Health Promotion, Hypercholesterolemia and Hyperlipidemia, Hypertension (HTN), Hyperuricemia, Overweight (BMI > 25), Sleep Quality, Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
This study aims to evaluate the effectiveness of a digital health intervention for community-dwelling middle-aged and older adults in Taiwan. A total of 199 participants from four randomly selected communities will be enrolled in a 6-month cluster randomized trial. Participants in the intervention group will use smart devices to record physiological data, which are automatically uploaded to a cloud-based health management platform. Physicians will review the data monthly and provide personalized consultations and health education. Primary outcomes include anthropometric measures, biochemical indices, electrocardiograms, and self-reported health and sleep quality.
Detailed description
This 6-month cluster randomized trial is conducted in Guishan District, Taoyuan City, Taiwan, to examine the impact of a digital health intervention on community health outcomes among adults aged 50 years and older. From 32 eligible communities, four are randomly selected. Participants must have resided in the community for at least six months, be aged 50 years or older, and provide informed consent. Individuals with severe cognitive impairment, terminal illness, or an inability to use basic digital devices are excluded. Participants in the intervention group will use smart devices to measure blood pressure, fasting glucose, uric acid, total cholesterol, and electrocardiograms. The data are automatically synchronized with a cloud-based health management platform. Physicians will review data monthly and provide individualized consultations and health education sessions at baseline, 3 months, and 6 months. Primary outcomes include anthropometric indices (BMI, body fat percentage, visceral fat rating, skeletal muscle mass index), biochemical markers (fasting glucose, uric acid, cholesterol), and self-reported health and sleep quality. Secondary outcomes include trends in physiological indicators and associations among cardiometabolic risk factors. Ethical approval was obtained from the Institutional Review Board of Chang Gung Memorial Hospital (IRB No.: 202201534B0). Written informed consent is obtained from all participants.
Interventions
DEVICEDigital Health Program with Smart Devices
Participants in the intervention group used smart devices to measure physiological parameters, including blood pressure, blood glucose, uric acid, cholesterol, and electrocardiograms. These data were automatically uploaded to a cloud-based health management platform. Physicians reviewed the data monthly and provided personalized consultations and health education for 6 months.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 50 years and older * Resided in the community for at least 6 months * Able and willing to provide written informed consent
Exclusion criteria
* Severe cognitive impairment * Terminal illness * Inability to operate basic digital devices (e.g., smartphone, health monitoring device) * Declined to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Blood Glucose | Baseline, 3 months, 6 months | Measurement: Laboratory glucose value in milligrams per deciliter (mg/dL). Range: Typically 50-500 mg/dL observed in human plasma. Directionality: Higher values indicate worse glycemic control. Abnormal thresholds: FPG ≥ 100 mg/dL or PPG ≥ 140 mg/dL (American Diabetes Association criteria). |
| Change in Blood Pressure (Systolic and Diastolic) | Baseline, 3 months, 6 months | Measurement: Systolic (mmHg) and diastolic (mmHg). Range: 70-250 mmHg (SBP); 40-150 mmHg (DBP). Directionality: Higher values indicate worse blood-pressure control. Abnormal threshold: SBP ≥ 130 mmHg or DBP ≥ 80 mmHg (2017 ACC/AHA guideline). |
| Change in Serum Uric Acid | Baseline, 3 months, 6 months | Measurement: Serum uric-acid concentration (mg/dL). Range: 2-12 mg/dL. Directionality: Higher values indicate worse metabolic status. Abnormal threshold: \> 7.0 mg/dL. |
| Change in Body Mass Index (BMI) | Baseline, 3 months, 6 months | Measurement: Weight (kg) / height² (m²). Range: 10-60 kg/m². Directionality: Higher values indicate greater adiposity. Abnormal threshold: ≥ 24 kg/m² (Taiwanese overweight criterion). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Fat Percentage | Baseline, 3 months, 6 months | Measurement range: 5-60 %. Directionality: Higher values indicate worse body-composition status. Abnormal threshold: ≥ 25 % (men) or ≥ 30 % (women). |
| Change in Sleep Quality (Pittsburgh Sleep Quality Index, PSQI) | Baseline, 3 months, 6 months | Scale title: Pittsburgh Sleep Quality Index (PSQI), 19-item standardized questionnaire evaluating sleep over the previous month. Scale range: 0-21 points. Directionality: Higher scores indicate worse sleep quality. Interpretation: Total score \> 5 = poor sleep quality. |
| Change in Visceral Fat Rating | Baseline, 3 months, 6 months | Scale range: 1-59 points. Directionality: Higher scores indicate worse (greater) visceral-fat accumulation. Abnormal threshold: ≥ 10 points. |
| Change in Skeletal Muscle Mass Index (ASMI) | Baseline, 3 months, 6 months | Measurement: Skeletal-muscle mass / height² (kg/m²). Typical range: 4.0-10.0 kg/m². Directionality: Higher values indicate better muscle mass. Cut-offs (AWGS 2019): \< 7.0 kg/m² (men) or \< 5.7 kg/m² (women) = low muscle mass. |
| Change in Self-Rated Health Status | Baseline, 3 months, 6 months | Scale title: Self-Rated Health Scale (single-item global health question). Scale range: 1 = Excellent, 2 = Good, 3 = Fair, 4 = Poor, 5 = Very Poor. Directionality: Higher scores indicate worse perceived overall health. |
Countries
Taiwan
Outcome results
None listed