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Sports-and-Medicine Integrated Diabetes Prevention and Control Study: A cluster-randomized controlled trial

Key technology of sports-and-medicine integrated management on diabetes using training station and 5G+ system: A research on the prevention and control of diabetes based on Sports-and-Medicine Integrated care model: A multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081848
Enrollment
Unknown
Registered
2024-03-13
Start date
2024-03-14
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes, and Diabetes, separately

Interventions

Intervention group (Diabetes prevention study):1. Participants in the intervention group were given an individualized exercise prescription (including frequency, intensity, time, and types) following
2. One session of exercise training guided by trained general practitioners, including education on how to evaluate exercise intensity using perceived exertion, self-counted pulse rate, or heart rate
Participants were encouraged to achieve the recommended amount of physical activity, defined as at least 150 minutes per week of exercise at the prescribed intensity according to the individualized ex
Control group (Diabetes prevention study):The control group received general public health services for diabetes management, including diet and exercise advice, medication guidance, and encouraging pa
Intervention group (Diabetes control study) :1.Participants in the intervention group were g

Sponsors

Zhongda Hospital, Affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for primary healthcare centers and participating villages: (1) Primary healthcare centers must have the relevant equipment for exercise assessment and intervention, body composition measurement, and screening for chronic diabetes complications (such as fundus examination and vibration perception threshold tests); (2) Each primary healthcare center must have at least one exercise prescription specialist and one diabetes education nurse; (3) Each participating village must have at least one village clinic equipped with the appropriate village doctor; (4) Participating villages/streets/communities must be at least 2 kilometers away from other participating villages; (5) Each village/street/community in the intervention group must have at least one health worker (village doctor, social worker, or fitness instructor). 2. Inclusion criteria for participants: (1) Permanent residents aged 30-70 years; (2) Good compliance and willingness to cooperate with examinations and follow-up; (3) Basic literacy skills; (4) Diagnostic criteria for prediabetes: Patients meeting any of the following criteria according to the American Diabetes Association (ADA) guidelines are diagnosed as prediabetic: fasting plasma glucose (FPG) between 5.6 and 6.9 mmol/L; 2-hour plasma glucose (2hPG) during OGTT between 7.8 and 11.0 mmol/L; HbA1c between 5.7% and 6.4%. (5) Diagnostic criteria for diabetes: Meets the diagnostic standards outlined in the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes" (2020 edition).

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for primary healthcare centers and participating villages: (1) Villages/streets under the jurisdiction of the primary healthcare center are fewer than 4; (2) Villages with a permanent resident population of fewer than 300 people. 2. Exclusion criteria for participants Exclusion criteria for prediabetes participants: (1) Using hypoglycemic drugs such as metformin for diabetes prevention or using GLP-1 receptor agonists for weight loss; (2) Previously diagnosed cardiovascular diseases (such as coronary heart disease, myocardial infarction, heart failure, unstable angina, cerebral hemorrhage, cerebral infarction, etc.) or suspected cardiovascular disease (such as experiencing significant chest tightness or pain during daily activities, shortness of breath or palpitations after minor exertion, or lower limb pain while walking that requires rest); (3) Had fractures or bone/joint-related surgery in the past six months; (4) History of multiple falls in the past six months, or needing rest due to health conditions; (5) Unstable conditions: such as uncontrolled hypertension (blood pressure >160/100mmHg), severe liver or kidney dysfunction, acute exacerbation of chronic obstructive pulmonary disease, etc.; (6) Mental disorders preventing cooperation (including dementia, etc.). Exclusion criteria for diabetes participants: (1) People with well-controlled glycated hemoglobin (HbA1c) (i.e., HbA1c 13.0%; (2) Previously diagnosed cardiovascular diseases (such as coronary heart disease, myocardial infarction, heart failure, unstable angina, cerebral hemorrhage, cerebral infarction, etc.) or suspected cardiovascular disease (such as experiencing significant chest tightness or pain during daily activities, shortness of breath or palpitations after minor exertion, or lower limb pain while walking that requires rest); (3) Had fractures or bone/joint-related surgery in the past six months; (4) History of multiple falls in the past six months, or needing rest due to health conditions; (5) Unstable conditions: such as uncontrolled hypertension (blood pressure >160/100mmHg), severe liver or kidney dysfunction, acute exacerbation of chronic obstructive pulmonary disease, etc.; (6) Mental disorders preventing cooperation (including dementia, etc.).

Design outcomes

Primary

MeasureTime frame
Incidence rate of diabetes (for diabetes prevention study) ;Control rate of target HbA1c;

Secondary

MeasureTime frame
Changes in metabolic markers (for diabetes prevention study);Exercise safety (for diabetes prevention study);Exercise adherence (for diabetes prevention study);Control rate of metabolic markers;Changes in metabolic markers (for diabetes control study);Incidence rate of diabetic complications;Control rate of metabolic markers;Exercise safety (for diabetes control study);Exercise adherence (for diabetes control study);

Countries

China

Contacts

Public ContactZilin Sun

Zhongda Hospital, Affiliated to Southeast University

sunzilin1963@126.com+86 139 5174 9490

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026