NCT05732220

Brief Summary

This pilot trial aims to examine the feasibility, acceptability, and preliminary effectiveness of EMA-based peer counseling for youth smokers.

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
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 18, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

February 5, 2023

Last Update Submit

November 4, 2023

Conditions

Smoking Cessation

Keywords

counsellingecological momentary assessmentyoung smokermobile healthadolescsentquitlineChinese

Outcome Measures

Primary Outcomes (1)

  • Biochemically-validated tobacco abstinence

    Defined as a negative result of the iScreen OFD test for measuring salivary cotinine (with a cut-off of lower than 30ng/mL)

    6 months after randomisation

Secondary Outcomes (6)

  • Self-reported 7-day point-prevalence tobacco abstinence

    3 months after randomisation

  • Self-reported 7-day point-prevalence tobacco abstinence

    6 months after randomisation

  • Self-reported 30-day point-prevalence tobacco abstinence

    3 months after randomisation

  • Self-reported 30-day point-prevalence tobacco abstinence

    6 months after randomisation

  • Smoking reduction by at least 50%

    3 months after randomisation

  • +1 more secondary outcomes

Other Outcomes (2)

  • Recruitment rate

    Through recruitment completion, about 6 months

  • Retention rate

    6 months after randomisation

Study Arms (3)

EMA+ group

EXPERIMENTAL

EMA assessment + EMA-based cessation counselling

Behavioral: EMA assessmentBehavioral: EMA-based cessation counselling

EMA group

ACTIVE COMPARATOR

EMA assessment only + Usual peer counselling

Behavioral: EMA assessmentBehavioral: Usual peer counselling

Control

ACTIVE COMPARATOR

Usual peer counselling

Behavioral: Usual peer counselling

Interventions

EMA assessmentBEHAVIORAL

Subjects will be asked to complete 3 waves of ecological momentary assessment (EMA) about smoking cues and smoking consumption via mobile phone at the first, second and third month after baseline (total 6 weeks)

EMA groupEMA+ group
EMA-based cessation counsellingBEHAVIORAL

Subjects will receive tailored peer counselling based on the participants' EMA responses at 1-month and 3-month telephone follow-ups.

EMA+ group
Usual peer counsellingBEHAVIORAL

Subjects will receive peer counselling through telephone during follow-ups (usual care), in which the counsellor will apply the 5As model and motivational interviewing techniques.

ControlEMA group

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 15 to 25 years
  • Have smoked in the past 30 days
  • Own a smartphone with an mobile instant messaging app installed
  • Can communicate in Chinese

You may not qualify if:

  • Youth smokers who are participating in other smoking cessation studies or program other than the HKU Youth Quitline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HKU Youth Quitline

Hong Kong, Hong Kong

Location

Related Publications (5)

  • Chan SS, Wong DC, Fong DY, Leung AY, Lam DO, Mak YW, Lam TH. The establishment and promotion of the first Youth Quitline in Hong Kong: challenges and opportunities. Eval Health Prof. 2008 Sep;31(3):258-71. doi: 10.1177/0163278708320156. Epub 2008 Jun 19.

    PMID: 18566161BACKGROUND

  • Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.

    PMID: 18509902BACKGROUND

  • Van Zundert RM, Ferguson SG, Shiffman S, Engels R. Dynamic effects of craving and negative affect on adolescent smoking relapse. Health Psychol. 2012 Mar;31(2):226-34. doi: 10.1037/a0025204. Epub 2011 Sep 26.

    PMID: 21942749BACKGROUND

  • McClure EA, Tomko RL, Carpenter MJ, Treiber FA, Gray KM. Acceptability and compliance with a remote monitoring system to track smoking and abstinence among young smokers. Am J Drug Alcohol Abuse. 2018;44(5):561-570. doi: 10.1080/00952990.2018.1467431. Epub 2018 May 8.

    PMID: 29737885BACKGROUND

  • Fanshawe TR, Halliwell W, Lindson N, Aveyard P, Livingstone-Banks J, Hartmann-Boyce J. Tobacco cessation interventions for young people. Cochrane Database Syst Rev. 2017 Nov 17;11(11):CD003289. doi: 10.1002/14651858.CD003289.pub6.

    PMID: 29148565BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Tzu Tsun Luk, PhD, RN

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

February 5, 2023

First Posted

February 16, 2023

Study Start

May 18, 2023

Primary Completion

August 31, 2024

Study Completion

October 31, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)