NCT07523724

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,666

participants targeted

Target at P75+ for not_applicable asthma

Timeline
16mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

April 6, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

Allergic diseasesAsthmaQuestionnaire development and validationDigital healthChina

Outcome Measures

Primary Outcomes (2)

  • Asthma Control Test

    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.

    3 months

  • Quality of life score

    Change in Asthma Quality of Life Questionnaire score in the intervention group. Values range 7-224, with higher scores indicating better quality of life.

    3 months

Secondary Outcomes (2)

  • Drug usage

    3 months

  • Acute asthma exacerbation

    3 months

Study Arms (6)

Allergen Avoidance Intervention - group 2

PLACEBO COMPARATOR
Behavioral: Allergen Avoidance Intervention - group 2

Exercise Intervention - group 2

PLACEBO COMPARATOR
Behavioral: Exercise Intervention - group 2

Dietary Intervention - group 2

PLACEBO COMPARATOR
Behavioral: Dietary Intervention - group 2

Allergen Avoidance Intervention - group 1

EXPERIMENTAL
Behavioral: Allergen Avoidance Intervention - group 1

Exercise Intervention - group 1

EXPERIMENTAL
Behavioral: Exercise Intervention - group 1

Dietary Intervention - group 1

EXPERIMENTAL
Behavioral: Dietary Intervention - group 1

Interventions

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.

Allergen Avoidance 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.

Exercise 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.

Dietary Intervention - group 1

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.

Allergen Avoidance 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.

Dietary 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.

Exercise Intervention - group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged ≥18 years
  • Capable of providing informed consent and completing the questionnaire independently.

You may not qualify if:

  • Individuals with serious chronic diseases, immune disorders, or severe psychiatric/cognitive conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 3 randomised controlled trials (RCTs), embedded within the cohort study.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share