RECRUITING

OMEGA - Dietary Intervention - COPD Trial

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Conditions

COPD, Chronic Obstructive Pulmonary Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

OMEGA - Dietary Intervention - COPD Trial

Quick Facts

Study Start:2022-03-01
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05297279

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 40 years,
  2. * Physician diagnosis of COPD,
  3. * 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.
  4. * Tobacco exposure ≥ 10 pack-years,
  5. * 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.
  6. * Low omega-3 intake (reported daily intake of EPA+DHA intake \<500 mg via diet and/or supplement) at the screening visit, and
  7. * Willing to comply with dietary recommendations
  1. * Participant planning to change residence during study period,
  2. * Other chronic lung disease, except those with history of asthma if it felt by the investigator not to be a primary diagnosis.
  3. * Pregnancy or breastfeeding and
  4. * Reported unwillingness to eat seafood.

Contacts and Locations

Study Contact

Wendy Lorizio, MD, MPH
CONTACT
410-550-2449
wlorizi1@jhmi.edu
Maggie Maly
CONTACT
410-550-9527
mmaly1@jhmi.edu

Principal Investigator

Nadia Hansel, MD, MPH
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Bayview Campus
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Nadia Hansel, MD, MPH, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-01
Study Completion Date2026-09

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

  • COPD, Chronic Obstructive Pulmonary Disease