N/A
N=143
Wood Smoke Interventions in Native American Populations
Respiratory; Disorder, Functional, Impaired · Respiratory Infection Other
Bottom Line
View on ClinicalTrials.gov: NCT02240069 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Post-intervention FEV1 — 1.9; 2.1; 2.0 liters — p=0.10
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education (Tx1) (Behavioral); Air Filtration Unit Treatment (Tx2) (Device); Placebo Intervention (Tx3) (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of Montana
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-intervention FEV1 |
1.9; 2.1; 2.0 | 0.10 |
| PRIMARY Post-intervention FVC |
2.4; 2.7; 2.5 | 0.28 |
| PRIMARY Post-intervention FEV1/FVC Ratio |
0.78; 0.79; 0.80 | 0.06 |
| PRIMARY Post-intervention Systolic Blood Pressure |
132; 139; 136 | 0.39 |
| PRIMARY Post-intervention Diastolic Blood Pressure |
75; 78; 76 | 0.65 |
| SECONDARY Post-intervention Indoor Fine Particulate Matter (PM2.5) |
38.8; 30.5; 41.6 | 0.88 |
Summary
A critical need exists for efficient community-based interventions aimed at reduction of environmental exposures relevant to health. Biomass smoke exposures due to residential wood heating are common among rural Native American communities, and such exposures have been associated with respiratory disease in susceptible populations. In many of these communities wood stoves are the most economic and traditionally preferred method of residential heating, but resource scarcity can result in burning of improper wood fuels and corresponding high levels of indoor particulate matter. Community-based participatory research techniques will be used to adapt intervention approaches to meet the cultural context of each participating community. At the community level, investigators will facilitate local development of a tribal agency-led wood bank program ensuring that elderly and/or persons with need have access to dry wood for heating. At the household level, investigators will use a three arm randomized placebo-controlled intervention trial to implement and assess education/outreach on best burn practices (Tx1). The content and delivery strategies of the education intervention will be adapted to each community according to stakeholder input. This educational intervention will be evaluated against an indoor air filtration unit arm (Tx2), as well as a placebo arm (Tx3, sham air filters). Tx3 will be used in comparison with the other two treatment arms to evaluate the penetration and efficacy of the community-level wood bank program. Outcomes will be evaluated with respect to changes in pulmonary function measures and respiratory symptoms and conditions among household elders. The investigators hypothesize that locally-designed education-based interventions at the community and household levels will result in efficacious and sustainable strategies for reducing personal exposures to indoor particulate matter, and lead to respiratory health improvements in elderly Native populations. This study will advance knowledge of cost-effective environmental interventions within two unique Native American communities, and inform sustainable multi-level strategies in similar communities throughout the US to improve respiratory health among at-risk populations.
Eligibility Criteria
Inclusion Criteria
- Tribal member from one of the two study regions
- Age 55 years or older.
- Utilize a wood stove as the primary heating source.
- Capable and willing to record symptom data and wood stove usage data, as well as complete pulmonary function testing (i.e., spirometry).
Exclusion Criteria
Data sourced from ClinicalTrials.gov (NCT02240069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.