COPD, Chronic Obstructive Pulmonary DiseaseNCT05297279
OMEGA - Dietary Intervention - COPD Trial
A study testing Home delivery Omega-3 rich Food, Dietary Motivational Coaching and Home delivery Food in people with COPD, Chronic Obstructive Pulmonary Disease, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Home delivery Omega-3 rich Food, Dietary Motivational Coaching and Home delivery Food
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Bayview Campus
Baltimore, Maryland, 21224
Maggie Maly, 410-550-9527, mmaly1@jhmi.edu
Nadia Hansel, MD, MPH
About this 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.
Read the detailed description
COPD is a leading cause of death in the US with low-income individuals experiencing increased prevalence and morbidity. Poor dietary intake is also prevalent in low-income communities and has been associated with adverse outcomes in populations with respiratory disease. Data generated from the investigators Johns Hopkins NIH/EPA funded Environmental Health Disparities Center was instrumental in showing that poor dietary patterns, and in particular low omega-3 polyunsaturated fatty acid intake, are prevalent in a low income population with COPD. Low omega-3 intake was associated with poor respiratory outcomes and exacerbated the adverse effects of indoor air pollution exposure on respiratory symptoms. Accordingly, diet likely represents an important modifiable risk factor in low income individuals with COPD.
Investigators proposed a 12-week (3 months) randomized controlled intervention trial of a home food delivery dietary intervention targeting increased omega-3 intake to determine whether dietary modifications can improve COPD outcomes and attenuate the adverse effects of particulate matter (PM) on respiratory health. Willing participants with low omega-3 intake assessed during the screening visit will have 1:1 randomization to one of the treatment arms. Outcomes will be assessed monthly and dietary intake will be assessed at 3 months. After the 12-week (3 months) intervention, participants will be followed for an additional 3 months to assess sustainability of the intervention. Participants will be part of this study for 6 months.
The proposed research represents new lines of investigation to test a dietary intervention aimed at: (1) improving respiratory health, and (2) protecting against adverse effects of environmental exposures in low-income adults with COPD.
Investigators will also explore barriers and facilitators of the intervention in order to optimize the sustainability of future implementation strategies.
- Being tested
- Home delivery Omega-3 rich Food, Dietary Motivational Coaching, Home delivery Food
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home delivery Omega-3 rich FoodBehavioural
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.
Dietary Motivational CoachingBehavioural
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.
Home delivery FoodBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active/Intervention Treatment Arm | Active comparator | Participants will receive weekly food voucher (with a specified amount) for home delivery of omega-3 rich food (with a minimum of 4 grams of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in the weekly food order) and personalized dietary coaching. Participant will also receive a single 1-hour one-on-one session (dietary motivational coaching) by a dietary coach to guide participants to consume at least 500 mg of EPA+DHA daily at the beginning of the study, followed by weekly 30-minute calls during the 12-week intervention study period. Receives: Behavioral: Home delivery Omega-3 rich Food; Behavioral: Dietary Motivational Coaching |
| Control Treatment Arm | Placebo comparator | Participants will receive a voucher of weekly food voucher (with a specified amount) for home delivery. Participants in the control arm will also receive a single one-on-one session by a trained research staff member at the beginning of the study, which will be followed by weekly 30-minute calls with the participant during the 12-week intervention study period. The trained research staff member will assist with the online ordering of foods and will provide calls centered on general publicly available, guideline-based dietary recommendations without tailoring or personalization (no dietary coaching). This group will not receive guidance specifically about omega-3 fatty acids. Receives: Behavioral: Home delivery Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COPD health status as assessed by the COPD assessment test
COPD health status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control.
Measured: Baseline, months 1 and 2 follow up calls, 3 months and 6 months
Change in COPD health status/health-related quality of life as assessed by the Clinical COPD Questionnaire health-related quality of life questionnaire
The Clinical COPD Questionnaire (CCQ) health-related quality of life questionnaire (HRQoL) with good psychometric properties. The CCQ consists of 10 items with an overall score and 3 domains: Symptoms (4 items), Functional state (4 items) and Mental state (2 items). High scores indicate worse quality of life.
Measured: Baseline, months 1 and 2 follow up calls, 3 months and 6 months
Secondary outcomes (5)
Change in the number of exacerbation episodes reported due to moderate and/or severe COPD-related exacerbations
Investigators will collect participant's self-report number of exacerbation episodes due to moderate and/or severe COPD-related exacerbation including need for oral corticosteroids or antibiotics for worsening respiratory symptoms, emergency department (ED) visit or hospitalization.
Measured: Baseline, months 1 and 2 follow up calls, 3 months and 6 months
Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1)
Pulmonary function testing will be assessed as FEV1, that is FEV1 (adjusted for age, height, race and sex) according to the American Thoracic Society (ATS) guidelines.
Measured: Baseline, 3 months and 6 months
Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1) percent predicted
Pulmonary function testing will be assessed as FEV1% predicted.
Measured: Baseline, 3 months and 6 months
Change in exercise capacity as assessed by the Six-Minute Walk Distance
The Six-Minute Walk Distance (6MWD) is a test used as a measure of exercise capacity and functional status of participants.
