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An economic analysis and assessment of a behavioral modification program to help poor pregnant Indian women reduce/ quit the usage of chewing tobacco products.

Economic Evaluation and effectiveness of a multicomponent behavior centered intervention to reduce smokeless tobacco (ST) use among pregnant women of low socio economic status: A Randomized Control Trial in Urban community setting in India - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077900
Enrollment
200
Registered
2024-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: BREATHE (Building Resilience, Empowerment, and Awareness for Smokeless-Tobacco free Healthy Expectancies): The intervention package shall be based on findings of the literature review,

Sponsors

Dr Tanvi Kiran
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Consenting Pregnant women (18 years and above) who belong to low socio- economic status (as assessed by Kuppuswamy scale) attending the ANC registration clinics/public health facilities located in urban settlements of Burail and sector 25D of Chandigarh. 2) Those among the above reporting current smokeless tobacco use (categorised as having low to moderate risk scores) as classified by tobacco use screening component of WHO ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) 3) Those pregnant women who are in their first four months of ANC registration.

Exclusion criteria

Exclusion criteria: 1) Pregnant women of low socio- economic status reporting the current use of any other drug of abuse besides tobacco shall be excluded from the study. 2) Non-co-operative participants who though after giving consent do not cooperate in providing time for participating in the intervention. 3) Any other criteria identified by the experts.

Design outcomes

Primary

MeasureTime frame
1) Development of a multicomponent behaviour cantered intervention (IEC material, booklets, dedicated informational video etc) to reduce the smokeless tobacco use among pregnant women of low socio-economic status 2) Percentage of current and past smokeless tobacco usage by use among pregnant women of low socio economic status in urban community setting of Chandigarh 3) Percentage of smokeless tobacco users with previous quit attempts made and availed cessation services 4) Nicotine dependence smokeless tobacco scores as measured by Fagerstrom test (ST) for nicotine dependence 5) Tobacco use abstinence/reduction by the current smokeless tobacco user (quit attempt) for at least one day 6) Stage of behaviour change in the smokeless tobacco user (Precontemplation, Contemplation, Preparation, Action and Maintenance) 7) Incremental Cost-effectiveness ratiosTimepoint: 1) Baseline 2) Immediately after intervention 3) 3 months after intervention 4) 6 months after intervention

Secondary

MeasureTime frame
1. Any reported diverse maternal outcomes (Preterm birth, Intrauterine growth restriction, alike) 2. Any reported adverse neonatal outcomesTimepoint: 1) Immediately after intervention 2) 3 months after intervention 3) 6 months after intervention

Countries

India

Contacts

Public ContactDr Tanvi Kiran

Postgraduate Institute of Medical Education and Research

kiran.tanvi@pgimer.edu.in9876867850

Outcome results

None listed

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