(3):343-50. doi: 10.1093/ntr/ntr220. Epub 2011 Nov 11.
Chiang CH, Yang HI, Jen CL, Lu SN, Wang LY, You SL, Su J, Iloeje UH, Chen CJ; REVEAL-HBV Study Group. Association between obesity, hypertriglyceridemia and low hepatitis B viral load. Int J Obes (Lond). 2013 Mar;37(3):410-5. doi: 10.1038/ijo.2012.63. Epub 2012 Apr 24.
Chiang CH, Lai JS, Hung SH, Lee LT, Sheu JC, Huang KC. Serum adiponectin levels are associated with hepatitis B viral load in overweight to obese hepatitis B virus carriers. Obesity (Silver Spring). 2013 Feb;21(2):291-6. doi: 10.1002/oby.20000.
Chiang CH, Lee LT, Hung SH, Lin WY, Hung HF, Yang WS, Sung PK, Huang KC. Opposite association between diabetes, dyslipidemia, and hepatocellular carcinoma mortality in the middle-aged and elderly. Hepatology. 2014 Jun;59(6):2207-15. doi: 10.1002/hep.27014. Epub 2014 Apr 3.
Chiang CH, Huang KC. Association between metabolic factors and chronic hepatitis B virus infection. World J Gastroenterol. 2014 Jun 21;20(23):7213-6. doi: 10.3748/wjg.v20.i23.7213.
Chiang CH, Huang KC. Reply: To PMID 24425422. Hepatology. 2015 May;61(5):1763-4. doi: 10.1002/hep.27427. Epub 2015 Mar 23. No abstract available.
Chang PH, Chiang CH, Ho WC, Wu PZ, Tsai JS, Guo FR. Combination therapy of varenicline with nicotine replacement therapy is better than varenicline alone: a systematic review and meta-analysis of randomized controlled trials. BMC Public Health. 2015 Jul 22;15:689. doi: 10.1186/s12889-015-2055-0.
Chiang CH, Lu CW, Han HC, Hung SH, Lee YH, Yang KC, Huang KC. The Relationship of Diabetes and Smoking Status to Hepatocellular Carcinoma Mortality. Medicine (Baltimore). 2016 Feb;95(6):e2699. doi: 10.1097/MD.0000000000002699.
Chiang CH, Sheu YH, Guo FR, Lin WW, Chen GR, Huang KC. Incorporating Post-Cessation Weight-Control Coaching into Smoking Cessation Therapy to Reduce Type 2 Diabetes Risk. Nutrients. 2021 Sep 25;13(10):3360. doi: 10.3390/nu13103360.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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201303041RINB
Identifier Type: -
Identifier Source: org_study_id
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