OMEGA - Dietary Intervention - COPD Trial
Who can join
Ages 40 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Age ≥ 40 years, * Physician diagnosis of COPD, * Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume in the First Second (FEV1)/ Forced Vital Capacity (FVC) \<70% and FEV1 (% predicted) \<80%. IF FEV1/FVC \<70% and FEV1 (% predicted) ≥ 80%, additional requirement will be asked: CAT score ≥ 10. Also, IF available for screening purposes: participant can provide a previous pulmonary function testing (PFT) report within the last 6 months. * Tobacco exposure ≥ 10 pack-years, * Poverty criteria as determined by residing in a neighborhood with ≥10% of residents living in poverty, consistent with the definition of poverty area OR not access to private health insurance, OR only completed high school education or less. * Low omega-3 intake (reported daily intake of EPA+DHA intake \<500 mg via diet and/or supplement) at the screening visit, and * Willing to comply with dietary recommendations Exclusion Criteria: * Participant planning to change residence during study period, * Other chronic lung disease, except those with history of asthma if it felt by the investigator not to be a primary diagnosis. * Pregnancy or breastfeeding and * Reported unwillingness to eat seafood.
About the study
A randomized controlled trial of a food delivery dietary intervention targeting increased omega-3 intake to determine whether dietary modifications can improve Chronic Obstructive Pulmonary Disease (COPD) outcomes and attenuate the adverse effects of particulate matter on respiratory health.
Investigators believe that study results will comprehensively address the impact of an evidence-based nutrition intervention on COPD health and provide a framework for dietary intervention within other chronic diseases disproportionately impacting susceptible, low-income populations.
What is being tested
- Home delivery Omega-3 rich Food (behavioral)
- Dietary Motivational Coaching (behavioral)
- Home delivery Food (behavioral)
Sponsor: Johns Hopkins University · Participants: 200 · Started: Mar 1, 2022
Contact the study team
- Wendy Lorizio, MD, MPH · Phone: 410-550-2449
- Maggie Maly · Phone: 410-550-9527
Official record on ClinicalTrials.gov — NCT05297279
Locations in the U.S.
| Maryland | Johns Hopkins Bayview Campus, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.