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Randomized Control Study to Study the Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals Who Want to Quit Tobacco Use
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.
There is a high prevalence of tobacco use in the community that continue to remain underserved in terms of intervention and support for their tobacco use. Yoga is a culturally acceptable practice that can reduce craving and help people quit tobacco. However, we didn't come across Indian studies looking at yoga to reduce craving in individuals who use 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. Aim: To study the feasibility of yoga in reducing craving in individuals who use tobacco Objectives: Primary * To evaluate the feasibility of yoga based intervention on craving in tobacco dependent individuals who want to quit tobacco use Secondary/tertiary * To assess the effect on abstinence * To assess quit rate Sampling frame: Screened positive participants will be recruited from Rural community health and training centre, Mugalur, Tobacco cessation centre and OPDs of Department of general medicine, pulmonary medicine, cardiology, oncology, ENT and dental surgery and other super speciality OPD at SJMCH . Sample recruitment/sampling method: Participants who fulfilled the inclusion criteria will be approached by the principal investigator and/or junior research fellow, and those who agreed to participate in the study will be randomly allocated to one of two groups via simple randomization. Randomisation will be computerised. This will be done in blocks of 10. Outcome assessor will be blinded to the randomisation. Principal investigator will not be involved in randomization of participants. Training/ interventions/assessments/ procedures in the study -Participants in yoga arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser. Procedure: Screening positive participants fulfilling eligibility criteria, information regarding study is given and informed consent is documented. Selection of a quit date within 21 weeks. Standard of living index(SLI) or Modified Kuppuswamy Scale for sociodemographic data (10mins), Fagerstrom scale(5 mins), Motivation to stop smoking (1 min) . Participants are randomized into intervention and TAU groups with 48 participants each. For intervention group, sixty minute yoga session will be imparted. The first session shall be offline, the rest of the 6 sessions shall be online.. After Completion all assessments will be done again both of intervention and TAU groups.Follow up at 21 weeks, 1 month and at 3 months. -To assess relapse Hypothesis Yoga will be a feasible method to reduce craving in tobacco dependent individuals who want to quit tobacco use
Age
18 - 65 years
Sex
MALE
Healthy Volunteers
No
St.John's Medical College and Hospital
Bengaluru, Karnataka, India
Start Date
November 1, 2024
Primary Completion Date
May 31, 2026
Completion Date
December 31, 2026
Last Updated
December 2, 2025
96
ESTIMATED participants
Yoga
BEHAVIORAL
WHO 5As model intervention
BEHAVIORAL
Lead Sponsor
University of Pittsburgh
Collaborators
NCT06543407
NCT06218056
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04832659