<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="other" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.134090.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Study Protocol</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>Comparative evaluation of transtheoretical model, multi theory model and hybrid theory model on the efficacy in smoking cessation among smokers: protocol for a cluster randomized interventional study.</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: awaiting peer review]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>paul madhu</surname>
                        <given-names>priyanka</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Software</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0003-3917-2742</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Zahiruddin</surname>
                        <given-names>Quazi Syed</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0001-5875-8277</uri>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>wankhede</surname>
                        <given-names>Anand</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Software</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a3">3</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>public health dentistry, datta meghe institute of higher education and research, wardha, maharashtra, 442001, India</aff>
                <aff id="a2">
                    <label>2</label>department of community medicine, datta megheinstitute of higher education and research, wardha, maharashrra, 442001, India</aff>
                <aff id="a3">
                    <label>3</label>department of periodontology, datta meghe institute of higher education and research, wardha, maharashtra, 442001, India</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:drpriyanka0690@gmail.com">drpriyanka0690@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>17</day>
                <month>8</month>
                <year>2023</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2023</year>
            </pub-date>
            <volume>12</volume>
            <elocation-id>997</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>8</day>
                    <month>6</month>
                    <year>2023</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2023 paul madhu p et al.</copyright-statement>
                <copyright-year>2023</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/12-997/pdf"/>
            <abstract>
                <p>
                    <bold>Background</bold>: Consumption of tobacco all over the world is considered to create morbidity and mortality that could be potentially preventable. Tobacco is said to be the major cause for non-communicable disease all over the world. Mortality because of NCDs responsible for about 63%. Total 80% of the deaths related to tobacco occur in the Low- and Middle-Income Countries throughout the world.</p>
                <p>
                    <bold>Aim</bold>: This protocol will aid in conduct of research to assess and compare the efficacy of Multi theory Model and Modified Multi theory model as against Transtheoretical model</p>
                <p>
                    <bold>Methods</bold>: The research will be carried out in a primary health care facility. The study design is three arm parallel cluster randomized interventional trial and cluster sampling method has been selected. The sample size has been calculated to 240 i.e 80 in each group. The Study will be conducted in primary health centre of the university for conducting community-based projects. The personnel at the main health centre will create the allotment sequence, register candidates, and allocate people to interventions Participant Identification Form, Fagerstrom Test for Nicotine Dependence, Smoking Abstinence Scale, and urine cotinine level will be used to collect data. In- person interviews will be conducted by the researcher for assessing the data. Following the completion of the trainings, post-test data was obtained by handling all data collecting instruments, including the Fagerstrom Test for Nicotine Dependence, the Smoking Abstinence Scale, and urine cotinine level. Participant Identification Form: the form, which was prepared by the researcher in line with the related literature, included 16 questions.</p>
                <p>
                    <bold>Expected Outcome</bold>: On overcoming the limitations of transtheoretical model by conducting theory comparison and multiple-behavior research can prove to be a better approach for smoking cessation to the community.</p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Smoking cessation</kwd>
                <kwd>smokeless tobacco</kwd>
                <kwd>transtheoretical model</kwd>
                <kwd>multitheory model</kwd>
            </kwd-group>
            <funding-group>
                <funding-statement>The author(s) declared that no grants were involved in supporting this work.</funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec id="sec1" sec-type="intro">
            <title>Introduction</title>
            <p>Consumption of tobacco all over the world is considered to create morbidity and mortality that could be potentially preventable.
                <sup>
                    <xref ref-type="bibr" rid="ref1">1</xref>
                </sup> Tobacco is said to be the major cause for non-communicable disease all over the world. Mortality because of NCDs responsible for about 63%.
                <sup>
                    <xref ref-type="bibr" rid="ref2">2</xref>
                </sup> 80 percent of the deaths related to tobacco occur in the Low and Middle Income Countries throughout the world.
                <sup>
                    <xref ref-type="bibr" rid="ref3">3</xref>
                </sup> According to WHO, mortality due to the diseases that are connected to tobacco has increased from 1.4% in 1990 to 13.3% in 2020.
                <sup>
                    <xref ref-type="bibr" rid="ref4">4</xref>
                </sup> Deaths associated to tobacco in India by 2020 is evaluated to be 1.5 million.
