School Intervention With Daily Physical Activity and Healthy Food for Students With an Intellectual Disability.
Primary Purpose
Weight Loss, Food Habits, Mental Retardation
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Healthier, Smarter, Happier
Sponsored by
About this trial
This is an interventional prevention trial for Weight Loss focused on measuring learning disability, blood lipids, cardio metabolic risk factors, upper secondary school for learning disability students, adolescents, cardio respiratory fitness, absorptiometry photos
Eligibility Criteria
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
Sites / Locations
- Karolinska Institutet, Department of clinical science, intervention and technology. Division of pediatrics, B62
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy lifestyle habits
Arm Description
Increased physical activity and healthy food with decreased sugar and fat content
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01291238
First Posted
February 7, 2011
Last Updated
February 7, 2011
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, City of Stockholm Competence Fund, Lindeparkens upper secondary school for intellectual disability students, Mälardalen University, Health Care Sciences Postgraduate School at the Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT01291238
Brief Title
School Intervention With Daily Physical Activity and Healthy Food for Students With an Intellectual Disability.
Official Title
Lifestyle Related Health and Health Promoting Activities for Youths With Intellectual Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, City of Stockholm Competence Fund, Lindeparkens upper secondary school for intellectual disability students, Mälardalen University, Health Care Sciences Postgraduate School at the Karolinska Institutet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Food Habits, Mental Retardation
Keywords
learning disability, blood lipids, cardio metabolic risk factors, upper secondary school for learning disability students, adolescents, cardio respiratory fitness, absorptiometry photos
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy lifestyle habits
Arm Type
Experimental
Arm Description
Increased physical activity and healthy food with decreased sugar and fat content
Intervention Type
Behavioral
Intervention Name(s)
Healthier, Smarter, Happier
Intervention Description
Increased physical activity and decreased sugar and fat intake during school hours
Primary Outcome Measure Information:
Title
Decrease in cardio metabolic risk factors
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Increase in physical fitness
Description
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.
Time Frame
2 years
Title
Increased vegetable intake
Description
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.
Time Frame
at least 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Marcus, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet, Department of clinical science, intervention and technology. Division of pediatrics, B62
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
School Intervention With Daily Physical Activity and Healthy Food for Students With an Intellectual Disability.
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