OMEGA - Dietary Intervention - COPD Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in COPD health status as assessed by the COPD assessment test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Home delivery Omega-3 rich Food (Behavioral)
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.
干预措施: Dietary Motivational Coaching (Behavioral)
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.
干预措施: Home delivery Food (Behavioral)
结局指标
主要结局
Change in COPD health status as assessed by the COPD assessment test
时间窗: Baseline, months 1 and 2 follow up calls, 3 months and 6 months
COPD health status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control.
Change in COPD health status/health-related quality of life as assessed by the Clinical COPD Questionnaire health-related quality of life questionnaire
时间窗: Baseline, months 1 and 2 follow up calls, 3 months and 6 months
The Clinical COPD Questionnaire (CCQ) health-related quality of life questionnaire (HRQoL) with good psychometric properties. The CCQ consists of 10 items with an overall score and 3 domains: Symptoms (4 items), Functional state (4 items) and Mental state (2 items). High scores indicate worse quality of life.
次要结局
- Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1)(Baseline, 3 months and 6 months)
- Change in Quality of Life as assessed by the St. George's Respiratory Questionnaire(Baseline, 3 months and 6 months)
- Change in the number of exacerbation episodes reported due to moderate and/or severe COPD-related exacerbations(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) percent predicted(Baseline, 3 months and 6 months)
- Change in exercise capacity as assessed by the Six-Minute Walk Distance(Baseline, 3 months and 6 months)