                <sup>
                    <xref ref-type="bibr" rid="ref5">5</xref>
                </sup> The two main forms of consuming tobacco are smoking and smokeless tobacco.</p>
            <p>In our country, tobacco consumption has become challenging and a complex issue, with a wide range of smoking forms as well as smokeless tobacco product. Tobacco usage is prevalent and practised in India in a variety of ways. Tobacco use is increasing at a rate of 2% to 3% each year, and it is estimated that smoking is responsible for 13% of all demises in the country. Our country is currently representing a steadfast commitment for combating the tobacco problem by developing a wide-ranging control scheme that includes a variety of demand and supply reduction techniques. The anti-tobacco legislation in our country, which was initially adopted at the national level in 1975, was mostly restricted to health warnings and proved ineffective.
                <sup>
                    <xref ref-type="bibr" rid="ref5">5</xref>
                </sup> The &#x2018;Cigarettes and Other Tobacco Products Bill, 2003&#x2019; was a significant step forward in tobacco control legislation. Innovative means of mobilising human and financial resources for tobacco control, the establishment of effective national coordinating mechanisms, the integration of tobacco control into health and development programmes, and the periodic evaluation of these activities are all critical.
                <sup>
                    <xref ref-type="bibr" rid="ref6">6</xref>
                </sup>
                <sup>,</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref7">7</xref>
                </sup>
            </p>
            <p>Cigarette smoking degrades a smoker&#x2019;s health since it damages several organs in the body and can lead to a variety of ailments. Smoking is accountable for about 85% of lung cancer cases. Smoking can lead to around 85% of lung cancers and majority of cancer deaths are due to tobacco consumption. Cardiovascular events may take place as a consequence of smoking and altering this behaviour would lead to better health outcomes. Cessation of smoking serves to be beneficial for health and these benefits include lessening of morbidity and mortality caused due to smoking, progression of current illness gets slow, improved functioning etc.
                <sup>
                    <xref ref-type="bibr" rid="ref8">8</xref>
                </sup>
            </p>
            <p>In spite of the promise of public health interventions to help smokers quit, their effectiveness and application in different settings are limited. Using a computer-tailored smoking prevention intervention web-based, for instance, has proven to significantly promote quitting smoking. Although the current program is good for promoting smoking cessation initiation, it hasn&#x2019;t been shown to sustain quitting of smoking beyond six months, and its complex design can make it difficult for it to be widely implemented. Additionally, most interventions focus primarily on assisting with beginning of smoking cessation behaviors, while paying less focus on maintaining those behaviors. An experience smoking intervention based on dissonance appears to be successful in strengthening the desire to quit. Nevertheless, it doesn&#x2019;t seem to be successful in helping people quit the desire to smoke for the long term.
                <sup>
                    <xref ref-type="bibr" rid="ref9">9</xref>
                </sup> Bailey 
                <italic toggle="yes">et al.</italic> found that no medication therapy they looked at could be utilised to significantly promote smoking cessation over time. When it comes to long period maintenance of quitting smoking, very few modalities have been found to be effective. Smoking is based on both operant and classical conditioning processes. If conditioning is stopped in time, smoking cessation is possible. Behavioral changes are therefore required in order to stop smoking.
                <sup>
                    <xref ref-type="bibr" rid="ref10">10</xref>
                </sup>
            </p>
            <p>Counselling can involve a variety of methods. With the help of a fourth-generation framework, the multi-theory model predicts changes in health behaviour over time.
                <sup>
                    <xref ref-type="bibr" rid="ref11">11</xref>
                </sup>
                <sup>,</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref12">12</xref>
                </sup> Because of the lack of moderators, the model&#x2019;s fluidity allows the constructs to be modified to a wide range of behaviours. MTM is unique among health behaviour models in that it allows practitioners to decide the most successful strategy for encouraging patients to start and maintain healthy habits without needing to consult several models. In the MTM the health behaviour change is separated into initiation and maintenance or continuity of the health behaviour change.
