Using a General Health Promotion Approach to Help Smokers With Chronic Diseases Quit

NCT04037696 | Unknown DMC

• 1 other identifier: NTWCREC19001-Main
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of a general health promotion (GHP) approach to motivate smokers with chronic diseases to quit smoking. Subjects in the intervention group will receive a brief Motivational Interviewing (MI) using a GHP approach. Subjects in the control group will receive a self-help booklet on smoking cessation at the time of recruitment.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Biochemically validated smoking abstinence at 6 months

  The biochemically validated smoking abstinence will be confirmed by a saliva cotinine level of less than 115 ng/ml in parallel test and a carbon monoxide level in expired air of less than 9 parts per million (ppm)

  6-month follow-up

Secondary Outcomes (5)

• biochemically validated smoking abstinence at 12 months

  12-month follow-up

• Self-reported 7-day point prevalence of smoking abstinence at 6 and 12 months

  6- and 12-month follow-up

• Behavioural change

  3-, 6- and 12-month follow-ups

• Smoking quit attempt change from baseline

  3-, 6- and 12-month follow-ups

• Smoking reduction rate change from baseline

  3-, 6- and 12-month follow-ups

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will receive individual face-to-face brief MI (about 5 minutes) on a health-related lifestyle practice. The experimental group will then receive a brief MI via WhatsApp/WeChat on a smartphone during the study period. The brief MI messages will be delivered more intensively as preferred by the subject (usually not less than once every 2 to 3 days and no more than 2 times per day) for the first 6 months. The frequency of delivering the messages via WhatsApp/WeChat will be interactive, depending on the subjects' actions and responses, and may take several sessions of chats within several days or weeks. After 6 months, minimal messages will be provided to the subjects by merely following their progress of behavioural changes and responding to their questions to maintain contact until the 1-year follow-up.

Behavioral: General Health Promotion Approach

Control group

OTHER

The control group will be given general brief advice and receive a self-help booklet on smoking cessation published by the Hong Kong Council on Smoking and Health with Hotline will be also provided in the SOPCs. The subjects in this group will receive the same schedule of follow-ups as in the intervention group, but they will not receive any follow-up booster intervention.

Behavioral: Control

Interventions

General Health Promotion Approach BEHAVIORAL

The trained Research assistants will ask the subjects about the priority of engaging in any desirable health-related lifestyle practice as identified in the completed baseline questionnaires and to state a targeted goal that they perceive as the easiest to achieve. Each subject will then receive an individual face-to-face brief MI (about 5 mins) with generic health advice on selected health-related lifestyle practice. They will then be informed to receive an individual brief MI intervention to assist behavioural changes or achieve goals as desired or chosen by them via WeChat or WhatsApp in smart phones throughout the study period. The RA will then deliver brief MI to each subject individually via WeChat or WhatsApp in smart phones throughout the study period. Readiness of quitting smoking will be assessed at 3-month follow-up. Upon request by subjects, we shall provide them with more comprehensive information on quitting.

Experimental group

Control BEHAVIORAL

The subjects will be given general brief advice and a self-help smoking cessation booklet with Hotline (Tel.: 1833183). However, subjects in the control group will not receive brief MI and follow-up booster intervention.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or above,
• able to speak Cantonese and read Chinese
• no intention to quit smoking (pre-contemplation stage), but are willing to take action to promote health
• have a smart phone and able to use instant messaging tool (e.g. WhatsApp, WeChat) for communication, and
• willing to receive health promotion advices via WhatsApp/WeChat in the smart phone throughout the study

You may not qualify if:

• unable to give informed consent or participate in our intervention due to impaired mental status, cognitive impairment, or communication barrier, and
• participation in other smoking cessation programmes or services

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Ho Cheung William Li, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho Cheung William Li, PhD

CONTACT

+85239176634; william3@hku.hk

Long Kwan Ho, MPhil

CONTACT

+85239176643; longkwan@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: July 30, 2019
• Primary Completion: December 26, 2020
• Study Completion: December 26, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)