Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/10/2013
Date assigned
30/10/2013
Last edited
14/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Effective strategies for diabetes prevention can be put into daily practice without spending a large amount of money and with less manpower. The Dutch Diabetes Federation developed a protocol (method) for coaching people with impaired (abnormal) fasting glucose to a sustainable healthy lifestyle change called ‘the road map towards diabetes prevention’ (abbreviated as RM for Road Map). This protocol is applied within a GP surgery by a general practitioner and a practice nurse. We aim to study the feasibility, effectiveness and cost-effectiveness of care provided according to the RM protocol.

Who can participate?
People with Impaired Fasting Glucose (IFG) and motivated to change their lifestyle can take part in this study.

What does the study involve?
GP practices were randomly allocated to one of two groups: intervention and control. After IFG is diagnosed, motivated people in the intervention practices received 3-4 consultations by the practice nurse within one year. During these consultations they were coached to increase their level of physical activity and adopt healthy dietary habits. If necessary, participants were referred to a dietician, physiotherapist, lifestyle programs and/or local sports activities. The control group received care as usual, including a yearly check on diabetes-related symptoms and blood glucose levels.

What are the possible benefits and risks of participating?
Improving the lifestyle of individuals with IFG to delay or even prevent the development of diabetes and associated heart disease-related risk factors.

Where is the study run from?
The study is run from more than 25 general practices located in the North-eastern region of the Netherlands. Only practices which employ a practice nurse are included.

When is the study starting and how long is it expected to run for?
The study started in May 2010 and ran until November 2012.

Who is funding the study?
The study is funded by the Ministry of Health, Wellbeing and Sports (VWS) (Netherlands) and the Netherlands Diabetes Federation (NDF) (Netherlands).

Who is the main contact?
Dr Arlette Hesselink
a.hesselink@rescon.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Arlette Hesselink

ORCID ID

Contact details

Kennemerplein 7
Haarlem
2011 MH
Netherlands
+31 (0)23 5310015
A.Hesselink@rescon.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A cluster-randomized controlled trial to study the effectiveness of a protocol-based lifestyle program to prevent type 2 diabetes in people with impaired fasting glucose

Acronym

Study hypothesis

To prevent type 2 diabetes, a protocol for coaching people with impaired fasting glucose (IFG; according to WHO criteria: 6.1 to 6.9 mmol/l) to a sustainable healthy lifestyle change is developed. This protocol is applied within a primary health care setting by a general practitioner and a practice nurse. The study hypothesis is that the protocol is feasible and cost-effective.

Ethics approval

Medical Ethics Committee Isala Klinieken, METC number: NL31342.075.10

Study design

Cluster randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 2 diabetes/impaired fasting glucose

Intervention

Randomisation is at the level of the general practices and they are followed up at one and two years.

Intervention group
General practices assigned to the intervention group apply a protocol called ‘the road map towards diabetes prevention’ (Road Map: RM). The first section of the protocol focuses on case finding and testing of those with impaired fasting glucose (IFG). The second section of the protocol focuses on coaching the individual person to adopt a healthy lifestyle. The practice nurse tries to get insight into the motivational situation of the participant. Based on this insight, three to four extra consultations spread over a one-year period are carried out. During these consultations the practice nurse gives advice and teaches concrete and applicable skills in order to increase the level of physical activity and healthy dietary habits. If necessary, participants are referred to a dietician, physiotherapist, lifestyle programs and/or local sports activities. After one year participants receive care as usual.

Control group
General practices assigned to the control group provide care as usual. This includes a yearly check on diabetes-related symptoms and blood glucose levels according the type 2 diabetes guideline of the Dutch College of General Practitioners.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in body mass index (BMI). Measurements were performed at baseline (T0) just after the diagnoses of IFG and before the start of the intervention, and after 1 (T1) and 2 (T2) years.

Secondary outcome measures

1. Waist circumference
2. Total and saturated fat intake
3. Physical activity
4. Systolic blood pressure
5. Blood glucose
6. Total cholesterol
7. Triglycerides
8. Behaviour determinants risk perception
9. Perceived knowledge, motivation, attitude, self efficacy and social norm

Anthropometric parameters and risk factors for developing diabetes were measured by a practice nurse. Biochemical parameters are determined in regional laboratories. Information about fat intake, physical activity, motivation and behaviour determinants were measured by questionnaires.

Overall trial start date

15/05/2010

Overall trial end date

30/10/2012

Reason abandoned

Eligibility

Participant inclusion criteria

All subjects diagnosed with IFG and motivated to change their lifestyle

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 people in each group (intervention and control)

Participant exclusion criteria

1. Subjects with emotional, psychological or intellectual problems that are likely to limit the ability of the individual to comply with the protocol
2. Malignant diseases
3. Other diseases or conditions associated with a poor prognosis

Recruitment start date

15/05/2010

Recruitment end date

30/10/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

Kennemerplein 7
Haarlem
2011 MH
Netherlands

Sponsor information

Organisation

Julius Center for Health Sciences and Primary Care (Netherlands)

Sponsor details

c/o Prof Guy EH Rutten
Huispost Str. 6.131
Utrecht
3508 GA
Netherlands
+31 (0)23 5310015
G.E.H.M.Rutten@umcutrecht.nl

Sponsor type

Hospital/treatment centre

Website

http://portal.juliuscentrum.nl

Funders

Funder type

Government

Funder name

Ministry of Health, Wellbeing and Sports (VWS) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Diabetes Federation (NDF) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/24295397
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26695176

Publication citations

  1. Protocol

    Hesselink AE, Bilo HJ, Jonkers R, Martens M, de Weerdt I, Rutten GE, A cluster-randomized controlled trial to study the effectiveness of a protocol-based lifestyle program to prevent type 2 diabetes in people with impaired fasting glucose., BMC Fam Pract, 2013, 14, 184, doi: 10.1186/1471-2296-14-184.

Additional files

Editorial Notes

14/01/2016: Publication reference added.