Pilot Randomised Controlled Trial of ToQuit Intervention in India

Summary

Tobacco use is associated with high mortality, and a range of morbidities including cancer, and lung and cardiovascular diseases. Furthermore, tobacco users who die prematurely deprive their families of income, raise the cost of health care and hinder economic development. India is the second-largest consumer (current use-48% males, 20% females; 275 million adults) and third largest producer of tobacco in the world5; and has one of the highest mortality related to tobacco. The treatment gap for tobacco use in India is as high as 92%. Opportunistic screening and brief interventions in primary care, although recommended by the World Health Organization (WHO), is largely missing in current practice in India.

The existing tobacco cessation strategy in India has shown limited success due to poor availability and accessibility of tobacco cessation services, and non-availability of interventions that are culturally relevant and contextual to the target population.

Preliminary formative research as a part of the larger ToQuit study has informed the development of the first version of the treatment package. This first version of the package was tested through a case series, by refining the intervention content and delivery mechanisms through an iterative process, to develop the final intervention. This pilot Randomised Control Trial (RCT) will aim to empirically evaluate the feasibility and acceptability of the mobile-based brief intervention (BI) for tobacco use, generate preliminary estimates of the impact of the BI, and fine-tune the procedures for a definitive RCT.

Conditions

• Tobacco Use

Interventions

BEHAVIORAL

ToQuit, a technology delivered tobacco cessation intervention

The intervention messages will consist of specific content areas derived from the formative research of the study. Some of the components of the intervention include * Psychoeducation about consequences of tobacco use and benefits of quitting; * goal setting; * managing goals and self-monitoring of behavior; * avoidance strategies; * self-awareness and reflection messages; * social and pharmacological support, and help-seeking; * identifying and managing cravings; * relapse prevention strategies.

BEHAVIORAL

Tobacco quitting helplines

Participants from the control group will be sent the details of other functional tobacco helplines in India.

Sponsors & Collaborators

• Sangath

  lead OTHER

Principal Investigators

• Abhijit Nadkarni · London School of Hygiene and Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2021-09-18

Completion

2021-09-18

Countries

• India

Study Locations