Recruiting

OMEGA

Sponsor:

Johns Hopkins University

Code:

NCT05297279

Conditions

COPD, Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Home delivery Omega-3 rich Food

Dietary Motivational Coaching

Home delivery Food

Study Details

Brief 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.

Conditions

COPD, Chronic Obstructive Pulmonary Disease

Study ID

NCT05297279

Start date

Mar 1, 2022

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Active/Intervention Treatment Arm

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.

placebo comparator: Control Treatment Arm

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.

Interventions

Home delivery Omega-3 rich Food

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 Coaching

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 Food

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.

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Wendy Lorizio, MD, MPH

410-550-2449wlorizi1@jhmi.edu

Maggie Maly

410-550-9527mmaly1@jhmi.edu

Locations

Johns Hopkins Bayview Campus

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Maggie Maly

410-550-9527mmaly1@jhmi.edu

Principal Investigator:

Nadia Hansel, MD, MPH

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-16.