Diabetes in Europe - Prevention using Lifestyle, physical Activity and Nutritional intervention (DE-PLAN) project

The feasibility and cost effectiveness of screening and prevention of type 2 diabetes by lifestyle intervention in real life community setting within existing health care systems in Europe: Diabetes in Europe Prevention using Lifestyle, physical Activity and Nutritional intervention (DE-PLAN) project

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN96692060

Enrollment

300

Registered

2016-08-03

Start date

2006-01-01

Completion date

Unknown

Last updated

2023-09-26

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

Conditions

Prediabetes, high diabetes risk Nutritional, Metabolic, Endocrine Prediabetes, high diabetes risk

Interventions

Patients fulfilling the inclusion criteria are invited to participate in the lifestyle intervention consisting of two parts: an intensive initial phase followed by an ongoing maintenance phase, based

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 25 years and over 2. Krakow city inhabitants 3. High diabetes risk (Finnish Diabetes Risk Score (FINDRISC) >14)

Exclusion criteria

Exclusion criteria: 1. Known or oral glucose tolerance test (OGTT) screened diabetes 2. Known chronic disease

Design outcomes

Primary

Measure	Time frame
Type 2 diabetes mellitus risk is measured at baseline, 12 and 36 months using metabolic and anthropometric indices and questionnaires: Biochemical tests: 1. Fasting glucose mmol/l 2. 120’OGTT glucose mmol/l 3. Serum triglycerides mmol/l 4. HDL cholesterol mmol/l 5. Total cholesterol mmol/l Anthropometric measurements: 1. Body mass index (BMI), calculated as weight divided by height squared 2. Waist circumference (cm), measured midway between the lowest rib and iliac crest 3. Blood pressure (mmHg), measured while sitting after 10 minutes rest Questionnaires: 1. Finnish Diabetes Risk Score (FINDRISC) questionnaire 2. Questionnaire measuring lifestyle (specially designed for the purpose of this study) 3. Questionnaire measuring sociodemographic data regarding, education, marital status, working status, smoking (specially designed for the purpose of this study) 4. Questionnaire measuring current health status, history of elevated glucose level, cardiovascular disease, hypertension, hyperlipidemia, depression, other chronic conditions, currently taken medication. family history of diabetes (specially designed for the purpose of this study)	—

Measure

Time frame

Type 2 diabetes mellitus risk is measured at baseline, 12 and 36 months using metabolic and anthropometric indices and questionnaires: Biochemical tests: 1. Fasting glucose mmol/l 2. 120’OGTT glucose mmol/l 3. Serum triglycerides mmol/l 4. HDL cholesterol mmol/l 5. Total cholesterol mmol/l Anthropometric measurements: 1. Body mass index (BMI), calculated as weight divided by height squared 2. Waist circumference (cm), measured midway between the lowest rib and iliac crest 3. Blood pressure (mmHg), measured while sitting after 10 minutes rest Questionnaires: 1. Finnish Diabetes Risk Score (FINDRISC) questionnaire 2. Questionnaire measuring lifestyle (specially designed for the purpose of this study) 3. Questionnaire measuring sociodemographic data regarding, education, marital status, working status, smoking (specially designed for the purpose of this study) 4. Questionnaire measuring current health status, history of elevated glucose level, cardiovascular disease, hypertension, hyperlipidemia, depression, other chronic conditions, currently taken medication. family history of diabetes (specially designed for the purpose of this study)

—

Secondary

Measure	Time frame
1. Quality of life is measured using the 15D HRQoL questionnaire at baseline, 12 and 36 months 2. Cost effectiveness is assessed by collecting the costs of screening and intervention activities (i.e. related personnel use, services provided, consumables, media costs, etc.) at 36 months	—

Countries

Poland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026