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The effects of dietary instruction on cardiovascular risk markers after smoking cessation: study protocol for a multicenter randomized controlled trial in Japan.

ABSTRACT: BACKGROUND:Weight gain frequently occurs after smoking cessation (SC); the risk of new-onset diabetes mellitus increases for several years after SC. However, no large-scale, randomized controlled trials have examined the effects of nutritional guidance on post-SC cardiovascular risk. The current trial will enroll individuals who successfully quit smoking with the help of a SC clinic and who gain weight, to determine the effects of nutritional guidance on cardiovascular, glucose, and lipid metabolism biomarkers. METHODS/DESIGN:This is a multicenter, prospective, parallel-group, randomized controlled trial. Some 250 individuals who successfully quit smoking with the help of a SC clinic and who gain weight (an increase of ??1.25% Body Mass Index (BMI) between the first and the fifth visit to the SC clinic) will be enrolled within 1 month of the final (fifth) visit to the SC clinic. These participants will be randomly assigned to an intervention group (125 individuals receiving nutritional guidance) or a control group (125 individuals not receiving nutritional guidance). A registered dietitian will provide nutritional guidance once every 3 months for a total of three sessions. The primary endpoint for this trial will be the level of adiponectin, a predictor of cardiovascular risk that reflects weight and smoking status. Secondary endpoints will be levels of cardiovascular, glucose, and lipid metabolism biomarkers, BMI, abdominal circumference, and the percentage of individuals who quit smoking for a prolonged period. DISCUSSION:This trial will determine the benefits of nutritional guidance with respect to post-SC weight gain. The findings should provide useful information for devising a quality protocol for SC education to prevent cardiovascular disease. TRIAL REGISTRATION:The study is registered at the University Hospital Medical Information Network Clinical Trials Registry ( UMIN000030282 ). Registered on 6 December 2017.

SUBMITTER: Komiyama M

PROVIDER: S-EPMC6172844 | biostudies-other | 2018 Oct

REPOSITORIES: biostudies-other

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The effects of dietary instruction on cardiovascular risk markers after smoking cessation: study protocol for a multicenter randomized controlled trial in Japan.

Komiyama Maki M Ozaki Yuka Y Wada Hiromichi H Yamakage Hajime H Satoh-Asahara Noriko N Morimoto Tatsuya T Shimatsu Akira A Takahashi Yuko Y Hasegawa Koji K

Trials 20181004 1

<h4>Background</h4>Weight gain frequently occurs after smoking cessation (SC); the risk of new-onset diabetes mellitus increases for several years after SC. However, no large-scale, randomized controlled trials have examined the effects of nutritional guidance on post-SC cardiovascular risk. The current trial will enroll individuals who successfully quit smoking with the help of a SC clinic and who gain weight, to determine the effects of nutritional guidance on cardiovascular, glucose, and lipi ...[more]

PMID: 30286787

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Project description:The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed.This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect.This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice.Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.

Dataset Information

The effects of dietary instruction on cardiovascular risk markers after smoking cessation: study protocol for a multicenter randomized controlled trial in Japan.

Publications

The effects of dietary instruction on cardiovascular risk markers after smoking cessation: study protocol for a multicenter randomized controlled trial in Japan.

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