                <sup>
                    <xref ref-type="bibr" rid="ref13">13</xref>
                </sup>
                <sup>&#x2013;</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref16">16</xref>
                </sup>
            </p>
            <p>The Transtheoretical Model can help you understand how individuals and populations develop toward adopting and maintaining healthy habits (TTM). The transtheoretical model combines elements of psychotherapy and behaviour modification philosophies. During the five stages of the model (precontemplation, contemplation, preparation, action, and maintenance), behaviour changes can be observed. To be most productive, intervention of a health care contributor should coincide with the patient&#x2019;s stage of change. Ten cognitive and behavioural processes are involved in the model that shows how change takes place when a person is moving among the stages. Change is described in terms of the coping mechanisms utilised by the processes (social liberation, dramatic relief, assisting connections, conscious experience, environmental re-evaluation, reinforcement management, self-re-evaluation, sensory stimulation, counterconditioning, and independence). When intervening, the pharmacist must first ask questions regarding the patient&#x2019;s behaviour in order to determine the stage of the disease. Those in the contemplation stage are inclined to learn more about smoking and its impacts on their wellbeing, but those in the planning phase are ready to set objectives and make decisions regarding quitting methods. Smokers who are in the executing phase are trying to quit smoking.
                <sup>
                    <xref ref-type="bibr" rid="ref17">17</xref>
                </sup>
                <sup>,</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref18">18</xref>
                </sup>
            </p>
            <p>Modified MTM is a health behaviour theory that predicts one-time and long-term health behaviour modification using a fourth-generation framework. The model&#x2019;s flow allows the components to be changed to varied changes in health behaviour. This model represents the modified version of multi theory model due to the various lacunae being assessed by the researchers such as the self-reporting analysis as the crucial method for collection of data. False reporting, dishonesty, poor evaluation, subjectivity, and other factors can all lead to bias in self-reports. Researchers who use this method must additionally use more objective techniques to supplement their measurements. Hence this modified method will record their self-reflection diary and co-relate with their third person (i.e., relative) record diary facilitating the social support to assess the false reporting of the participant. This will also provide the instrument of measurement of cotinine levels pre intervention, during the intervention and post intervention. The modified version will provide motivational interviewing along with participatory dialogue for enhancing the willingness to quit. Using this unified framework method, find the most effective technique to motivate their patients to start and maintain healthy habits. The protocol will aid in conduct of research to assess and compare the efficacy of Multi theory Model and Modified Multi theory model as against Transtheoretical model as assessed by Nicotine Dependence, Stages of Change Scale, Smoking abstinence and urine cotinine level on smoking cessation at Community Level.</p>
        </sec>
        <sec id="sec2" sec-type="methods">
            <title>Methods</title>
            <sec id="sec3">
                <title>Protocol amendments</title>
                <p>If the trial protocol is to be changed after approval, the same people who signed the trial protocol must sign a written amendment. Any changes to the protocol will indeed take effect once they&#x2019;ve been accepted by the IEC as well as the appropriate authorities. Any significant protocol modification impacting the benefit-to-risk ratio will be disclosed to the appropriate IEC. Any significant modifications to the experiment will be communicated to participants, and they will be required to reaffirm their consent in writing (
                    <xref ref-type="fig" rid="f1">Figure 1</xref>).</p>
                <fig fig-type="figure" id="f1" orientation="portrait" position="float">
                    <label>Figure 1. </label>
                    <caption>
                        <title>Implementation: Random allocation Sequence (10).</title>
                    </caption>
                    <graphic id="gr1" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/147116/3937aae8-8ad5-40b1-98ce-38dbeea218a8_figure1.gif"/>
                </fig>
            </sec>
            <sec id="sec4">
                <title>Methodology</title>
                <p>The research will be carried out in a primary health care facility. Two separate intervention groups were used in this investigation. The study design is three arm parallel cluster randomized interventional trial and cluster sampling method has been selected. The sample size has been calculated to 240 i.e., 80 in each group.</p>
                <p>
