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A three-arm cluster randomized controlled trial to evaluate the effectiveness of digital-based lifestyle intervention and complex intervention on the prevention of type 2 diabetes and reversion to normoglycemia in adults with screen detected prediabetes

Daqing Diabetes Prevention Study II

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080790
Enrollment
Unknown
Registered
2024-02-07
Start date
2024-04-11
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Prediabetes

Interventions

Usual care:The usual care group comprises a single face-to-face education session, lifestyle guidance based on WeChat public accounts, and general health communication, such as posting bulletin boards
Digital-based lifestyle intervention:The digital-based lifestyle intervention group, in addition to including the content of the usual care group, also encompasses lifestyle guidance based on mobile t
Complex intervention:The complex intervention group, beyond including the elements of both the usual care group and the digital-based intervention group, also incorporates face-to-face lifestyle couns

Sponsors

Chinese Academy of Medical Sciences & Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 55 Years

Inclusion criteria

Inclusion criteria: ?Participants aged 25-55 years; ?Prediabetes defined as impaired fasting glucose (fasting plasma glucose 6.1–6.9mmol/L), impaired glucose tolerance (2-h plasma glucose 7.8–11.0 mmol/L during oral glucose tolerance test [OGTT]), elevated HbA1c (5.7%-6.4% [39-47 mmol/mol]) or intermediate hyperglycemia(1hPG=8.6mmol/L); ?Staff in the Daqing Oilfield Production; ?Possibility to use a computer, smartphone, or tablet with internet connection; ?Willingness to sign the written informed consent form.

Exclusion criteria

Exclusion criteria: ?Documented presence of diabetes; ?Women who were pregnant, lactating, or planning to become pregnant in the next 36 months; ?Taking medications that could alter glucose metabolism within six months; ?Persistent uncontrolled hypertension (SBP =160 mmHg or DBP =100 mmHg); ?Subjects with a total knee or hip replacement in either limb within 3 months; ?Significant CVD within 6 months (acute myocardial infarction, Class III/IV congestive heart failure defined by the New York Society of Cardiology, left ventricular ejection fraction =40% or cerebrovascular accident); ?Active cancer or less than 6 months from cancer treatment; ?Impaired liver function (including obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, ALT or AST levels =3 times the upper limit of the reference range at the screening visit); ?Renal dysfunction (eGFR <45 mL/min); ?Diseases related to glucose metabolism disorder (e.g., Cushion's syndrome); ?Participation in projects involving lifestyle modifications or other clinical trials within 30 days; ?Any other significant medical or psychological condition that could endanger the health of the participant or confound the study results if the participant was enrolled.

Design outcomes

Primary

MeasureTime frame
Diabetes incidence rate;Reversion to normoglycemia;

Secondary

MeasureTime frame
Fasting plasma glucose;2-h plasma glucose during oral glucose tolerance test;Hemoglobin A1C (HbA1c);Weight;Body Mass Index;Waist Circumference;Dietary behavior;Physical activity;Sleep quality;Tobacco and alcohol use;Knowledge of prediabetes;Psychological status;Self-efficacy;Social support;Health related life quality;

Countries

China

Contacts

Public ContactRuitai Shao

School of Population Medicine and Public Health, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

shaoruitai@cams.cn+86 139 1164 4595

Outcome results

None listed

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