Measured: Baseline, 3 months and 6 months
Change in Quality of Life as assessed by the St. George's Respiratory Questionnaire
St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more limitations.
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Mar 2022
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD, Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nadia Hansel, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297279
- Sponsor's protocol ID
- IRB00302442
- Other IDs
- R01HL158615
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OMEGA - Dietary Intervention - COPD Trial
- ClinicalTrials.gov ID
- NCT05297279
- Acronym / sponsor ID
- IRB00302442
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
COPD is a leading cause of death in the US with low-income individuals experiencing increased prevalence and morbidity. Poor dietary intake is also prevalent in low-income communities and has been associated with adverse outcomes in populations with respiratory disease. Data generated from the investigators Johns Hopkins NIH/EPA funded Environmental Health Disparities Center was instrumental in showing that poor dietary patterns, and in particular low omega-3 polyunsaturated fatty acid intake, are prevalent in a low income population with COPD. Low omega-3 intake was associated with poor respiratory outcomes and exacerbated the adverse effects of indoor air pollution exposure on respiratory symptoms. Accordingly, diet likely represents an important modifiable risk factor in low income individuals with COPD.
Investigators proposed a 12-week (3 months) randomized controlled intervention trial of a home food delivery dietary intervention targeting increased omega-3 intake to determine whether dietary modifications can improve COPD outcomes and attenuate the adverse effects of particulate matter (PM) on respiratory health. Willing participants with low omega-3 intake assessed during the screening visit will have 1:1 randomization to one of the treatment arms. Outcomes will be assessed monthly and dietary intake will be assessed at 3 months. After the 12-week (3 months) intervention, participants will be followed for an additional 3 months to assess sustainability of the intervention. Participants will be part of this study for 6 months.
The proposed research represents new lines of investigation to test a dietary intervention aimed at: (1) improving respiratory health, and (2) protecting against adverse effects of environmental exposures in low-income adults with COPD.
Investigators will also explore barriers and facilitators of the intervention in order to optimize the sustainability of future implementation strategies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active/Intervention Treatment Arm | Active comparator | Behavioral: Home delivery Omega-3 rich Food, Behavioral: Dietary Motivational CoachingParticipants will receive weekly food voucher (with a specified amount) for home delivery of omega-3 rich food (with a minimum of 4 grams of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in the weekly food order) and personalized dietary coaching. Participant will also receive a single 1-hour one-on-one session (dietary motivational coaching) by a dietary coach to guide participants to consume at least 500 mg of EPA+DHA daily at the beginning of the study, followed by weekly 30-minute calls during the 12-week intervention study period. |
| Control Treatment Arm | Placebo comparator | Behavioral: Home delivery FoodParticipants will receive a voucher of weekly food voucher (with a specified amount) for home delivery. Participants in the control arm will also receive a single one-on-one session by a trained research staff member at the beginning of the study, which will be followed by weekly 30-minute calls with the participant during the 12-week intervention study period. The trained research staff member will assist with the online ordering of foods and will provide calls centered on general publicly available, guideline-based dietary recommendations without tailoring or personalization (no dietary coaching). This group will not receive guidance specifically about omega-3 fatty acids. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home delivery Omega-3 rich FoodThe 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. | Behavioural | Active/Intervention Treatment Arm |
| Dietary Motivational CoachingThe 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. | Behavioural | Active/Intervention Treatment Arm |
| Home delivery FoodThe 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. | Behavioural | Control Treatment Arm |
Primary outcome
Change in COPD health status as assessed by the COPD assessment test
Time frame: Baseline, months 1 and 2 follow up calls, 3 months and 6 months
COPD health status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control.
Change in COPD health status/health-related quality of life as assessed by the Clinical COPD Questionnaire health-related quality of life questionnaire
Time frame: Baseline, months 1 and 2 follow up calls, 3 months and 6 months
The Clinical COPD Questionnaire (CCQ) health-related quality of life questionnaire (HRQoL) with good psychometric properties. The CCQ consists of 10 items with an overall score and 3 domains: Symptoms (4 items), Functional state (4 items) and Mental state (2 items). High scores indicate worse quality of life.
5 secondary outcomes
Change in the number of exacerbation episodes reported due to moderate and/or severe COPD-related exacerbations
Time frame: Baseline, months 1 and 2 follow up calls, 3 months and 6 months
Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1)
Time frame: Baseline, 3 months and 6 months
Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1) percent predicted
Time frame: Baseline, 3 months and 6 months
Change in exercise capacity as assessed by the Six-Minute Walk Distance
Time frame: Baseline, 3 months and 6 months
Change in Quality of Life as assessed by the St. George's Respiratory Questionnaire
Time frame: Baseline, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadia Hansel, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home delivery Omega-3 rich Food, Dietary Motivational Coaching and Home delivery Food in people with COPD, Chronic Obstructive Pulmonary Disease, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Lorizio, MD, MPH (410-550-2449, wlorizi1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in COPD health status as assessed by the COPD assessment test (time frame: Baseline, months 1 and 2 follow up calls, 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.