                    <bold>Group I:</bold> 80 patients Multi theory Model for smoking cessation</p>
                <p>
                    <bold>Group II:</bold> 80 patients Transtheoretical Model for smoking cessation</p>
                <p>
                    <bold>Group III: </bold>80 patients Modified Multi theory Model for smoking cessation</p>
                <p>The groups were same in terms of gender, age of peer group, marital status, education level, time period i.e., years of smoking, and level of nicotine addiction.</p>
            </sec>
            <sec id="sec5">
                <title>Eligibility criteria of participants</title>
                <p>
                    <bold>Inclusion criteria:</bold>
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>Patients willing to quit smoking after motivation</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>Patients, males with age group 18-44-year-old.</p>
                        </list-item>
                        <list-item>
                            <label>3.</label>
                            <p>Patients with years of smoking &gt;5 years.</p>
                        </list-item>
                        <list-item>
                            <label>4.</label>
                            <p>Patients with Nicotine dependence &#x2265;5.</p>
                        </list-item>
                        <list-item>
                            <label>5.</label>
                            <p>Patients with Education level more than 7 years and Socioeconomic level according to Modified Kuppuswamy scale more &#x2265;5</p>
                        </list-item>
                    </list>
                </p>
                <p>
                    <bold>Exclusion criteria:</bold>
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>Patients not ready to quit after motivation</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>Immunocompromised Medical conditions</p>
                        </list-item>
                        <list-item>
                            <label>3.</label>
                            <p>Self-reported severe mental illness that may impede group treatment (i.e., bipolar disorder, schizophrenia)</p>
                        </list-item>
                        <list-item>
                            <label>4.</label>
                            <p>Those who are already receiving treatment for cessation of smoking</p>
                        </list-item>
                        <list-item>
                            <label>5.</label>
                            <p>Behaviours that were not appropriate for a group intervention (e.g., intoxication).</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec6">
                <title>Study setting</title>
                <p>Study will be conducted in primary health centre of the university for conducting community-based projects.</p>
            </sec>
            <sec id="sec7">
                <title>Outcome measure</title>
                <p>All the outcome measures will be assessed before and after the intervention.</p>
                <p>
                    <bold>Fagerstrom Test for Nicotine Dependence</bold>: The Fagerstrom Test for Nicotine Dependence was developed by Karl O. Fagerstrom in 1989 with the purpose of measuring the level of physical dependence on cigarettes. In our nation, Uysal 
                    <italic toggle="yes">et al.</italic> (2004) examined the dependability and factor analysis of the Turkish version.
                    <sup>
                        <xref ref-type="bibr" rid="ref19">19</xref>
                    </sup>
                    <sup>&#x2013;</sup>
                    <sup>
                        <xref ref-type="bibr" rid="ref22">22</xref>
                    </sup>
                </p>
                <p>
                    <bold>Self-Abstinence Scale:</bold> The SASEQ appeared to be a short, reliable, and valid questionnaire to assess self-efficacy beliefs regarding smoking abstinence. This instrument also had good predictive validity.</p>
                <p>
                    <bold>Urine Cotinine Level:</bold> The urine cotinine levels will be assessed pre and post intervention. In humans, cytochrome P450 2A6 processes cotinine, one of the major metabolites of nicotine, a key component of tobacco smoke (CYP2A6). Cotinine is excreted as an N-glucuronide conjugation in the urine, accounting for 10&#x2013;15 percent of total nicotine excreted undamaged plus other metabolites; it can also be found in blood, urine, saliva, hair, and nails.
                    <sup>
                        <xref ref-type="bibr" rid="ref23">23</xref>
                    </sup>
                </p>
                <p>
                    <underline>
                        <bold>Sample size estimation</bold>
                    </underline>
                </p>
                <p>
                    <bold>Sample size is determined with the help of formula given below,</bold>
                    <disp-formula id="e1">
                        <mml:math display="block">
                            <mml:mi mathvariant="normal">N</mml:mi>
                            <mml:mo>=</mml:mo>
                            <mml:mn>4</mml:mn>
