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School Intervention With Daily Physical Activity and Healthy Food for Students With an Intellectual Disability.

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ClinicalTrials.gov Identifier: NCT01291238
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : February 8, 2011
Information provided by:

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.

Condition or disease Intervention/treatment
Weight Loss Food Habits Mental Retardation Behavioral: Healthier, Smarter, Happier

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Lifestyle Related Health and Health Promoting Activities for Youths With Intellectual Disabilities
Study Start Date : March 2004
Primary Completion Date : June 2007
Study Completion Date : June 2010

Arms and Interventions

Arm Intervention/treatment
Experimental: Healthy lifestyle habits
Increased physical activity and healthy food with decreased sugar and fat content
Behavioral: Healthier, Smarter, Happier
Increased physical activity and decreased sugar and fat intake during school hours

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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. 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.

Eligibility Criteria

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Ages Eligible for Study:   16 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291238

Karolinska Institutet, Department of clinical science, intervention and technology. Division of pediatrics, B62
Stockholm, Sweden, SE-141 86
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
City of Stockholm Competence Fund
Lindeparkens upper secondary school for intellectual disability students
Mälardalen University
Health Care Sciences Postgraduate School at the Karolinska Institutet
Principal Investigator: Claude Marcus, Professor Karolinska Institutet
More Information

Responsible Party: Claude Marcus, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01291238     History of Changes
Other Study ID Numbers: 2009/772-32
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: February 8, 2011
Last Verified: February 2011

Keywords provided by Karolinska Institutet:
learning disability
blood lipids
cardio metabolic risk factors
upper secondary school for learning disability students
cardio respiratory fitness
absorptiometry photos

Additional relevant MeSH terms:
Weight Loss
Intellectual Disability
Body Weight Changes
Body Weight
Signs and Symptoms
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders