Weight Loss Clinical Trial
Official title:
Lifestyle Related Health and Health Promoting Activities for Youths With Intellectual Disabilities
Verified date | February 2011 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
A whole of school intervention with daily physical activity and healthy food for students with intellectual disabilities. The aim is to provide plenty of concrete examples of healthy life style choices and using school personnel and peers as role models. This will presumably result in healthier weight, better fitness and not least in new familiar healthy habits.
Status | Completed |
Enrollment | 145 |
Est. completion date | June 2010 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 22 Years |
Eligibility |
Inclusion Criteria: - mild/moderate intellectual disability - students at the upper secondary schools for intellectual disability students Exclusion Criteria: - severe intellectual disability - obesity related syndromes - major physical disabilities |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet, Department of clinical science, intervention and technology. Division of pediatrics, B62 | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | City of Stockholm Competence Fund, Health Care Sciences Postgraduate School at the Karolinska Institutet, Lindeparkens upper secondary school for intellectual disability students, Mälardalen University, Stockholm County Council, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease in cardio metabolic risk factors | At baseline and after 2 years of intervention; height, weight, waist circumference, blood pressure was measured. In addition fasting blood samples of total cholesterol, triglycerides, fasting glucose and insulin. Absorptiometry photos (DXA) for body composition. Postintervention measures in addition compared to a controlgroup. Cross sectional data on all school students of all above mentioned variables and also cholesterol as HDL and LDL compared to a control group. |
2 years | No |
Secondary | Increase in physical fitness | At baseline and after 2 years of intervention a submaximal ergometer bicycle test. Postintervention measures in addition compared to a controlgroup. Cross sectional data on all school students from accelerometer, actiwatch, for frequency, intensity and level of physical activity compared to a control group. |
2 years | No |
Secondary | Increased vegetable intake | To measure if the special plate made students take 37,5% vegetables or more as is the vegetable field on the plate.Effect of the specially designed plate according the plate-model evaluates in an observational study with videorecording and photos of a self served lunchportion on an ordinary plate in an experimental situation. | at least 1 year | No |
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