NCT05758272

Brief Summary

This study aims to test, by a 2-arm RCT, the effectiveness of an intervention that includes mobile phone-supported simple physical exercise for smoking cessation in workplaces in Hong Kong.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
646

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

February 23, 2023

Last Update Submit

December 6, 2023

Conditions

Keywords

smokersWorkplaceExercisemhealthintervention

Outcome Measures

Primary Outcomes (1)

  • Self-reported 7-day point-prevalence abstinence (PPA) at 6-months follow-up

    Self-reported abstinence in the past 7 days at 6-months after treatment initiation

    at 6-month after treatment initiation (3 months after the end of treatment)

Study Arms (2)

mobile phone-based simple physical exercise intervention

EXPERIMENTAL

Regular messages supporting participants in practicing simple physical exercises and assist in managing cravings will be sent to participants via IM apps and scheduled in a tapering manner for 3 months (twice per week in the first month to once per week in the third month). Images and videos explaining and demonstrating the simple physical exercises will be sent to the participants via IM apps, which serves as a reminder and supporting materials for participants. The benefits of exercise in SC will be explained. The investigators will also encourage the practice of moderate/ vigorous exercises to further improve the physical activity and well-being of the participants. Various delivery formats of messages will be considered to attract participants' interest such as text, emojis, voice, image, animation, and video. The simple exercises consist of a) Zero-time exercises (ZTEx), b) handgrip exercises and c) resistance exercises.

Behavioral: mobile phone-based simple physical exercise reminder to help quit smoking

regular text-based intervention

PLACEBO COMPARATOR

The control group will receive 6 regular messages via IM at twice per month within 3 months. These messages cover simple cessation advice and reminders for telephone follow-ups.

Behavioral: regular text-based intervention

Interventions

Regular messages supporting participants in practicing simple physical exercises and assist in managing cravings will be sent to participants via IM apps and scheduled in a tapering manner for 3 months (twice per week in the first month to once per week in the third month). Images and videos explaining and demonstrating the simple physical exercises will be sent to the participants via IM apps, which serves as a reminder and supporting materials for participants. The benefits of exercise in SC will be explained. The investigator will also encourage the practice of moderate/ vigorous exercises to further improve the physical activity and well-being of the participants. Various delivery formats of messages will be considered to attract participants' interest such as text, emojis, voice, image, animation, and video. The simple exercises consist of a) Zero-time exercises (ZTEx), b) handgrip exercises and c) resistance exercises.

mobile phone-based simple physical exercise intervention

The control group will receive 6 regular messages via IM at twice per month within 3 months. These messages cover simple cessation advice and reminders for telephone follow-ups.

regular text-based intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hong Kong residents aged 18 or above
  • Smoke at least 1 cigarette per day or use other tobacco products (EC, HTP and others) daily
  • Able to communicate in Cantonese/Mandarin and read Chinese
  • Able to use instant messaging tools (e.g. WhatsApp) for communication
  • Stay in Hong Kong during the intervention and follow-up periods (12 months)

You may not qualify if:

  • Smokers who are psychologically or physically unable to communicate
  • Currently joining other smoking cessation program(s)
  • Smokers who cannot tolerate the proposed exercise program
  • Smokers who have severe mental illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Man Ping WANG, PhD

    School of Nursing, The University of Hong Kong Hong Kong, Hong Kong China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 7, 2023

Study Start

January 1, 2023

Primary Completion

June 30, 2024

Study Completion

December 30, 2024

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Participant data (IPD) will only be used for data analysis by the investigators, kept strictly confidential, and not disclosed to anyone outside the research group.

Locations