|- candidate number||4257|
|- NTR Number||NTR1499|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-okt-2008|
|- Secondary IDs||NTR1050 |
|- Public Title||Diabetes prevention study in Hindustani Surinamese|
|- Scientific Title||The effectiveness of a targeted diabetes prevention programme for Hindustani Surinamese, consisting
of screening followed by a lifestyle intervention
|- hypothesis||A systematic screening and a lifestyle-intervention targeted at 18-60 year old Hindustani Surinamese men and women with pre-diabetes will prevent or postpone the onset of diabetes mellitus type 2.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Prevention, Impaired glucose tolerance (IGT) , Impaired fasting glucose (IFG)|
|- Inclusion criteria||Inclusion criteria screening: |
1. Hindustani Surinamese background;
2. Aged between 18-60 years.
Inclusion criteria intervention:
1. Hindustani Surinamese background;
2. Aged between 18-60 years;
3. Persons found to have prediabetes during the screening.
|- Exclusion criteria||Exclusion criteria screening:|
1. Known diabetes patients;
2. Pregnant women.
Exclusion criteria intervention:
1. Persons found to have diabetes during the screening;
2. Any chronic illness that makes participation during lifestyle-intervention impossible;
3. Medication known to interfere with glucose tolerance;
4. Current participation in a vigorous exercise and/or dietary intervention.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2008|
|- planned closingdate||1-dec-2012|
|- Target number of participants||500|
|- Interventions||Lifestyle intervention, which consists of dietary counselling and supervised physical activity.|
|- Primary outcome||- Normal blood glucose values; |
- Prediabetes (impaired fasting glucose and impaired glucose tolerance determined through OGTT);
- Incident diabetes mellitus.
|- Secondary outcome||- Plasma glucose levels;|
- Blood pressure levels;
- Lipid profile;
- Heart rate;
- Physical activity;
- Cost and benefits.
|- Timepoints||After initial screening:|
Baseline, 12 months and 36 months
|- Trial web site||http://www.amc.nl/dhiaan|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| E.M.A. Vlaar|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. K. Stronks|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Social Medicine|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Vlaar et al. BMC Public Health 2012, 12:371 (doi:10.1186/1471-2458-12-371.|
|- Brief summary||Background:|
Type 2 diabetes mellitus (DM) is highly prevalent among the Hindustani Surinamese. This group is not only younger at presentation, but also at high risk of developing CVD. Early detection and an intensive lifestyle intervention may prevent or postpone the onset of DM.
The objective of this study is to evaluate the effectiveness of a targeted diabetes prevention programme for Hindustani Surinamese, consisting of screening followed by a lifestyle intervention.
Screening: 6000 Hindustani Surinamese in The Hague, aged 18 to 60 years will be recruited by an intensive recruitment strategy which was developed and evaluated during the pilot phase of the project. The strategy consists of a combination of written information and personal contact.
Participants will be asked to donate a fasting blood sample and an oral glucose tolerance test will be carried out.
Persons found to DM will be referred to their own physician for further diagnostics and treatment conform the guidelines of the Dutch College of General Practitioners.
Persons with suspected impaired fasting glucose (fasting plasma glucose 5.6-< 7.0mmol/l) or impaired glucose tolerance (2-hour post-load glucose ¡Ý7.8-<11.1mmol/l) will be invited for a confirmatory test.
Persons with confirmed IFG or IGT will be invited to participate in the intervention trial;
Participants in the trial will be randomly assigned to the lifestyle intervention or control group.
The lifestyle intervention was developed during the pilot phase of the project and consists of dietary counselling and a supervised physical activity. The aim of the dietary intervention is to change the diet according to the current dietary guidelines. A combination of Motivational Interviewing (MI) and the Transtheoretical Model will be used as counselling method and is tailored to the Hindustani population. The supervised physical activity consists of an “Exercise on prescription” program (EOP, in Dutch: “Bewegen op recept”/BOR) of the STIOM. The main focus of this programme is on increasing participation of the client, providing tailored activities and increasing motivation through personal coaching.
The effectiveness of the lifestyle intervention in preventing incident cases of DM and with regard to secondary outcomes (e.g. plasma glucose levels, blood pressure levels, lipid profile, microalbuminuria, heart rate and weight) will be determined. Also the intermediate outcomes (e.g. motivation, diet, physical activity) during and after the programme, the cost and benefits of the prevention program and the potential side-effects will be determined.
If the screening and lifestyle intervention are found to be (cost) effective, methods for implementation of this programme will be suggested.
|- Main changes (audit trail)||The full protocol, including changes to the original protocol, were reported in Vlaar et al. (doi:10.1186/1471-2458-12-371). All changes were approved by the MEC.|
|- RECORD||28-okt-2008 - 22-sep-2012|