- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01291238
School Intervention With Daily Physical Activity and Healthy Food for Students With an Intellectual Disability.
Lifestyle Related Health and Health Promoting Activities for Youths With Intellectual Disabilities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Youth with an intellectual disability are reported more sedentary and more often overweight than non intellectual disability youth. Cardio metabolic risk factors are observed more frequent and at an earlier age among young people with intellectual disability. The school reaches all students and they spend the main part of their day in the school milieu hence examples of healthy lifestyle can be provided there.
This intervention increased physical activity with daily scheduled physical activity. At least one lesson each week was at the gym. Food provided in the school environment was considered from content of sugar and fat and ónly healthy food choices was available at school. This included all school activities, both in the school area and on school activities out in the community. It included home economic lessons as well as the school cafeterias supply and school lunch content.
To increase vegetable intake a special designed plate was used for lunch according the "plate model". In addition, the plate model was one theme during art class.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden, SE-141 86
- Karolinska Institutet, Department of clinical science, intervention and technology. Division of pediatrics, B62
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy lifestyle habits
Increased physical activity and healthy food with decreased sugar and fat content
|
Increased physical activity and decreased sugar and fat intake during school hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decrease in cardio metabolic risk factors
Time Frame: 2 years
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increase in physical fitness
Time Frame: 2 years
|
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
|
|
Increased vegetable intake
Time Frame: at least 1 year
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009/772-32
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