OMEGA - Dietary Intervention - COPD Trial
Johns Hopkins University
200 participants
Mar 1, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria4
- 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.
Interventions
The active treatment arm will receive voucher (with a specified amount) weekly home delivery omega-3 rich food for the 12-weeks (3 months) intervention. Participants will be limited to purchasing foods rich in omega-3 only.
The active treatment arm will receive weekly personalize dietary couching by a dietary coach on omega-3 rich food for the 12-weeks intervention. Participant will also receive educational materials and guidance about what kind of food to order, how to cook, prepare (recipes) and store omega-3 rich foods.
The control treatment arm will receive voucher (with a specified amount) weekly home delivery food (any kind of food) for the 12-weeks (3 months) intervention. Participant will not receive dietary coaching on food choices and will not be limited to purchasing foods rich in omega-3.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05297279