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ID
Source
Brief title
Health condition
Population screening
Type 2 diabetes
Lifestyle intervention
Prevention
Populatie screening
Type 2 diabetes
Leefstijlinterventie
Preventie
Sponsors and support
Professor of Social Medicine
Dept. of Social Medicine
Academic Medical Centre, University of Amsterdam
Intervention
Outcome measures
Primary outcome
1. Normal blood glucose values;
2. Prediabetes (impaired fasting glucose and impaired glucose tolerance);
3. Diabetes.
Secondary outcome
1. Views on the screening;
2. Views on the intervention.
Background summary
Background
Type 2 diabetes mellitus (DM) is highly prevalent among the Hindustani Surinamese; 30% in the group 45-60 years. This group is not only younger at presentation, but also at high risk of developing CVD. Early detection and treatment of DM may decrease the risk of complications. The objective of this study is to develop a screening program and lifestyle intervention for Hindustani Surinamese, aimed at identifying pre-diabetes and preventing DM.
Methods
Screening: 1500 Hindustani Surinamese in The Hague, aged 18 to 60 years, will be randomized to a standard or intensive recruitment strategy. Participants will be asked to donate a fasting blood sample and an oral glucose tolerance test will be carried out.
Intervention: Persons found to have 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 to participate in the intervention; they will be randomized to the lifestyle intervention or control group.
The content of the intervention is based on previous lifestyle interventions and will be targeted to the Hindustani Surinamese. Data on physical activity and dietary habits in the Hindustani Surinamese population are available from the SUNSET-study. A process evaluation among Surinamese participants in a physical exercise programme will provide insight into determinants of physical activity. Additional focus group discussions will take place among Hindustani Surinamese to gain further insight in determinants of physical activity and healthy dietary habits.
Results
The full design of the screening will be presented. Moreover, we will discuss the content of the the lifestyle intervention, including the results of the SUNSET data and the focus group discussions.
Conclusion
If the screening and lifestyle intervention are found to be feasible, a larger intervention study will be set up in order to determine the effectiveness of the screening followed by the intervention.
Study objective
A systematic screening and a lifestyle-intervention for pre-diabetes targeted at the Hindustani Surinamese population will prevent or postpone the onset of diabetes mellitus type 2.
Study design
-
Intervention
Lifestyle intervention, which consists of dietary counseling and supervised physical activity.
Academic Medical Centre, University of Amsterdam
PO-box 22660
Wietske Hoekstra
Amsterdam 1100 DD
The Netherlands
+31 20 5667441
w.hoekstra@amc.uva.nl
Academic Medical Centre, University of Amsterdam
PO-box 22660
Wietske Hoekstra
Amsterdam 1100 DD
The Netherlands
+31 20 5667441
w.hoekstra@amc.uva.nl
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.
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. Participation in a regular vigorous exercise and/or diet program.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL1019 |
| NTR-old | NTR1050 |
| Other | Zonmw : 6130.0034 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |