Allergic Disease, Asthma
Conditions
Keywords
Allergic diseases, Asthma, Questionnaire development and validation, Digital health, China
Brief summary
The aim of this study is to develop and validate a digital screening tool and digital management system for asthma and allergic diseases among Chinese adults and to evaluate the effectiveness of integrated non-pharmacological interventions in improving disease control and quality of life. The digital management cohort consists of: * At least 12 months of longitudinal monitoring of symptoms, environmental exposures, and health behaviors via a digital platform, supplemented by regular clinical assessments. * 3x embedded randomized controlled trials (RCTs) evaluating the clinical efficacy of non-pharmacological strategies: allergen avoidance (anti-mite bedding), physical activity (wearable-guided exercise), and dietary management (Mediterranean diet).
Detailed description
Early identification and sustained management are crucial for mitigating the growing public health burden of asthma and allergic diseases. This study implements a coherent system spanning from population-level assessment to individualized, long-term care. The primary objectives are to: Validate a culturally adapted screening questionnaire and an integrated digital health platform for the Chinese population. Establish a prospective longitudinal cohort to investigate disease progression and evaluate the clinical efficacy of non-pharmacological interventions via embedded randomized controlled trials (RCTs). The investigators will enroll approximately 9,666 first-year university students into a hybrid study that combines a digital cohort with targeted intervention trials. Following initial tool validation, large-scale screening will be conducted during entrance health check-ups. Individuals identified through screening or with self-reported allergic conditions will be invited to join a longitudinal management cohort for at least one year of follow-up. Within this monitoring framework, eligible participants will be recruited into three distinct embedded RCTs evaluating non-pharmacological strategies: * Allergen Avoidance: Evaluating the impact of weekly anti-mite bedding replacement and HEPA vacuuming. * Exercise Intervention: An 8-week behavioral program using wearable activity trackers to improve outcomes for sedentary adults with asthma. * Dietary Intervention: A 12-week study assessing the effects of a Mediterranean diet on asthma control. Longitudinal follow-up utilizes a mixed-methods strategy, integrating passive self-reporting every 3 months via the digital platform with active researcher-led assessments every 6 months, including clinical laboratory testing (IgE, FeNO) and spirometry. This approach allows for the investigation of complex interactions between genetic susceptibility and environmental exposures in disease expression.
Interventions
BEHAVIORALAllergen Avoidance Intervention - group 1
Participants received standardized allergen avoidance measures, with the primary goal of reducing allergen exposure levels. Specific measures included regularly implementing allergen avoidance behaviors and recording environmental parameters. The operational details were carried out in accordance with the research protocol. During the intervention period, the original medication treatment was maintained.
BEHAVIORALExercise Intervention - group 1
Participants receive a standardized exercise promotion program, which included, but is not limited to, regular face-to-face guidance, motivational interviews, personalized goal setting, action planning, and self-feedback and adjustment based on objective activity monitoring data. During the intervention period, the subjects maintain their original medication treatment plans unchanged.
BEHAVIORALDietary Intervention - group 1
Participants receive standardized guidance on a healthy diet pattern. The intervention measures included, but are not limited to, guidance from nutritionists, provision of food materials, and monitoring of dietary compliance. During the intervention period, the subjects maintain their original medication treatment plans unchanged.
BEHAVIORALAllergen Avoidance Intervention - group 2
Participants eceive usual care, consisting of standard pharmacological treatment. They are instructed to maintain their baseline lifestyle and activity levels without participating in additional allergen avoidance interventions.
BEHAVIORALDietary Intervention - group 2
Participants continue their routine clinical treatment and do not receive dietary interventions. At baseline, all participants watch a 10-minute asthma self-management education video that does not contain dietary advice.
BEHAVIORALExercise Intervention - group 2
Participants receive usual care, consisting of standard pharmacological treatment. They are instructed to maintain their baseline lifestyle and activity levels without participating in additional exercise interventions.
Sponsors
Beijing Hospital
Chinese Academy of Medical Science & Peking Union Medical College School of Population Medicine and Public Health
Jilin University
The First Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
3 randomised controlled trials (RCTs), embedded within the cohort study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 years * Capable of providing informed consent and completing the questionnaire independently.
Exclusion criteria
* Individuals with serious chronic diseases, immune disorders, or severe psychiatric/cognitive conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test | 3 months | Patient health-related outcomes, specifically the level of asthma control, were measured using the pre-validated Asthma Control Test (ACT). This tool consists of 5 questions, each scored on a scale from 1 to 5. A total score of 19 or less indicates that the patient's asthma may not be well-controlled, signaling a need for clinical re-evaluation and potential adjustments to their treatment regimen. A score of 15 or less suggests that the asthma is poorly controlled or completely uncontrolled. |
| Quality of life score | 3 months | Change in Asthma Quality of Life Questionnaire score in the intervention group. Values range 7-224, with higher scores indicating better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug usage | 3 months | The usage of drugs during the follow-up period |
| Acute asthma exacerbation | 3 months | An acute asthma exacerbation is characterized by a rapid onset or progressive worsening of symptoms-including wheezing, dyspnea, chest tightness, and coughing-accompanied by a decline in lung function. |
Contacts
CONTACTXunliang Tong, MD
CONTACTYating Wang
Outcome results
None listed