The first objective of this study is to develop a screening program for the Hindustani Surinamese population and to test its feasibility. The second objective is to develop a lifestyle intervention aimed at preventing DM, targeted to the Hindustani…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Screening:
- Normal blood glucose values
- Prediabetes (impaired fasting glucose and impaired glucose tolerance)
- Diabetes
Secondary outcome
Views on the screening (from participants and professionals)
Views on the intervention (from participants and professionals)
Background summary
Diabetes mellitus type 2 (DM) is a commonly occurring chronic condition, that
is particularly prevalent among certain ethnic minorities. For example, the
prevalence of DM among Hindustani Surinamese is 40% among the age group 45-60
years. In addition, the Hindustani Surinamese appear to already have a higher
prevalence of DM at young age (20% in the age group 35-45 years). Moreover, the
Hindustani have a higher risk of developing cardiovascular disease, while early
detection, e.g. by screening, and adequate treatment of DM may decrease the
risk of these complications such as cardiovascular disease.
Previous studies have shown that the period between onset of DM and diagnosis
of DM is on average 10 years. Lifestyle intervention programs have been shown
to be effective in delaying or preventing DM with impaired glucose tolerance.
However, the effectiveness of these interventions has just been assessed among
(elderly) white populations. Given the different risk profile of the Hindustani
Surinamese population and differences in the lifestyle, it is to be expected
that existing programs have to be adjusted to suit the needs of that
population.
Study objective
The first objective of this study is to develop a screening program for the
Hindustani Surinamese population and to test its feasibility. The second
objective is to develop a lifestyle intervention aimed at preventing DM,
targeted to the Hindustani Surinamese population.
In addition, the feasibility of this intervention will be assessed. 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 lifestyle intervention.
Study design
We will invite a randomly selected group of 1500 18 to 60 year old Hindustani
Surinamese patients, registered in general practices in The Hague, for the
study. Before recruitment, potential participants will be randomly allocated to
a strandard or intensive recruitment strategy. Data collection consists of a
brief questionnaire followed by a physical examination (weight, length, waist
circumference, blood pressure, fasting plasma glucose). In addition, an oral
glucose tolerance test will be carried out.
Participants with impaired glucose tolerance or impaired fasting glucose will
subsequently be invited to participate in the intervention. Those who provide
informed consent will be randomly assigned to the lifestyle intervention group
or the control group. The measurement for this study consists of a confirmatory
OGTT and an interview.
Intervention
Participants in the intervention group will be offered a lifestyle
intervention. The intended content of the intervention is:
- Participation in a physical exercise programme *Bewegen op Recept* : 20
sessions of supervised physical activity.
- Dietary counselling: individual 3-monthly dietary counseling by a trained
dietician of Hindustani Surinamese origin.
The control group will receive generic lifestyle advice concerning physical
activity, dietary habits and prevention of overweight.
Study burden and risks
not applicable
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria screening
- Hindustani Surinamese background
- Aged between 18-60 years;Inclusion criteria intervention:
- Hindustani Surinamese background
- Aged between 18-60 years
- Persons found to have prediabetes during the screening
-
Exclusion criteria
Exclusion criteria screening:
- Known diabetes patients;Exclusion criteria intervention:
- Persons found to have diabetes during the screening
- Any chronic illness that makes participation in a lifestyle-intervention impossible
- Medication known to interfere with glucose tolerance
- Participation in a regular vigorous exercise and/or diet program
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL17628.018.07 |