- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07603206
Replacing Gas Stoves With Portable Electric Appliances to Improve Indoor Air Quality and Asthma Control
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Cooking on natural gas stoves is a major source of indoor air pollution and may contribute to asthma exacerbations. The investigators recently completed a single-arm trial in which gas stoves were replaced with electric induction stoves in the homes of 85 individuals with poorly controlled asthma. This led to 70% reductions in indoor NO2 levels and clinically important improvements in multiple measures of asthma control. Asthma Control Questionnaire scores improved by 1.1 points in this trial, which is twice as large as the average improvement seen with medical treatment such as inhaled corticosteroids and/or long-acting beta-agonists.
While these results are promising, the trial lacked a control group which limits the causal inferences that can be drawn. In addition, lung function was not directly measured. Moreover, the costs for stove installation and required electrical upgrades averaged nearly $10,000 per home. Most of this cost was related to the older housing stock of trial participants that often required upgrading the entire electrical panel in a house to install a new 240-volt kitchen outlet for the new electric stove. These costs can be a financial challenge for low-income households, limiting the scalability of a potentially effective solution for improving indoor air quality and asthma control.
To address these limitations, the investigators now propose a pilot randomized controlled trial using a delayed crossover design to evaluate the effectiveness of a low-cost intervention to improve indoor air quality, asthma control, and lung function. The investigators will leave gas stoves in place but will instruct participants to preferentially use two relatively inexpensive portable electric appliances that the investigators will provide. Cooking will be done with an electric induction hot plate and baking with an electric toaster oven. Induction hot plates use magnetic coils beneath a ceramic glass surface to send electromagnetic pulses directly to cookware. The investigators will provide induction stove compatible cookware because it is necessary to use cookware that has some steel or iron in order for the energy transfer to work.
The two portable electric appliances and induction cookware are estimated to cost approximately $600 in total and may provide a more affordable option for low-income households. If a household already has a microwave oven, they will be encouraged to use that as well. As the future scalability of the intervention will depend on its usage, the investigators will also evaluate usage and identify facilitators and barriers to consistent use of the portable devices.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Ash Sehgal, MD
- Номер телефона: 216-778-7728
- Электронная почта: axs81@cwru.edu
Учебное резервное копирование контактов
- Имя: Ther Aung, PhD
- Номер телефона: 216-778-4061
- Электронная почта: taung@metrohealth.org
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Currently use gas stove for cooking or baking at least three times a week
- Poorly controlled asthma as defined by an Asthma Control Questionnaire score of 1.5 or larger
Exclusion Criteria:
- Impaired decision making capacity
- Pregnancy
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Immediate Intervention
Participants will receive electric hotplate and electric toaster oven immediately after enrollment.
|
The investigators will leave gas stoves in place but will instruct participants to preferentially use two relatively inexpensive portable electric appliances that the investigators will provide.
Cooking will be done with an electric induction hot plate and baking with an electric toaster oven.
|
|
Экспериментальный: Delayed Intervention
Participants will receive electric hotplate and electric toaster oven six months after enrollment.
|
The investigators will leave gas stoves in place but will instruct participants to preferentially use two relatively inexpensive portable electric appliances that the investigators will provide.
Cooking will be done with an electric induction hot plate and baking with an electric toaster oven.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in asthma control
Временное ограничение: Baseline assessment 1-2 weeks before portable appliances given to participant. Final assessment 2-3 months after portable appliances given to participant.
|
Change in Asthma Control Questionnaire score from baseline to final assessment.
Asthma Control Questionnaire scores can range from 0 to 6 with higher scores indicating poor asthma control.
|
Baseline assessment 1-2 weeks before portable appliances given to participant. Final assessment 2-3 months after portable appliances given to participant.
|
|
Change in indoor nitrogen dioxide levels
Временное ограничение: Baseline assessment 1-2 weeks before portable appliances given to participant. Final assessment 2-3 months after portable appliances given to participant.
|
Change in nitrogen dioxide level from baseline to final assessment
|
Baseline assessment 1-2 weeks before portable appliances given to participant. Final assessment 2-3 months after portable appliances given to participant.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in forced expiratory volume in 1 second (FEV1)
Временное ограничение: Baseline assessment 1-2 weeks before portable appliances given to participant. Final assessment 2-3 months after portable appliances given to participant.
|
Changes in FEV1 from baseline to final assessment.
|
Baseline assessment 1-2 weeks before portable appliances given to participant. Final assessment 2-3 months after portable appliances given to participant.
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Bime C, Nguyen J, Wise RA. Measures of asthma control. Curr Opin Pulm Med. 2012 Jan;18(1):48-56. doi: 10.1097/MCP.0b013e32834db0f2.
- Audignon-Durand S, Ramalho O, Mandin C, Roudil A, Le Bihan O, Delva F, Lacourt A. Indoor exposure to ultrafine particles related to domestic activities: A systematic review and meta-analysis. Sci Total Environ. 2023 Dec 15;904:166947. doi: 10.1016/j.scitotenv.2023.166947. Epub 2023 Sep 9.
- Lebel ED, Finnegan CJ, Ouyang Z, Jackson RB. Methane and NOx Emissions from Natural Gas Stoves, Cooktops, and Ovens in Residential Homes. Environ Sci Technol. 2022 Feb 15;56(4):2529-2539. doi: 10.1021/acs.est.1c04707. Epub 2022 Jan 27.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY00001017
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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