Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2022-03-01
2027-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
Home delivery Omega-3 rich Food
The active treatment arm will receive voucher (with a specified amount) weekly home delivery omega-3 rich food for the 12-weeks (3 months) intervention. Participants will be limited to purchasing foods rich in omega-3 only.
Dietary Motivational Coaching
The active treatment arm will receive weekly personalize dietary couching by a dietary coach on omega-3 rich food for the 12-weeks intervention. Participant will also receive educational materials and guidance about what kind of food to order, how to cook, prepare (recipes) and store omega-3 rich foods.
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.
Home delivery Food
The control treatment arm will receive voucher (with a specified amount) weekly home delivery food (any kind of food) for the 12-weeks (3 months) intervention. Participant will not receive dietary coaching on food choices and will not be limited to purchasing foods rich in omega-3.
Interventions
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Home delivery Omega-3 rich Food
The active treatment arm will receive voucher (with a specified amount) weekly home delivery omega-3 rich food for the 12-weeks (3 months) intervention. Participants will be limited to purchasing foods rich in omega-3 only.
Dietary Motivational Coaching
The active treatment arm will receive weekly personalize dietary couching by a dietary coach on omega-3 rich food for the 12-weeks intervention. Participant will also receive educational materials and guidance about what kind of food to order, how to cook, prepare (recipes) and store omega-3 rich foods.
Home delivery Food
The control treatment arm will receive voucher (with a specified amount) weekly home delivery food (any kind of food) for the 12-weeks (3 months) intervention. Participant will not receive dietary coaching on food choices and will not be limited to purchasing foods rich in omega-3.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Nadia Hansel, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Bayview Campus
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00302442
Identifier Type: -
Identifier Source: org_study_id
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