Brief Advice and Breathing EXercises (BABEX) for quitting tobacco use in low income communities in India

Cluster randomized trial of a brief tobacco cessation intervention for low income communities in India

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23362894

Enrollment

850

Registered

2012-06-07

Start date

2012-07-30

Completion date

Unknown

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco users Mental and Behavioural Disorders Mental and behavioural disorders due to use of tobacco

Interventions

Intervention arm: 1. Obtain informed consent 2. Complete questionnaire by interview and offer the intervention. 3. Provide brief advice based on a script with personalized modifications 4. Provide tra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults, aged 23+ years of age ( the age limit is necessary to avoid contamination with a previous research study with participants up to 21 years) 2. Current self reported tobacco users of any tobacco containing product and providing consent for the study

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
1. Self reported abstinence from tobacco use in the 6 months preceding the follow up 2. Salivary cotinine concentration of less than 20ng/ml at that point using a Enzyme-linked immunosorbent (ELISA) assay Measured at 7 months	—

Secondary

Measure	Time frame
1. One week self reported point prevalence abstinence from tobacco use at one month follow up 2. Attempts to stop tobacco use between the intervention and the 1 month follow up 3. One week point prevalence abstinence at the follow up at 7 months confirmed by saliva cotinine assessment	—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026