Mobile Health Technology for Personalized Tobacco Cessation Support in Laos
ConditionCigarette Smoking
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Nicotine patch
DrugProvision 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.
Self-help materials (to support smoking cessation)
BehavioralThe self-help materials were developed by NTCC in Lao, based on the World Health Organization's "A guide for tobacco users to quit".
Smartphone-based automated treatment for smoking cessation
BehavioralThe 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Automated TreatmentExperimental treatment 3 interventions
Group B: Standard CareActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months post enrollment2
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.
Time frame
3 months post enrollmentSecondary outcomes
1
Number of cigarettes smoked per day
At the final follow-up (month 3 for the pilot trial and month 12 for the R33 Phase), participants will be asked to self-report their average current numbers of cigarettes smoked per day
Time frame
In-clinic assessments at months 3 and 12Sponsors and contacts
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University of Oklahoma
Lead sponsor
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
Source ClinicalTrials.gov