Your session is about to expire
← Back to Search
Omega-3 Rich Diet + Coaching for COPD
N/A
Recruiting
Led By Nadia Hansel, MD, MPH
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 40 years
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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, months 1 and 2 follow up calls, 3 months and 6 months
Awards & highlights
Study Summary
This trial will study whether delivering food rich in omega-3s can help improve COPD outcomes and reduce the harmful effects of particulate matter on respiratory health.
Who is the study for?
This trial is for adults over 40 with COPD, who have smoked at least the equivalent of 10 pack-years. They should be in moderate to severe stages of COPD and not planning to move during the study. Participants must meet certain poverty criteria or have low omega-3 intake, and can't join if they're pregnant, breastfeeding, or unwilling to eat seafood.Check my eligibility
What is being tested?
The OMEGA trial tests whether a diet high in Omega-3s delivered to your home can improve health outcomes for people with COPD. It also includes motivational coaching on diet. The goal is to see if these changes help reduce respiratory issues caused by air pollution.See study design
What are the potential side effects?
Since this intervention involves dietary changes rather than medication, side effects may include possible food allergies or intolerances related to increased seafood consumption as part of the Omega-3 rich foods being introduced.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Select...
My lung condition is moderate to very severe based on GOLD standards.
Select...
My doctor has diagnosed me with COPD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, months 1 and 2 follow up calls, 3 months and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, months 1 and 2 follow up calls, 3 months and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in COPD health status as assessed by the COPD assessment test
Change in COPD health status/health-related quality of life as assessed by the Clinical COPD Questionnaire health-related quality of life questionnaire
Secondary outcome measures
Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1)
Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1) percent predicted
Change in Quality of Life as assessed by the St. George's Respiratory Questionnaire
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active/Intervention Treatment ArmActive Control2 Interventions
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.
Group II: Control Treatment ArmPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,580 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,657 Total Patients Enrolled
Nadia Hansel, MD, MPHPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
84 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 40 years old or older.My lung function is reduced, but I have a high CAT score.My lung condition is moderate to very severe based on GOLD standards.I can provide a lung function test report from the last 6 months.You live in a neighborhood where at least 10% of residents are in poverty, or you don't have private health insurance, or you have completed high school education or less.I have a chronic lung condition, but asthma is not my main diagnosis.You have smoked the equivalent of 10 packs of cigarettes per year for multiple years.You don't eat enough omega-3 fatty acids from food or supplements.You have said you do not want to eat seafood.My doctor has diagnosed me with COPD.
Research Study Groups:
This trial has the following groups:- Group 1: Active/Intervention Treatment Arm
- Group 2: Control Treatment Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment currently open?
"Affirmative. According to clinicaltrials.gov, enrollment for this medical study is open as of March 25th 2022- the trial was initially posted on March 1st 2022. Up to 200 patients are being accepted at a single location."
Answered by AI
What effects is this research intended to produce?
"This clinical trial's primary outcome is to measure the Change in COPD health status over a Baseline, 1 and 2 month follow up calls, 3 months, and 6 months time frame via the COPD assessment test. Additional endpoints include an alteration in Lung Function through Forced Expiratory Volume in the First Second (FEV1) as stipulated by ATS directives; a change in exacerbation episodes from moderate or severe cases of COPD-related exacerbations such as need for antibiotics or oral steroids, ED visits/hospitalization; plus an amendment in exercise capacity measured with the Six-Minute Walk Distance."
Answered by AI
What is the current enrollment figure for this medical experiment?
"Affirmative. According to clinicaltrials.gov, the initial posting of this study was on March 1st 2022 and it has recently been updated as of March 25th 2022. This medical trial is seeking 200 volunteers at one site."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger