mHealth Messaging to Motivate Quitline Use Quitting

NCT03567993 | Completed Results DMC

• 2 other identifiers: H00012953R01TW010647
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Use Cessation

Keywords

mhealth; Tobacco cessation; Vietnam; Smoking cessation

Outcome Measures

Primary Outcomes (1)

• Participant Tobacco Cessation Rate (Quit Rate) at 6 Months

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

  At 6 months post-randomization

Secondary Outcomes (1)

• Change in Self-efficacy Scores Using the Self Efficacy Questionnaire (SEQ-12)

  From randomization to 6 months post-randomization

Study Arms (2)

Comparison

ACTIVE COMPARATOR

The comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group.

Behavioral: Comparison

Intervention

EXPERIMENTAL

The intervention is designed to encourage and remind smokers of the availability of the Quitline services. In addition to the one-way motivational messages, the investigators will use two-way assessments. Two-way automated texting is the ability to push out a question, have the user respond with a brief, numeric or one-word answer, and based on that answer, provide immediate feedback. The goal of these brief assessments is two-fold: 1) to assess behavior (abstinence) and motivation to use services, and 2) to return feedback tailored to each individual smoker based on the answers of the user.

Behavioral: Intervention

Interventions

Comparison BEHAVIORAL

Participants randomized to the comparison arm will receive twice-monthly abstinence assessments from the text messaging system, with no motivational feedback. Those in the comparison arm are neither offered nor encouraged to participate in the intervention.

Comparison

Intervention BEHAVIORAL

Participants randomized to the intervention arm will receive: 1. Motivational Messages 2. Abstinence and Motivation to Use Services Assessments 3. Encouragement to access the Quitline 4. Encouragement to use Nicotine Replacement Therapy (NRT) 5. Provision of NRT, if requested Intervention subjects are encouraged to access the Quitline and use NRT. However, these are not mandatory components of the intervention and subjects can choose if they would like to engage with the Quitline or use NRT.

Also known as: mHealth Intervention

Intervention

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age.
• Resident of a selected commune.
• Be a current smoker.
• Be able to receive texts and read text (literate).
• Not be cognitively impaired (as assessed by study staff).
• Not have helped develop messages used in the intervention.
• Not be a family member of another participant in the study.

You may not qualify if:

• \<18 years of age.
• Cognitively impaired (as assessed by study staff).
• Pregnant.
• Prisoner.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Institute of Population, Health and Development, Vietnam: collaborator
• National Institutes of Health (NIH): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Institute of Population, Health, and Development (PHAD)

Hanoi, Vietnam

Location

Related Publications (1)

• Larkin C, Wijesundara J, Nguyen HL, Ha DA, Vuong A, Nguyen CK, Amante D, Ngo CQ, Phan PT, Pham QTL, Nguyen BN, Nguyen ATP, Nguyen PTT, Person S, Allison JJ, Houston TK, Sadasivam R. mHealth Messaging to Motivate Quitline Use and Quitting: Protocol for a Community-Based Randomized Controlled Trial in Rural Vietnam. JMIR Res Protoc. 2021 Oct 7;10(10):e30947. doi: 10.2196/30947.

  PMID: 34617915 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation; Smoking Cessation

Interventions

Methods

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Rajani Sadasivam
• Organization: UMass Chan Medical School

rajani.sadasivam@umassmed.edu

508-456-8923

Study Officials

• Rajani S Sadasivam, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Population and Quantitative Health Sciences

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 26, 2018
• Study Start: November 23, 2018
• Primary Completion: April 8, 2021
• Study Completion: March 31, 2023
• Last Updated: February 14, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)