OMEGA - Dietary Intervention - COPD Trial

Johns Hopkins University

Status: Enrolling

Conditions: COPD, Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: Home delivery Omega-3 rich Food; Behavioral: Home delivery Food; Behavioral: Dietary Motivational Coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05297279

IRB00302442

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Active/Intervention Treatment Arm

Active Comparator group

Description:

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.

Treatment:

Behavioral: Dietary Motivational Coaching

Behavioral: Home delivery Omega-3 rich Food

Control Treatment Arm

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Home delivery Food