Pilot Randomised Controlled Trial of ToQuit Intervention in India

NCT04782453 | Completed

• 1 other identifier: AN_2018_36
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tobacco use; smoking; smokeless tobacco; brief intervention; mobile messaging; Screening, Brief Intervention and Referral to Treatment

Outcome Measures

Primary Outcomes (1)

• Self-reported abstinence from tobacco in past 7 days preceding the outcome assessment

  After 3 months post-randomisation, all the participants will be asked if they used tobacco at least once in past 7 days.

  At 3 months post-randomisation in all participants regardless of treatment completion.

Secondary Outcomes (2)

• Change in mean ASSIST score, from baseline to 3 months post-randomisation

  At baseline and at 3 months post-randomisation in all participants regardless of treatment completion.

• Self-reported abstinence from tobacco in past 28 days preceding the outcome assessment

  At 3 months post-randomisation in all participants regardless of treatment completion.

Study Arms (2)

ToQuit

EXPERIMENTAL

Participants from the ToQuit intervention arm will receive the messages on their mobile phones for 8 weeks. The messages will be sent for 3-4 days a week.

Behavioral: ToQuit, a technology delivered tobacco cessation intervention

Control

OTHER

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

Behavioral: Tobacco quitting helplines

Interventions

ToQuit, a technology delivered tobacco cessation intervention BEHAVIORAL

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.

ToQuit

Tobacco quitting helplines BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>18 years) current users of tobacco in any form. Current user will be defined as individuals who have used tobacco at least once in the past 28 days.
• Willing to quit tobacco in next 2 months,
• Having a personal mobile phone, and
• Able to read and reply to short message service (SMS) text in English or Hindi

You may not qualify if:

• Participants having a shared/family phone
• Age \<18 years
• Owns a mobile phone, but cannot read and reply to English or Hindi messages

Sponsors & Collaborators

• Sangath: lead

Study Sites (1)

Sangath Goa

Panjim, Goa, 403501, India

Location

MeSH Terms

Conditions

Tobacco Use; Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Abhijit Nadkarni

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI and outcomes assessor will be masked. The screeners will recruit participants into the study, who will then be randomized to one of the two study arms. The data team will assign a masked outcome assessor to collect outcome data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A parallel-arm individual randomized controlled trial, with a nested qualitative study. We will randomize participants in the intervention and control groups with 1:1 allocation ratio.

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 4, 2021
• Study Start: April 1, 2021
• Primary Completion: September 18, 2021
• Study Completion: September 18, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)