                            <mml:mspace width="0.25em"/>
                            <mml:mfenced close=")" open="(">
                                <mml:mrow>
                                    <mml:mi>DE</mml:mi>
                                    <mml:mo>/</mml:mo>
                                    <mml:mi mathvariant="normal">n</mml:mi>
                                </mml:mrow>
                            </mml:mfenced>
                            <mml:mspace width="0.25em"/>
                            <mml:mo>&#x00d7;</mml:mo>
                            <mml:mspace width="0.25em"/>
                            <mml:msup>
                                <mml:mrow>
                                    <mml:mo stretchy="true">(</mml:mo>
                                    <mml:msub>
                                        <mml:mi mathvariant="normal">Z</mml:mi>
                                        <mml:mrow>
                                            <mml:mn>1</mml:mn>
                                            <mml:mo>&#x2212;</mml:mo>
                                            <mml:mi mathvariant="normal">y</mml:mi>
                                        </mml:mrow>
                                    </mml:msub>
                                    <mml:mo>+</mml:mo>
                                    <mml:msub>
                                        <mml:mi mathvariant="normal">Z</mml:mi>
                                        <mml:mrow>
                                            <mml:mn>1</mml:mn>
                                            <mml:mo>&#x2212;</mml:mo>
                                            <mml:mi mathvariant="normal">&#x03b1;</mml:mi>
                                            <mml:mo>/</mml:mo>
                                            <mml:mn>2</mml:mn>
                                        </mml:mrow>
                                    </mml:msub>
                                    <mml:mo stretchy="true">)</mml:mo>
                                </mml:mrow>
                                <mml:mn>2</mml:mn>
                            </mml:msup>
                            <mml:mspace width="0.25em"/>
                            <mml:mo>&#x00d7;</mml:mo>
                            <mml:mspace width="0.25em"/>
                            <mml:msup>
                                <mml:mfenced close=")" open="(">
                                    <mml:mrow>
                                        <mml:mn>1</mml:mn>
                                        <mml:mo>/</mml:mo>
                                        <mml:mi mathvariant="normal">d</mml:mi>
                                    </mml:mrow>
                                </mml:mfenced>
                                <mml:mn>2</mml:mn>
                            </mml:msup>
                        </mml:math>
                    </disp-formula>
                </p>
                <p>Level of significance (&#x03b1;) = 0.05</p>
                <p>N = No. of clusters</p>
                <p>Z
                    <sub>1-y</sub> = Percentile of the standard normal distribution (e.g., 1.28 for a power of 90%)</p>
                <p>Z (
                    <sub>1-&#x03b1;/2)</sub> = 1.96</p>
                <p>n = 
                    <bold>&#x221a;</bold> (1-p)c/ps, cluster size = 2 per group</p>
                <p>DE = Design Effect</p>
                <p>Z alpha value = 1.96</p>
                <p>Z y value = 0.80</p>
                <p>Sample size = N = 80 per group</p>
                <p>Total Sample size = 240</p>
            </sec>
            <sec id="sec8">
                <title>Allocation and concealment mechanism</title>
                <p>In all three arms, patients will be randomised using block randomization. The personnel at the main health centre will create the allotment sequence, registered candidates, and allocate people to interventions. Participant Identification Form, Fagerstrom Test for Nicotine Dependence, Smoking Abstinence Scale, and urine cotinine level will be used to collect data. In- person interviews will be held by the investigator for assessing the data. Pre-test data were collected when the researcher gave all of the data collecting instruments to the participants in the first month (at the first visit), a few days before the sessions. In the third month, after the initial meeting, the members were provided the &#x201c;Stages of Change Scale&#x201d; via face-to-face interviews with the investigator (second visit). Results of the first interim test have been acquired, and the second training will be given. Following the second training, the researcher administered the &#x201c;Stages of Change Scale&#x201d; through face-to-face interviews to collect the second interim test results, and the third training will be delivered. Following the completion of the trainings, post-test data was obtained by handling all data collecting instruments, including the Fagerstrom Test for Nicotine Dependence, the Smoking Abstinence Scale, and urine cotinine level. The investigator included 16 questions on the subject identification questionnaire, which was created in compliance with the appropriate literature.
