Screening and Management of Adults With Asthma and Allergic Diseases

Overview

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

• Behavioral Allergen 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.
• Behavioral Exercise 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.
• Behavioral Dietary 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.
• Behavioral Allergen 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.
• Behavioral Dietary 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.
• Behavioral Exercise 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.

Primary outcome measures

• Asthma Control Test [Time frame: 3 months]
• Quality of life score [Time frame: 3 months]

Secondary outcome measures (2)

• Drug usage [Time frame: 3 months]
• Acute asthma exacerbation [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07523724 · CAMS&PUMC-IEC-2025-040

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