NCT06488443

Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals

Randomized Control Study to Study the Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals Who Want to Quit Tobacco Use

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
BEHAVIORAL	Yoga	Participants in yoga arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser.All the yoga exercises selected for this study are low-impact and involve highly controlled movements. All yoga exercises will be taught and supervised by a skilled yoga-instructor. The yoga-instructor will take great care to emphasize to participants that they should not go beyond their usual range of motion/comfort for any of the yoga exercises.
BEHAVIORAL	WHO 5As model intervention	WHO 5As model to help patients ready to quit. The five major steps to intervention are the "5 A's": Ask, Advise, Assess, Assist, and Arrange.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-05-31
• Completion: 2026-12-31
• First posted: 2024-07-05
• Last updated: 2025-12-02

Locations

1 site across 1 country: India