Digital Intervention, Hyperglycemia, Hyperlipidemia, Hypertension, Hyperuricemia
Conditions
Keywords
Digitally-Enabled Health, Chronic Disease Prevention and Control, Sports prescription, Primary health care (PHC)
Brief summary
This study conducted a six-month exploratory clinical trial to evaluate the impact of an exercise prescription mini-program, based on the "Exercise Guidelines for the 'Four Highs'", on the physical activity levels and related health indicators of patients with hypertension, hyperglycemia, hyperlipidemia, and hyperuricemia in primary healthcare settings in China.
Interventions
BEHAVIORALEnhanced Mini-Program Intervention
physician training/assessment + patient exercise guidance via the mini-program + patient social support group activities
BEHAVIORALEnhanced Control
physicians receiving training/assessment in addition to conducting patient exercise guidance autonomously
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older. 2. Willing to participate in the study and able to provide written informed consent. 3. Diagnosed with at least one of the following "Four Highs" conditions: Hypertension: Diagnosed primary hypertension, defined as seated office SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg on at least three non-consecutive days, or currently taking antihypertensive medication. Blood pressure must be controlled while on four or more antihypertensive agents. Diabetes Mellitus: Diagnosed diabetes, defined as having typical symptoms plus random plasma glucose ≥ 11.1 mmol/L, or fasting plasma glucose ≥ 7.0 mmol/L, or 2-hour plasma glucose during OGTT ≥ 11.1 mmol/L, or HbA1c ≥ 6.5%, or currently taking glucose-lowering medication. HbA1c level must be between 6.5% and 13.0%. Hyperlipidemia: Diagnosed hyperlipidemia, defined as total cholesterol (TC) ≥ 6.22 mmol/L, or LDL-C ≥ 4.14 mmol/L, or HDL-C \< 1.04 mmol/ L, or triglycerides (TG) \> 2.26 mmol/L, or currently taking lipid-lowering medication. Hyperuricemia: Diagnosed hyperuricemia, defined as a fasting serum uric acid level \> 420 μmol/L (7 mg/dL) in men and postmenopausal women, or \> 360 μmol/L (6 mg/dL) in premenopausal women, on two non-consecutive days under a normal purine diet, or currently taking urate-lowering medication. 4. Capable of using a smartphone. 5. A local permanent resident who receives basic public health service management at the designated community health center/station or township hospital. 6. Has not engaged in regular moderate- to vigorous-intensity physical activity (defined as at least 30 minutes per session, on at least 3 days per week) in the past three months.
Exclusion criteria
Patients meeting any of the following criteria will be excluded: 1. History or acute episode of cardiovascular or cerebrovascular disease, including: angina pectoris, myocardial infarction, coronary revascularization surgery, stroke (ischemic or hemorrhagic, including transient ischemic attack), symptomatic peripheral arterial disease requiring surgery or diagnosed by vascular imaging, ventricular arrhythmia, uncontrolled atrial fibrillation, congestive heart failure (New York Heart Association Class III or IV), hypertrophic cardiomyopathy, history of aneurysm with diameter ≥ 5.5 cm or prior aneurysm surgery. 2. Current malignant tumor or history of malignant tumor within the past five years. 3. Contraindications to exercise, such as bone and joint diseases. 4. Severe respiratory diseases, including asthma, chronic obstructive pulmonary disease (COPD), restricted lung volume (due to obesity, pregnancy, or spinal deformity), or cystic fibrosis. 5. Neuromuscular and degenerative diseases, such as muscular dystrophy, poliomyelitis, and dementia. 6. Severe mental illness, including schizophrenia, bipolar disorder, eating disorders, or depression (with hospitalization for the condition within the past 6 months). 7. Movement and other neurological disorders, such as Huntington's disease, torsion dystonia, Parkinson's disease, and certain epileptic disorders. 8. Severe comorbidities with a life expectancy of less than 24 months. 9. Plans to relocate from the area within the next three months. 10. Participation in other physical activity level intervention programs within the six months prior to the screening visit. 11. Current participation in another randomized clinical trial. 12. Any other condition that, in the investigator's judgment, may interfere with adherence to the trial protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean daily step count | from baseline to Month 3 | The calculation of changes in average daily step count is defined as the difference between the average daily step count during the 7-day period prior to intervention (hereafter referred to as "the pre-intervention week") and the average daily step count during the final 7-day period of the third intervention month (hereafter referred to as "the final intervention week") |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Average Daily Moderate-to-Vigorous Physical Activity (MVPA) Time (minutes/day) Measured by HLWH005 Accelerometer-Based Wearable | from baseline to Month 3 | Average daily time (minutes/day) spent in MVPA, defined as activity intensity \>100 steps/min, assessed using the HLWH005 accelerometer-based wearable device. MVPA will be calculated as the mean MVPA minutes per day over a 7-day monitoring period. The outcome is the change from the baseline 7-day period (pre-intervention week) to the final 7-day period of Month 3 (last week of intervention). |
| Change from Baseline in Maximum Handgrip Strength (kg) Measured by CAMRY EH101 Hand Dynamometer | from baseline to Month 3 | Maximum handgrip strength (kg) assessed using the CAMRY EH101 hand dynamometer. Grip strength will be measured in a standing position with the elbow extended and wrist in neutral position. Both hands will be assessed; each hand will be measured 3 times and the maximum value will be recorded. The outcome is the change from baseline to Month 3. |
| Change from Baseline in Body Mass Index (BMI) (kg/m²) Based on Measured Height and Weight | from baseline to Month 3 | BMI (kg/m²) calculated as weight (kg) / height (m)², using standard clinical measurements of body weight (calibrated digital scale) and height (stadiometer). The outcome is the change from baseline to Month 3. |
| Change from Baseline in Waist-to-Height Ratio (unitless) Based on Measured Waist Circumference and Height | from baseline to Month 3 | Waist-to-height ratio (unitless) calculated as waist circumference (cm) / height (cm). Waist circumference will be measured using a non-stretch measuring tape following standard clinical procedures; height will be measured using a stadiometer. The outcome is the change from baseline to Month 3. |
| Change from Baseline in Waist-to-Hip Ratio (unitless) Based on Measured Waist and Hip Circumference | from baseline to Month 3 | Waist-to-hip ratio (unitless) calculated as waist circumference (cm) / hip circumference (cm). Waist and hip circumference will be measured using a non-stretch measuring tape following standard clinical procedures. The outcome is the change from baseline to Month 3. |
| Change from Baseline in Resting Systolic Blood Pressure (mmHg) Measured by HELOWIN TE-7003Y-C Automated Arm Cuff | from baseline to Month 3 | Resting systolic blood pressure (mmHg) measured using the HELOWIN TE-7003Y-C automated upper-arm blood pressure monitor. After 5 minutes of seated rest, blood pressure will be measured 3 times at 5-minute intervals; the average of the 3 readings will be used. The outcome is the change from baseline to Month 3. |
| Change from Baseline in Glycated Hemoglobin (HbA1c) (%) Measured by Laboratory Assay | from baseline to Month 3 | HbA1c (%) measured from fasting venous blood samples analyzed at the local clinical laboratory using standard laboratory assay methods. The outcome is the change from baseline to Month 3. |
| Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) Concentration (mmol/L) Measured by Laboratory Assay | from baseline to Month 3 | LDL-C concentration (mmol/L) measured from fasting venous blood samples analyzed at the local clinical laboratory using standard laboratory assay methods. The outcome is the change from baseline to Month 3. |
| Change from Baseline in Serum Uric Acid Concentration (µmol/L) Measured by Laboratory Assay | from baseline to Month 3 | Serum uric acid concentration (µmol/L) measured from fasting venous blood samples analyzed at the local clinical laboratory using standard laboratory assay methods. The outcome is the change from baseline to Month 3. |
| High Adherence Rate to the Mini-Program-Based Exercise Plan (%) Assessed by Mini-Program Check-in Logs and Social-Support Attendance Records (Intervention Group Only) | from baseline to Month 3 | High adherence rate, defined as the percentage of participants in the mini-program intervention group who meet the pre-specified adherence criteria during the 3-month intervention period: (1) average weekly completion rate ≥70% for each of the three check-in modules ("aerobic exercise", "resistance exercise", and "step count") recorded in the mini-program logs; and (2) attendance at ≥2 monthly social-support group sessions recorded by attendance logs. |
Countries
China
Contacts
CONTACTTian
Outcome results
None listed