Ignite Creation Date:
2024-07-17 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488443
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-18
Brief Title:
Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Randomized Control Study to Study the Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals Who Want to Quit Tobacco Use
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 didnt 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 Secondarytertiary
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 recruitmentsampling method
Participants who fulfilled the inclusion criteria will be approached by the principal investigator andor 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 interventionsassessments 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 indexSLI or Modified Kuppuswamy Scale for sociodemographic data 10mins Fagerstrom scale5 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 groupsFollow 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
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 Secondarytertiary
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 recruitmentsampling method
Participants who fulfilled the inclusion criteria will be approached by the principal investigator andor 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 interventionsassessments 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 indexSLI or Modified Kuppuswamy Scale for sociodemographic data 10mins Fagerstrom scale5 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 groupsFollow 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D43TW009114 | NIH | None | None |