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NCT05297279 | RECRUITING | COPD, Chronic Obstructive Pulmonary Disease

OMEGA - Dietary Intervention - COPD Trial
Sponsor:

Johns Hopkins University

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.

Condition or disease

COPD, Chronic Obstructive Pulmonary Disease

Intervention/treatment

Home delivery Omega-3 rich Food

Dietary Motivational Coaching

Home delivery Food

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : DOUBLE
Primary Purpose : OTHER
Official Title : OMEGA - Dietary Intervention - COPD Trial
Actual Study Start Date : 2022-03-01
Estimated Primary Completion Date : 2027-03
Estimated Study Completion Date : 2027-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
OMEGA - Dietary Intervention - COPD Trial

Location Details

NCT05297279

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Locations

RECRUITING

United States, Maryland

Johns Hopkins Bayview Campus

Baltimore, Maryland, United States, 21224