OMEGA - Dietary Intervention - COPD Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
Johns Hopkins Bayview Campus
RECRUITING
Baltimore
Contact Information
Primary
Wendy Lorizio, MD, MPH
wlorizi1@jhmi.edu
410-550-2449
Backup
Maggie Maly
mmaly1@jhmi.edu
410-550-9527
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 200
Treatments
Active_comparator: Active/Intervention Treatment Arm
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.
Placebo_comparator: Control Treatment Arm
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.
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov