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Effectiveness of a Multi-component Intervention for Smokeless Tobacco Cessation during Pregnancy

Development & Pilot Testing of a Novel Multi-component Intervention Using Biomarker Feedback and Cognitive-Social Health Information-Processing (C-SHIP) Model Based Intervention for Smokeless Tobacco Cessation during Pregnancy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064075
Enrollment
100
Registered
2024-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: H- Substance Abuse Treatment

Interventions

Intervention1: Developed multi component intervention on the principles of CBT, MET and Brief intervention + 5A intervention: Duration of Intervention:20-30 minutes
Components of intervention: 1. Biomarker (Salivary cotinine levels) feedback Salivary cotinine, a metabolite of nicotine, is a biomarker of overall tobacco use. This study will use salivary cotinine l

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for pregnant females Women with 12 weeks or less than 12 weeks pregnancy Smokeless tobacco uses within last 2 days Visiting in the antenatal clinic Aged 18 or above Communicate in Hindi or English Inclusion criteria for non pregnant females Smokeless tobacco uses within last 2 days Aged 18 or above Communicate in Hindi or English Age, education, and socio-economic status matched with pregnant females

Exclusion criteria

Exclusion criteria: Exclusion criteria for pregnant females Those with unstable medical conditions as advised by the doctor in charge Poor cognitive state Having mental illness Those participating in other tobacco cessation program Exclusion criteria for non pregnant females Those with unstable medical conditions as advised by the doctor in charge Poor cognitive state Having mental illness Those participating in other tobacco cessation program

Design outcomes

Primary

MeasureTime frame
Estimate recruitment and retention rates. 30 days Point prevalence abstinence in late pregnancy (32 weeks) (self-reported tobacco use status will be obtained and will be biochemically verified through use urine cotinine testing) Timepoint: 32 weeks Pregnancy

Secondary

MeasureTime frame
Continued abstinence in late pregnancy (32 weeks) after quitting in early pregnancy (self-reported tobacco use status will be obtained & will be biochemically verified through use of urine cotinine testing). Smokeless tobacco reduction from the first antenatal visit to late pregnancy (32weeks): Any reducing quantity of smokeless tobacco (self-Reported) Timepoint: Baseline, 4 weeks & 32 weeks

Countries

India

Contacts

Public ContactDr Parbhoo Dayal

All India Institute of Medical Sciences, New Delhi

prabhudayal.aiims@gmail.com919312512707

Outcome results

None listed

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