Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals
NCT Number: NCT06488443
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tobacco Dependence
Interventions: BEHAVIORAL: Yoga|BEHAVIORAL: WHO 5As model intervention
Sponsor: University of Pittsburgh
Collaborators: Fogarty International Center of the National Institute of Health|St.John's Medical College and Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-09-30
Locations: St.John's Medical College and Hospital, Bengaluru, Karnataka, 560029, India

Summary:
Yoga is a culturally acceptable practice that can reduce craving and help people quit tobacco. There is a need to evaluate the feasibility of implementation of a well- designed yoga protocol to address craving in individuals who use tobacco in India.

Primary Outcome Measures: Feasibility of yoga based intervention, To evaluate the feasibility of yoga-based intervention in changing craving of tobacco in comparison to WHO 5As intervention on individuals who want to quit tobacco use with Visual Analogue scale (upto score 3 not useful: scores 4,5,6 neutral; 7,8,9, 10 useful) Minimum score is 0 and maximum score is 10, After one week of intervention|Craving of tobacco after intervention, To evaluate the feasibility of yoga-based intervention in changing craving of tobacco measured by Brief Questionnaire of Smoking Urges in comparison to WHO 5As intervention on individuals who want to quit tobacco use using (Scale is 10 items likert scale and total of all item scores is the score, more the score more is the craving)Minimm score is 0 and maximum is 100., After one week of intervention|Craving of tobacco one month follow up, To evaluate the feasibility of yoga-based intervention in changing craving of tobacco measured by Brief Questionnaire of Smoking Urges in comparison to WHO 5As intervention on individuals who want to quit tobacco use (Scale is 10 items likert scale and total of all item scores is the score, more the score more is the craving) Minimum score is 0 and maximum is 100., 1 month after intervention|Craving of tobacco three months follow up, To evaluate the feasibility of yoga-based intervention in changing craving of tobacco (Scale is 10 items likert scale and total of all item scores is the score, more the score more is the craving)measured by Brief Questionnaire of Smoking Urges in comparison to WHO 5As intervention on individuals who want to quit tobacco use. The minimum score is 0 and maximum score is 100., 3 months after intervention
Secondary Outcome Measures: Relapse rate of tobacco use (Number of participants start using tobacco again), To compare effect of yoga Relapse rate of tobacco use on abstinence with WHO 5As intervention group, After one week of intervention|Relapse rate of tobacco use(One month sustainability) ((Number of participants start using tobacco again), To compare effect of yoga intervention on relapse rate of tobacco use with WHO 5As intervention group, 1 month after intervention|Relapse rate of tobacco use (Three months sustainability)(Number of participants start using tobacco again), To compare effect of yoga intervention on relapse rate of tobacco use with WHO 5As intervention group, 3 months after intervention|Quit rate of tobacco, To compare the change in quit rate after yoga intervention with WHO 5As intervention group, After one week of intervention|Quit rate of tobacco (One month sustainability), To compare the change in quit rate after yoga intervention with WHO 5As intervention group, 1 month after intervention|Quit rate of tobacco (Three month sustainability), To compare the change in quit rate after yoga intervention with WHO 5As intervention group, 3 months after intervention|Relapse rate of smoking, To compare the change in relapse rate after yoga intervention with that of WHO 5As intervention group, After one week of intervention|Relapse rate of smoking (One month sustainability), To compare the change in relapse rate after yoga intervention with that of WHO 5As intervention group, 1 month after intervention|Relapse rate of smoking (Three month sustainability), To compare the change in relapse rate after yoga intervention with that of WHO 5As intervention group, 3 months after intervention