OMEGA - Dietary Intervention - COPD Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change in COPD health status as assessed by the COPD assessment test [Срок оценки: Baseline, months 1 and 2 follow up calls, 3 months and 6 months]
• Change in COPD health status/health-related quality of life as assessed by the Clinical COPD Questionnaire health-related quality of life questionnaire [Срок оценки: Baseline, months 1 and 2 follow up calls, 3 months and 6 months]

Вторичные конечные точки (5)

• Change in the number of exacerbation episodes reported due to moderate and/or severe COPD-related exacerbations [Срок оценки: Baseline, months 1 and 2 follow up calls, 3 months and 6 months]
• Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1) [Срок оценки: Baseline, 3 months and 6 months]
• Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1) percent predicted [Срок оценки: Baseline, 3 months and 6 months]
• Change in exercise capacity as assessed by the Six-Minute Walk Distance [Срок оценки: Baseline, 3 months and 6 months]
• Change in Quality of Life as assessed by the St. George's Respiratory Questionnaire [Срок оценки: Baseline, 3 months and 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Johns Hopkins Bayview Campus — Baltimore

Идентификаторы

NCT: NCT05297279 · IRB00302442 · R01HL158615

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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