Effectiveness of a protocol-based lifestyle program to prevent type 2 diabetes
| ISRCTN | ISRCTN41209683 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41209683 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/10/2013
- Registration date
- 30/10/2013
- Last edited
- 14/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Kennemerplein 7
Haarlem
2011 MH
Netherlands
| Phone | +31 (0)23 5310015 |
|---|---|
| A.Hesselink@rescon.nl |
Study information
| Study design | Cluster randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Medical Ethics Committee Isala Klinieken, METC number: NL31342.075.10 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/05/2010 |
| Completion date | 30/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 people in each group (intervention and control) |
| Key inclusion criteria | All subjects diagnosed with IFG and motivated to change their lifestyle |
| Key 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 |
| Date of first enrolment | 15/05/2010 |
| Date of final enrolment | 30/10/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
2011 MH
Netherlands
Sponsor information
Hospital/treatment centre
c/o Prof Guy EH Rutten
Huispost Str. 6.131
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)23 5310015 |
|---|---|
| G.E.H.M.Rutten@umcutrecht.nl | |
| Website | http://portal.juliuscentrum.nl |
"ROR" |
https://ror.org/0575yy874 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 02/12/2013 | Yes | No | |
| Results article | results | 22/12/2015 | Yes | No |
Editorial Notes
14/01/2016: Publication reference added.
