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临床试验/CTRI/2024/07/071710
CTRI/2024/07/071710尚未招募2 期

Comparing the effectiveness of behavioral counselling using role modelling technique and video based tobacco cessation counselling among the adults of Paliyar Tribes-A Randomized Controlled Trial

Dr Mariya Shiney J.E1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年8月25日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
Effectiveness of behavior counselling using role modelling technique and video based tobacco cessation counselling among Paliyar tribes

研究概览

简要总结

AIMTo assess and compare the effectiveness of behavior counselling using role modelling technique and video based tobacco cessation counselling among Paliyar tribes

RESEARCH QUESTION Is there a difference in the effectiveness of role model based behavior counselling and video based tobacco cessation counselling among the adults of Paliyar Tribes after 6 months

STUDY POPULATION Tribal Population in Sirumalai hills

SAMPLING PROCEDURE The subjects will be selected based on convenience sampling method The subjects will be randomly allocated into test group and control group based on simple random sampling The subjects will be selected based on inclusion and exclusion criteria

STUDY GROUPS The number of groups is 2  Specify the groups Test group Role Model based behavioral counselling Control group-Video based behavior counselling

SAMPLE SIZE Sample size is calculated using G POWER software version 3.1

A sample size of 68 will be collected based on 90 % power and 5 % alpha error

METHODOLOGY/PROCEDURESAt baseline demographic characters and tobacco dependence will be analyzed by Fagerstrom Nicotine dependency scale

INTERVENTIONS FOR TEST GROUP AND CONTROL GROUPFor test group Role model-based behavior counselling technique on tobacco cessation will be given. A community leader/socially responsible person will be identified from the community based on their reading and writing skills will be selected as role model.  The Role model will be trained on behavior counselling technique on tobacco cessation by the investigator. The Role model will be asked to counsel the study subjects on tobacco cessation .During every week the study subjects will be called and interviewed by the investigator. Daily follow up sessions will be done by the role model selected. For control group video based tobacco cessation counselling will be given. The study subjects will receive 4 videos. The video will be of 15 to 20 min of duration.  In the video harmful effects of tobacco use, types of tobacco will be delivered, How the study subjects will deal with difficult situations and attitudes toward smoking and quitting, how to cope with negative moods with coping plans and how to deal with difficult risk situations .Every week phone interviewing will be done by the investigator.  Interviewing will be conducted in the participants language of choice. Daily follow-up sessions will be done by the role model selected.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Study subjects who are 18 or older were included Study subjects who are motivated to quit smokeless tobacco within the next 3 months Study subjects who are able to read and write Study subjects who have access to mobile phones Study subjects who have access to internet.

排除标准

  • Study subjects who are not willing to participate Study subjects who are consuming alcohol Study subjects who are unable to provide informed consent or receive counselling because of impaired mental status cognitive impairment or communicating barrier Study subjects if they had participated in other smoking cessation programs or services.

结局指标

主要结局

Effectiveness of behavior counselling using role modelling technique and video based tobacco cessation counselling among Paliyar tribes

时间窗: 6 months

次要结局

  • Effectiveness of behavior counselling using role modelling technique among Paliyar tribes
  • Effectiveness of video based tobacco cessation counselling among Paliyar tribes(1st month 3rd month 6th month)
  • Effectiveness of behavioral counselling using role modelling technique and video based tobacco cessation counselling among Paliyar tribes(1st month 3rd month 6th month)
  • Assess the tobacco dependence among Palliyar tribes(1st month 3rd month 6th month)

研究者

发起方
Dr Mariya Shiney J.E
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Mariya Shiney JE

Indira Gandhi Institute of Dental Sciences

研究点 (1)

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