NCT03567993: M2Q2

mHealth Messaging to Motivate Quitline Use Quitting

Completed NA Results posted Last updated 14 February 2024

What this trial tests

NA trial testing Comparison in Tobacco Use Cessation in 750 participants. Completed in 31 March 2023.

Timeline

23 November 2018

Primary endpoint
8 April 2021

31 March 2023

Quick facts

Lead sponsor	University of Massachusetts, Worcester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	750
Start date	23 November 2018
Primary completion	8 April 2021
Estimated completion	31 March 2023
Sites	1 location across Vietnam

Drugs / interventions tested

• Comparison
• Intervention

Conditions studied

• Tobacco Use Cessation — all drugs for Tobacco Use Cessation →

Sponsor

University of Massachusetts, Worcester

Who can join

18 and older, any sex, with Tobacco Use Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participant Tobacco Cessation Rate (Quit Rate) at 6 Months Primary · At 6 months post-randomization

7 day point prevalence cessation per self-report with additional carbon monoxide monitor verification for those who report cessation.

Group	Value	95% CI
Comparison	.50
Intervention	.52

Change in Self-efficacy Scores Using the Self Efficacy Questionnaire (SEQ-12) Secondary · From randomization to 6 months post-randomization

Study team will administer the Self Efficacy Questionnaire (SEQ-12), an 12-item questionnaire to measure self-reported confidence of current and former smokers in their ability to abstain from smoking in high-risk situations (e.g., when facing internal stimuli (e.g., feeling depressed) and external stimuli (e.g., being with smokers)). The SEQ-12 consists of 12 items; each item is rated on a 5-point Likert scale (1=not at all sure, 2=not very sure, 3=more or less sure, 4=fairly sure, and 5=absolutely sure). SEQ-12 scores range from 12 to 60, with higher scores indicating greater self-efficacy.

Group	Value	95% CI
Comparison	43	± 10.2
Intervention	43	± 10.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected through study completion, an average of 6 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Comparison

Serious: 1/378 (0%)

Deaths: 1/378

Intervention

Serious: 1/372 (0%)

Deaths: 1/372

Serious adverse events (2 terms)

Reaction	System	Comparison	Intervention
Death	Respiratory, thoracic and mediastinal disorders	—	—
Death	Cardiac disorders	—	—

Most-reported serious reactions: Death, Death.

Data from ClinicalTrials.gov NCT03567993 adverse events section.

Sponsor's own description

The mHealth Messaging to Motivate Quitline Use and Quitting, or "M2Q2" study, is a collaborative research project for a mobile health intervention designed to motivate smoking cessation and encourage access to counseling. The study is for men and women smokers in Vietnam's Red River Delta region who are 18 years of age or older.

The primary hypothesis is that smokers in the M2Q2 intervention will have higher rates of smoking cessation, compared with the comparison group.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. mHealth Messaging to Motivate Quitline Use and Quitting: Protocol for a Community-Based Randomized Controlled Trial in Rural Vietnam.
   Larkin C, Wijesundara J, Nguyen HL, Ha DA, et al · · 2021 · cited 3× · PMID 34617915 · DOI 10.2196/30947