Mobile Health Technology for Personalized Tobacco Cessation Support in Laos

NCT05233228 | Recruiting Phase 2

• 1 other identifier: 12189
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

In Lao People's Democratic Republic (Lao PDR), 51% of adult men and 7% of adult women smoke tobacco. The development and evaluation of sustainable tobacco cessation interventions suitable for widespread adoption in nations such as Lao PDR are pressing public health needs. To address this need, the investigators propose a project that adapts a theoretically and empirically based mobile health (mHealth) technology to help people quit smoking cigarettes in Lao PDR. This mHealth approach includes a fully automated, interactive, personalized, smartphone-delivered intervention for behavioral treatment, delivered through our Insight™ platform. This proposed project for Lao PDR includes 2 main phases. In the R21 Phase, the investigators will use formative research methods to adapt our intervention content to the sociocultural context, language, and communication styles of Laotians. In the subsequent R33 Phase, the investigators will conduct a randomized controlled trial (RCT) to evaluate the efficacy of our mHealth intervention and technology. Adult smokers of both sexes will be recruited through 2 large hospitals: Setthathirath Hospital in Vientiane and Champasak Hospital in Champasak Province. Participants (n=500) will be randomized to 1 of 2 treatment groups: Standard Care (SC; n=250) or Automated Treatment (AT; n=250). SC consists of brief advice to quit smoking delivered by research staff, self-help written materials, and a 2-week supply of NRT (transdermal patches). AT consists of all SC components plus a fully automated smartphone-based treatment program that involves interactive and personalized proactive messages, images, or videos. The primary health outcome of the trial is biochemically confirmed self-reported 7-day point prevalence abstinence 12 months post study enrollment. The project also aims to advance mHealth research capacity in Lao PDR and sustain the US-Lao PDR research network. The project has the potential to transform healthcare services for tobacco cessation treatment throughout the country and, ultimately, to reduce tobacco-induced morbidity and mortality significantly.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (2)

• Smoking status at 12 months post-enrollment (R33 Phase)

  The primary outcome is smoking status at 12 months post-enrollment. Abstinence will be defined as biochemically confirmed self-reported 7-day point prevalence abstinence with expired CO \<6 ppm.

  12 months post enrollment

• Smoking status at 3 months post-enrollment (Pilot RCT, R21 Phase)

  The primary outcome is smoking status at 3 months post-enrollment. Abstinence will be defined as biochemically confirmed self-reported 7-day point prevalence abstinence with expired CO \<6 ppm.

  3 months post enrollment

Secondary Outcomes (1)

• Number of cigarettes smoked per day

  In-clinic assessments at months 3 and 12

Study Arms (2)

Automated Treatment

EXPERIMENTAL

Consists of all SC components plus a fully automated smartphone-based treatment program that involves interactive and personalized proactive messages, images, or videos.

Drug: Nicotine patch; Behavioral: Self-help materials (to support smoking cessation); Behavioral: Smartphone-based automated treatment for smoking cessation

Standard Care

ACTIVE COMPARATOR

Consists of brief advice to quit smoking delivered by research staff, self-help written materials, and a 2-week supply of nicotine replacement therapy (transdermal patches).

Drug: Nicotine patch; Behavioral: Self-help materials (to support smoking cessation)

Interventions

Nicotine patch DRUG

Provision of nicotine replacement medications in the form of transdermal patches is important to address nicotine withdrawal/craving for smokers who want to quit. Evidence supporting the safety and efficacy of NRT is vast. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care. Therefore, we will provide NRT to all participants in both groups in the early cessation phase.

Automated Treatment; Standard Care

Self-help materials (to support smoking cessation) BEHAVIORAL

The self-help materials were developed by NTCC in Lao, based on the World Health Organization's "A guide for tobacco users to quit".

Automated Treatment; Standard Care

Smartphone-based automated treatment for smoking cessation BEHAVIORAL

The automated treatment(AT) include text messages, images, and videos. The AT content is designed to tap the theoretical mechanisms described in the Phase-Based Model (PBM). That is, treatment content is designed to increase motivation, self-efficacy, use of coping skills, and social support, while reducing nicotine withdrawal symptoms and stress. The AT will begin immediately after enrollment and continue for a 26-week period. The AT approach allows for several levels of personalization for each participant, including tailoring to participants' specific health conditions, individual cessation phases, and participants' self-efficacy level or smoking status in the past week.

Automated Treatment

Eligibility Criteria

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

You may qualify if:

• aged ≥18 years
• self-reported current combustible cigarette smokers (smoked at least 100 cigarettes in lifetime and currently smoke ≥1 cigarette/day)
• willing to set a quit date within 2 weeks of study enrollment
• able to provide written informed consent to participate
• able to read Lao (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form).

You may not qualify if:

• history of a medical condition that precludes use of NRT
• ineligibility to participate based on medical or psychiatric conditions diagnosed by a physician/clinician
• enrollment in another cessation program or current use of other cessation medications.

Sponsors & Collaborators

• University of Oklahoma: lead
• Setthathirath Hospital: collaborator
• Champasak Hospital, Lao PDR: collaborator
• National Center for Laboratory and Epidemiology, Lao PDR: collaborator
• National Tobacco Control Committee, Lao PDR: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (2)

Champasak Hospital

Champasak, Laos

RECRUITING

Setthathirath Hospital

Vientiane, Laos

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Shweta Kulkarni, MS

  Stephenson Cancer Center, TSET Health Promotion Research Center of OUHSC

  STUDY DIRECTOR

Central Study Contacts

Thanh C Bui, MD, DrPH

CONTACT

+1-713-474-6040; thanh-c-bui@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 10, 2022
• Study Start: April 27, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After RCT data collection is complete.
• Access Criteria: After an institutionally approved data sharing agreement is established, deidentified IPD will be shared via a secure data transfer mechanism approved by OUHSC. Data sharing requests will be reviewed and approved by the PI and OUHSC.

Locations

LA (2)