Wood Smoke Interventions in Native American Populations
EldersAIR
Residential Wood Smoke Interventions Improving Health in Native American Populations
2 other identifiers
interventional
149
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2014
CompletedFirst Posted
Study publicly available on registry
September 15, 2014
CompletedStudy Start
First participant enrolled
November 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedResults Posted
Study results publicly available
December 1, 2022
CompletedDecember 1, 2022
November 1, 2022
4.6 years
September 10, 2014
November 2, 2022
November 2, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Post-intervention FEV1
Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1), liters
Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
Post-intervention FVC
Mean of up to two post-intervention measures of forced vital capacity (FVC), liters
Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
Post-intervention FEV1/FVC Ratio
Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1) / forced vital capacity (FVC)
Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
Post-intervention Systolic Blood Pressure
Mean of up to two post-intervention measures of systolic blood pressure, millimeters of mercury (mmHg)
Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
Post-intervention Diastolic Blood Pressure
Mean of up to two post-intervention measures of diastolic blood pressure, millimeters of mercury (mmHg)
Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
Secondary Outcomes (1)
Post-intervention Indoor Fine Particulate Matter (PM2.5)
Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Indoor 48-hour PM2.5 average concentration was measured at two post-intervention visits separated by at least three weeks.
Study Arms (3)
Education (Tx1)
EXPERIMENTALEducation on best burn practices
Air Filtration Unit Treatment (Tx2)
ACTIVE COMPARATORA 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.
Placebo Intervention (Tx3)
SHAM COMPARATORA 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.
Interventions
A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove
A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Montana
Missoula, Montana, 59812, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Curtis Noonan
- Organization
- University of Montana
Study Officials
- PRINCIPAL INVESTIGATOR
Curtis W Noonan, Ph.D.
University of Montana
- PRINCIPAL INVESTIGATOR
Annie Belcourt, Ph.D.
University of Montana
- PRINCIPAL INVESTIGATOR
Tony J Ward, Ph.D.
University of Montana
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Professor
Study Record Dates
First Submitted
September 10, 2014
First Posted
September 15, 2014
Study Start
November 30, 2015
Primary Completion
June 30, 2020
Study Completion
February 28, 2021
Last Updated
December 1, 2022
Results First Posted
December 1, 2022
Record last verified: 2022-11