The INTERvening for LUNG Health Trial

Conditions

• Spirometry

Eligibility Criteria

Sex

ALL

Age

9 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Community health worker-delivered multi-component respiratory health intervention — BEHAVIORAL
  Participants receive a community health worker-delivered, multi-component intervention designed to reduce environmental and infectious respiratory risk factors and promote healthy behaviors over 40 months. Components include tobacco cessation counseling for participants who use tobacco; use of N95/KN95 masks during periods of high ambient air pollution; use of surgical masks and handwashing during household respiratory illness or viral seasons; provision and use of a HEPA air purifier with filter replacement and a HEPA-filter vacuum cleaner; promotion of regular physical activity through goal setting and self-monitoring; facilitation of annual influenza vaccination for household members; and pneumococcal conjugate vaccination (PCV20) for eligible participants. Intervention activities are reinforced through regular home visits by trained community health volunteers.

Study Details

This research study is being done to find out whether a community health volunteer-delivered, multi-component program can improve lung health for people at risk of chronic respiratory diseases (such as asthma or COPD) in Bhaktapur, Nepal. The program focuses on reducing tobacco smoke exposure, reducing indoor and outdoor air pollution exposure, preventing respiratory infections (including vaccination and mask use during viral seasons), and encouraging safe physical activity. The "index participant" is the main enrolled participant in the household who is randomized to the intervention or control arm. The participant will be in the study for about 40 months and will have 11 research visits: one at baseline and then every 4 months through month 40. At visits, staff will do breathing tests (spirometry before and after an inhaled medicine), measure exhaled carbon monoxide, check blood pressure, measure height/weight at selected visits, and ask questions about symptoms, smoking, infections, vaccines, and quality of life. The participant will also wear an activity monitor (accelerometer) for 2 weeks at baseline and at follow-up visits. If individual is a household member (not the index participant), the participant may be asked to complete baseline and follow-up assessments every 4 months through month 40, will receive the influenza vaccine and will primarily be asked to use masks and handwashing during household respiratory illness episodes (only if the index participant is randomized to the intervention) and will not be asked to wear an activity monitor. If the participant is in the pilot phase, participation will last about 2 months. the participant will complete baseline procedures and pilot follow-up visits during those 2 months instead of the full 40-month schedule.

Key Dates

Start date

Jul 1, 2026

Status verified

Jun 2026

Primary completion

Apr 1, 2030

Completion

Jul 1, 2030

Study Design

Enrollment

800 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• No Intervention: Usual care (control) arm
  Participants randomized to the usual care (control) arm will continue routine healthcare and daily practices and will not receive the study intervention during the 40-month follow-up period. Control participants will complete the same schedule of research assessments as the intervention arm, including spirometry, questionnaires, accelerometry, and other study measurements conducted at baseline and every four months. The participant will not receive community health worker visits, vaccines facilitated through the study, air purifiers, vacuum cleaners, masks, or behavioral counseling during the trial. At the conclusion of the study, control households will receive educational materials and will be offered an air purifier and vacuum cleaner.
• Experimental: Intervention
  Participants randomized to the intervention arm will receive a community health worker-delivered, multi-component intervention designed to reduce environmental and infectious respiratory risk factors and promote healthy behaviors over a 40-month follow-up period. Components include tobacco cessation counseling for participants who use tobacco; use of N95/KN95 masks during periods of high ambient air pollution; use of surgical masks and handwashing during household respiratory illness or viral seasons; provision and use of a HEPA air purifier with periodic filter replacement and a HEPA-filter vacuum cleaner; promotion of regular physical activity through goal setting and self-monitoring; facilitation of annual influenza vaccination for household members; and pneumococcal conjugate vaccination (PCV20) for eligible participants. These components are reinforced through regular home visits by trained community health volunteers.

Primary Outcome Measure

Pre-bronchodilator FEV₁ Z-score at 40 months [ Time Frame: 40 months ]

Central Contacts

• William Checkley, MD, PhD
  +1 443-287-4587
  [email protected]
• Erika Miller, MHS
  +1 443-287-4235
  [email protected]

Locations (1)

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