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Mobile Health Technology for Personalized Tobacco Cessation Support in Laos

Study acronym: SupportLaos
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 15, 2025 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Re-verified, no change to tracked fieldsv6
  2. Notable Primary and study completion dates: Aug 31, 2025 to Aug 31, 2026
    • Interventions: Nicotine patch (Drug), Self-help materials (to support smoking cessation (Behavioral), Smartphone-based automated treatment for smoking… to Nicotine patch (Drug), Self-help materials (to support smoking cessation) (Behavioral), Smartphone-based automated treatment for smoking…
    v5
  3. Minor Start date: Apr 20, 2022 to Apr 27, 2022v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Notable Trial status: Active, Not Recruiting to Recruiting
    • Start date: Sep 1, 2020 to Apr 20, 2022
    • Site details revised at 2 of 2 sites
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05233228
Lead Sponsor University of Oklahoma
Collaborators: Setthathirath Hospital, Champasak Hospital, Lao PDR, National Center for Laboratory and Epidemiology, Lao PDR, National Tobacco Control Committee, Lao PDR, H. Lee Moffitt Cancer Center and Research Institute
Conditions
(from sponsor)
Cigarette Smoking
Related terms Cigarette Smoking
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov