Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/07/2016
Date assigned
03/08/2016
Last edited
03/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Type 2 diabetes mellitus (T2DM) is a growing problem worldwide. People with T2DM have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). T2DM is linked to a number of severe complications, as well as increasing the risk of heart disease (cardiovascular disease) and cancer. In recent years, greater stress is being put on diabetes prevention, by encouraging people to change their lifestyles to reduce their risk of developing the disease. A number of studies have looked at the benefits of individual counseling, however this can be expensive and isn’t always relevant to ‘real life’. This study will look at a diabetes prevention program which combines group activities and motivational follow up to encourage healthier lifestyle choices. The aim of this study is to find out if this diabetes prevention program is an effective way of reducing diabetes risk.

Who can participate?
Adults aged 25 years or over who live in Kraków and have a high risk of developing diabetes.

What does the study involve?
Participants are invited to take part in a ten month diabetes prevention course run by a trained nurse. The course involves a combination of group sessions, focusing on changing diet and exercise habits, six motivational telephone sessions, two motivational letters and the opportunity to take part in exercise sessions twice a week. The course stresses the importance of social support and family members or spouses are also able to take part in the sessions. At the start of the study and then after 12 and 36 months, participants have their diabetes risk assessed by having their blood sugar control tested through a series of blood tests, having weight and blood pressure measurements taken, and completing a range of questionnaires. The cost effectiveness of the course is assessed at the end of the study by recording the costs of all activities involved.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved for participants taking part in this study.

Where is the study run from?
The study is coordinated by Jagiellonian University and takes place in nine Primary Health Care Centers in Kraków (Poland)

When is the study starting and how long is it expected to run for?
January 2006 to January 2014

Who is funding the study?
The Commission of the European Communities, Directorate C - Public Health (Belgium)

Who is the main contact?
Dr Aleksandra Gilis-Januszewska
myjanusz@cyfronet.pl

Trial website

www.ktl.fi/deplan - no longer active

Contact information

Type

Scientific

Primary contact

Dr Aleksandra Gilis-Januszewska

ORCID ID

http://orcid.org/0000-0002-9982-6499

Contact details

Chair and Department of Endocrinology
Jagiellonian University
Medical College
Kopernika str 17
Krakow
31-501
Poland
+48 505 164 348
myjanusz@cyfronet.pl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DEPLAN/PR1.02/2007

Study information

Scientific title

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

Acronym

DE-PLAN

Study hypothesis

Hypothesis:
The translation of the current research evidence about diabetes preventive intervention programmes into clinical settings within existing health care systems in Europe is feasibile and cost-effective.

Study aim:
The aim of this study is to develop and test models of efficient identification and site specific intervention of individuals at high risk of type 2 diabetes in the community.

Ethics approval

Ethical Commitee of Jagiellonian University, 23/03/2006, ref: KBET/43/L/2006

Study design

Non-randomised interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not longer available in web format, please use contact details to request a participant information sheet

Condition

Prediabetes, high diabetes risk

Intervention

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 on reinforced behaviour modification focusing on five lifestyle goals: weight loss, reduced intake of total and saturated fats, increased consumption of fruits, vegetables and fibre and increased physical activity.

A trained nurse certified in diabetes prevention delivers the intervention over a period of 10 months. This involves 10 group sessions focusing on diet and physical activity changes, six motivational telephone sessions, two motivational letters and the opportunity to participate twice weekly in physical activity sessions, over a period of 10 months. During each session, printed educational materials related to the topic of the session are distributed. Social support is emphasised in the group setting and participants are also encouraged to involve their own social circle in the lifestyle changes. A spouse or other family member can also participate in the sessions.

Patients are examined at baseline, after 12 and 36 months of initiation of the study. Questionnaires (FINDRISC, clinical and lifestyle and Quality of life) and biochemical tests including fasting and 120’OGTT glucose, serum triglycerides, HDL and total cholesterol, as well as body mass index (BMI), waist circumference, diastolic and systolic blood pressure are measured. Lifestyle changes are explored with the use of self reported questionnaire (consumption of vegetables and fruits, fat and saturated fat, alcohol and physical activity during the past year).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/01/2006

Overall trial end date

01/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

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

Recruitment start date

01/01/2006

Recruitment end date

01/01/2009

Locations

Countries of recruitment

Poland

Trial participating centre

Jagiellonian University
Department of Endocrinology Medical College Kopernika 17
Krakow
31-501
Poland

Trial participating centre

Niepubliczny Zakład Opieki Medicina
Rogozińskiego 12
Kraków
31-559
Poland

Trial participating centre

Niepubliczny Zakład Opieki Zdrowotnej Praktyka Lekarza Rodzinnego
Inicjatywy lokalnej 5
Kraków
30-499
Poland

Trial participating centre

Niepubliczny Zakład Opieki Centrum Medyczne Prokocim Nowy
Teligi 8
Kraków
30-835
Poland

Trial participating centre

Niepubliczny Zakład Opieki Centrum Medyczne Nowa-Huta
Ujastek 3
Kraków
30-969
Poland

Trial participating centre

Niepubliczny Zakład Opieki Przychodnia Na Wzgórzach
Na Wzgórzach 1
Kraków
31-721
Poland

Trial participating centre

Niepubliczny Zakład Opieki Praktyka Grupowa Lekarzy Rodzinnych
Bocheńska 4
Kraków
30-500
Poland

Trial participating centre

Firma Marketingowo - Medyczna, Niepubliczny Zakład Opieki Mark- Med
Na Skarpie 27/211 a
Kraków
31-911

Trial participating centre

Praktyka Grupowa Lekarzy Rodzinnych
2 Pułku Lotniczego 22
Kraków
31-869
Poland

Trial participating centre

Niepubliczny Zakład Opieki "Przychodnia Salwatorska"
Komorowskiego 12
Kraków
30-106
Poland

Sponsor information

Organisation

The Commission of the European Communities, Directorate C - Public Health

Sponsor details

Rue de la Loi/Wetstraat 175
Brussel
B-1048
Belgium
+32 2 281 61 11
EU@communi-k.eu

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

The Commission of the European Communities, Directorate C - Public Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Data on the one year results were published in 2011. Data on the 3 year results are planned to be published in 2016.

Intention to publish date

01/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes