Clinical trial NCT05297279: OMEGA - Dietary Intervention - COPD Trial
Official title: OMEGA - Dietary Intervention - COPD Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD, Chronic Obstructive Pulmonary Disease
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-03-28
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in COPD health status as assessed by the COPD assessment test
timeFrame: Baseline, months 1 and 2 follow up calls, 3 months and 6 months
measure: Change in COPD health status/health-related quality of life as assessed by the Clinical COPD Questionnaire health-related quality of life questionnaire
timeFrame: Baseline, months 1 and 2 follow up calls, 3 months and 6 months
Secondary outcomes:
measure: Change in the number of exacerbation episodes reported due to moderate and/or severe COPD-related exacerbations
timeFrame: Baseline, months 1 and 2 follow up calls, 3 months and 6 months
measure: Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1)
timeFrame: Baseline, 3 months and 6 months
measure: Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1) percent predicted
timeFrame: Baseline, 3 months and 6 months
measure: Change in exercise capacity as assessed by the Six-Minute Walk Distance
timeFrame: Baseline, 3 months and 6 months
measure: Change in Quality of Life as assessed by the St. George's Respiratory Questionnaire
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Nadia Hansel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: