Mobile Health Technology for Personalized Tobacco Cessation Support in Laos

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

Interventions

DRUG

Nicotine patch

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.

BEHAVIORAL

Self-help materials (to support smoking cessation)

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

BEHAVIORAL

Smartphone-based automated treatment for smoking cessation

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.

Sponsors & Collaborators

• Setthathirath Hospital

  collaborator OTHER

• Champasak Hospital, Lao PDR

  collaborator UNKNOWN

• National Center for Laboratory and Epidemiology, Lao PDR

  collaborator OTHER

• National Tobacco Control Committee, Lao PDR

  collaborator OTHER

• H. Lee Moffitt Cancer Center and Research Institute

  collaborator OTHER

• University of Oklahoma

  lead OTHER

Principal Investigators

• Shweta Kulkarni, MS · Stephenson Cancer Center, TSET Health Promotion Research Center of OUHSC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-27

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• Laos

Study Locations