OMEGA - Dietary Intervention - COPD Trial

NCT05297279 | Recruiting DMC

• 2 other identifiers: IRB00302442R01HL158615
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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)

  Baseline, 3 months and 6 months

• Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1) percent predicted

  Baseline, 3 months and 6 months

• Change in exercise capacity as assessed by the Six-Minute Walk Distance

  Baseline, 3 months and 6 months

• Change in Quality of Life as assessed by the St. George's Respiratory Questionnaire

  Baseline, 3 months and 6 months

Study Arms (2)

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.

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.

Behavioral: Home delivery Food

Interventions

Home delivery Omega-3 rich Food BEHAVIORAL

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.

Active/Intervention Treatment Arm

Dietary Motivational Coaching BEHAVIORAL

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.

Active/Intervention Treatment Arm

Home delivery Food BEHAVIORAL

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.

Control Treatment Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Campus

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nadia Hansel, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Lorizio, MD, MPH

CONTACT

410-550-2449; wlorizi1@jhmi.edu

Maggie Maly

CONTACT

410-550-9527; mmaly1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 28, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)