|- candidate number||14033|
|- NTR Number||NTR3721|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-nov-2012|
|- Secondary IDs||209.20.021 LekkerLangLeven|
|- Public Title||Lifestyle intervention for individuals with low socioeconomic status from different ethnic origins.|
|- Scientific Title||Tailoring an existing lifestyle intervention to reduce waist circumference and improve other components of the metabolic syndrome in individuals with low SES from different ethnic origins.|
|- Healt Condition(s) or Problem(s) studied||Metabolic syndrome, Elevated waist circumference|
|- Inclusion criteria||1. Age 30-70 years;|
2. Low socioeconomic status;
3. Dutch, Turkish or Moroccan ethnicity;
4. Waist-to-height ratio greater than 0.5;
5. Sufficient fluency in speaking the Dutch language to be able to follow the lifestyle intervention program.
|- Exclusion criteria||1. Treatment for known hypertension, hypercholesterolemia, diabetes mellitus type 2, cardiovascular diseases and/or chronic renal failure (medication use);|
2. High value for systolic blood pressure, diastolic blood pressure, fasting glucose, triglycerides, total or LDL cholesterol;
3. Any mental or physical disability that will hinder participation in the lifestyle intervention;
4. Participation in another regular vigorous exercise and/or diet programme targeting weight loss;
5. Pregnant or lactating.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||14-jan-2013|
|- planned closingdate||14-jan-2015|
|- Target number of participants||252|
|- Interventions||The intervention consists of a nutrition and physical activity component. The nutrition component of the lifestyle intervention consists of four hours individually tailored dietary advice and three times dietary advice in groups. The advice is given by a dietician from the same ethnic origin as the participant(s). The physical activity part consists of weekly participation in a physical activity programme. The programme is offered in the neighbourhood of the participants. The lifestyle intervention has a duration of 12 months.|
|- Primary outcome||Change in waist circumference.|
|- Secondary outcome||Prevalence of metabolic syndrome and change in values of other components of the metabolic syndrome (fasting triglycerides, HDL cholesterol and glucose, and blood pressure).|
|- Timepoints||Baseline and after 12 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. D. Teuscher|
|- CONTACT for SCIENTIFIC QUERIES||Msc. A.J. Bukman|
|- Sponsor/Initiator ||Wageningen University (WUR), University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|Dutch Diabetes Foundation, Netherlands Heart Foundation (NHS, Nederlandse Hartstichting), Dutch Kidney Foundation (Nierstichting Nederland)|
|- Brief summary||Rationale: |
Individuals with low socioeconomic status (SES) and some ethnic minorities show increased risk for type 2 diabetes mellitus and cardiovascular diseases. However, only few lifestyle interventions have been specifically directed to these high risk groups. The effects of the SLIM lifestyle program were promising in reducing the incidence of type 2 diabetes mellitus in individuals with impaired glucose tolerance. However the relatively high dropout among low SES subjects asks for adaptation of the program to make it more suitable for low SES subjects.
To evaluate the effectiveness of a tailored version of the SLIM lifestyle program to reduce waist circumference and improve other components of the metabolic syndrome in individuals with a low socioeconomic status from different ethnic origins.
For this quasi-experimental intervention study, a parallel design will be used: 252 low SES subjects with elevated waist circumference will be allocated to either the intervention group or control group. The total duration of the study will encompass about two years; the intervention itself will have a duration of 12 months. Before (= baseline) and after the intervention several health-related measurements will be performed.
The study population consists of 252 low SES individuals (30-70y) from Dutch, Moroccan or Turkish origin with an elevated waist circumference.
The intervention group will participate in a combined lifestyle intervention that consists of a nutrition and physical activity component. The nutrition component of the combined lifestyle intervention consists of four hours individually tailored dietary advice and three times dietary advice in groups, preferably given by a dietician from the same ethnic origin as the subject(s). The physical activity part consists of weekly participation in a physical activity programme. The programme is offered in the neighbourhood of the participants. Subjects in the control group will receive a minimal intervention at the start of the study consisting of one group meeting where they receive general lifestyle advice, information about their own results of the health-related measurements performed at baseline and written information about the beneficial effects of a healthy diet and physical activity. No individual advice or programmes are provided to the control group.
Main study parameters:
The primary outcome is change in waist circumference. Secondary outcomes are prevalence of metabolic syndrome and changes in values of other components of the metabolic syndrome (fasting triglycerides, HDL cholesterol and glucose, and blood pressure).
|- Main changes (audit trail)|
|- RECORD||27-nov-2012 - 19-dec-2012|