                    <sup>
                        <xref ref-type="bibr" rid="ref24">24</xref>
                    </sup>
                </p>
            </sec>
            <sec id="sec9">
                <title>Statistical analysis</title>
                <p>The statistical significance level is considered at p &lt; 0.05. The statistical programme will be SPSS (Statistical Package for Social Sciences) Version 20.1 (IBM Corporation, Chicago, USA). The Cronbach&#x2019;s alpha test was used to analyse the questionnaire&#x2019;s and tool&#x2019;s reliability and validity. The baseline measurements taken before the intervention will be compared to the measurements taken one month, three months, and six months later. There will be descriptive and analytical statistics. The information will be provided in terms of mean and standard deviation.</p>
                <p>The Shapiro-Wilk test will be used to determine whether the data is normal. Parametric testing (One-way Anova test and Repeated measure Anova for test assessment at 1st, 3rd, and 6th month between all outcome measures.) will be used if the data follows a normal distribution, and non-parametric tests (Kruskal Wallis test and Friedman test) will be used if the data does not have a normal distribution.</p>
            </sec>
            <sec id="sec10">
                <title>Variables of the study</title>
                <p>
                    <list list-type="bullet">
                        <list-item>
                            <label>&#x2022;</label>
                            <p>The Transtheoretical models, Multi Theory Model, and Modified Multi Theory Model were used as independent variables in the study.</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Dependent variables for the three groups were Smoking Abstinence, level of nicotine dependence, and Urine cotinine level.</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Age, gender, marital status, degree of education, years of smoking, and nicotine dependency were all used as control factors in the study.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
        </sec>
        <sec id="sec11" sec-type="discussion">
            <title>Discussion</title>
            <p>Transtheoretical Model is the standard health model used for Smoking cessation behavioural methods. The transtheoretical model in which the applied research was conducted was assessed by Jo P and Velicer WF. Improvements in recruiting, persistence, and development have been demonstrated utilizing phase therapies and active selection procedure. Consistent patterns have been observed across 12 different health behaviours, among the benefits and costs of change, as well as the many changes process. Across 12 health habits, consistent connections between the benefits and drawbacks of altering and the stages of change were established. Computer-based personalised and interactive interventions have yielded the most promising data outcomes.
                <sup>
                    <xref ref-type="bibr" rid="ref25">25</xref>
                </sup> A study conducted by Bakan AB and Erci B examined the transtheoretical and health belief models with 96 volunteer nurses. Using a validated questionnaire method, the impact of both models on smoking cessation was assessed. The health belief model group&#x2019;s negative opinions toward smoking were much greater than the Trans theoretical Model groups. The transtheoretical model approach has shown more positive effect in behavior change.
                <sup>
                    <xref ref-type="bibr" rid="ref26">26</xref>
                </sup>
            </p>
            <p>A 38-item, face and content validated, MTM-based survey questionnaire was provided to the participants in a study conducted by Nahar VK 
                <italic toggle="yes">et al.</italic> Participatory discussion and behavioural confidence were both important indicators of smoking cessation behaviour intention. Emotional transformation was a significant predictor of intention for sustenance for smoking cessation behaviour.
                <sup>
                    <xref ref-type="bibr" rid="ref27">27</xref>
                </sup>
            </p>
            <p>MTM predicts health behaviour change across cultures by claiming that health behaviour change happens in two stages: initiation and maintenance. Several other health behaviour improvements have been validated using this paradigm. The best probable determinants of smoking cessation start and persistence within cigarette smokers were discovered using multiple regressions. The purpose of this research is to see how well MTM can describe tobacco cessation and protracted maintenance in smokers.
                <sup>
                    <xref ref-type="bibr" rid="ref28">28</xref>
                </sup>
            </p>
            <p>Carolyn J Heckma 
                <italic toggle="yes">et al.</italic>, determined the efficiency of motivational interviewing for smoking cessation by a comprehensive review and meta-analysis The data imply that current MI smoking cessation methods could help adolescents and adults quit smoking. The superiority of MI over control therapies did not decrease over time in studies with more than one follow-up time point. The effects of MI differed between trials, and it was difficult to pinpoint intervention or research factors that contributed to impact size heterogeneity. This superiority of Motivational Interviewing has been factor should be compared with other approaches for its better effectiveness. The combination of Motivational Interviewing with MTM can significantly improve the chances of smoking cessation among the smokers i.e., modified multi theory model.
                <sup>
                    <xref ref-type="bibr" rid="ref29">29</xref>
                </sup>
            </p>
            <p>Nicola Lindon Hawley (2015) A systematic evaluation found 28 studies published between 1997 and 2014 with over 16,000 participants. MI was done in a series of one-six sessions, each lasting about 10 and 60 minutes. Motivational questioning seems to be fairly fruitful in helping people quit smoking in comparison to standard care or brief recommendations. Studies that assessed more intense versus less intensive motivational interviewing as part of their study design indicated that less intensive support was linked to higher abstinence rates.
                <sup>
                    <xref ref-type="bibr" rid="ref30">30</xref>
                </sup> Gholamreza Heydari, 
                <italic toggle="yes">et al.</italic> 2014, performed a literature search which was done from 2000 to 2012 to gather information on the pharmacological and behavioral interventions on smoking cessations. The inter-rater reliability was 67% before discussion for a better analysis. All the article for behavioral interventions has proven a better quit rate with positive effect. Less studies were conducted on such methods and more approaches in combination are encouraged. All the studies promote the evaluation of various behavioral techniques for identifying the current evidence and latest outcomes.
                <sup>
                    <xref ref-type="bibr" rid="ref30">30</xref>
                </sup>
            </p>
            <sec id="sec12">
                <title>Ethical aspects</title>
                <p>The proposed study&#x2019;s protocol was reviewed and approved by the IEC i.e. institutional Ethical Committee. After receiving approval, the study was registered as a randomised controlled trial. The study will be explained to the participants, as well as the intervention that will be used. They will be requested to sign a permission form in the local language before the research begins. The trial information will be treated in compliance with the Data Protection Law.
                    <sup>
                        <xref ref-type="bibr" rid="ref31">31</xref>
                    </sup> Under the Data Monitoring Committee (DMC), a group of four members of the IEC will be constituted to ensure the trial&#x2019;s ethical conducted. If the trial is terminated, the IEC and the Competent Regulatory Authorities will be notified.</p>
            </sec>
            <sec id="sec13">
                <title>Data management/handling with missing data</title>
                <p>The validity and consistency of data entries are checked automatically online. A responsible investigator must either rectify the questionable facts or establish its legitimacy and provide an adequate explanation. If the data is not rectified, it will be highlighted, allowing for a quick review of all suspect entries. All flagged data will be checked by a responsible monitor, who will create questions that will be submitted back to the appropriate investigator. All &#x201c;inconsistencies&#x201d; will be resolved by the investigator. After the study is completed, additional tests for plausibility, consistency, and completeness of data will be undertaken.</p>
                <p>All missing values or abnormalities will be reported to the locations, and a qualified researcher will investigate and resolve them. In time-to-event analysis, for participants with inadequate follow-up, the period to the last follow-up date will be used as the censoring period. Insufficient data for continuous outcomes over time will be addressed using a multifaceted approach that assumes data is missing at random, eliminating the need for direct imputation. The sustainability of this hypothesis will be examined utilizing pattern combining models in sensitivity testing, provided that data does not go missing at random. Otherwise, there will be no imputation of missing data. It is necessary to establish and substantiate the cause for the withdrawal. For individuals with inadequate follow-up, the period to last follow-up date is used as the limiting period in time-to-event data analysis</p>
            </sec>
            <sec id="sec14">
                <title>Auditing the data</title>
                <p>The researchers voluntarily give the auditors/inspectors/monitors easy accessibility to the trial records for examination, with the understanding that this staff is bound by professional secrecy. The researcher would make every attempt to assist with the auditing and examinations, providing access to all essential facilities, records, and paperwork over time.</p>
            </sec>
        </sec>
        <sec id="sec15" sec-type="conclusion">
            <title>Conclusion</title>
            <p>National Tobacco control program implemented in India have been merged with various other governing bodies for reducing the consumption and supply of tobacco. The efforts have been undermined due to lack of utilization of tobacco cessation cell services placed at an institutional setting and costly pharmacotherapy management. Implementation of Behavioral Change Methods i.e., the Multi theory Model and Modified Multi theory Model can help the community in improving their health status by advancing smoking cessation approaches at primary health centers and a resource scarce setting. On overcoming the limitations of transtheoretical model by conducting theory-comparison and multiple-behavior research can prove to be a better approach for smoking cessation to the community. New methods of behaviour modification, such as the Modified Multi Theory Model, will be used to improve recruitment and retention, particularly among diverse populations; improve treatment fidelity; develop common metrics across behaviours that can be used to advance the measurement and assessment of smoking cessation; and expand the reach of effective intervention approaches through translation.</p>
            <p>
                <bold>Implication:</bold> This study helps towards long term smoking cessation among the smokers by the application of Transtheoretical model, Multi theory Model and Modified Multi theory Model.</p>
            <p>
                <bold>Study status:</bold> selection of participants for each group.</p>
        </sec>
    </body>
    <back>
        <sec id="sec18" sec-type="data-availability">
            <title>Data availability</title>
            <p>No data is associated with this article.</p>
        </sec>
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