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

This study has been completed.
Sponsor:
Collaborators:
Stockholm County Council, Sweden
City of Stockholm Competence Fund
Lindeparkens upper secondary school for intellectual disability students
Malardalen University
Health Care Sciences Postgraduate School at the Karolinska Institutet
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01291238
First received: February 7, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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 Intervention
Weight Loss
Food Habits
Mental Retardation
Behavioral: Healthier, Smarter, Happier

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Lifestyle Related Health and Health Promoting Activities for Youths With Intellectual Disabilities

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Decrease in cardio metabolic risk factors [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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 [ Time Frame: at least 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 145
Study Start Date: March 2004
Study Completion Date: June 2010
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291238

Locations
Sweden
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
Malardalen University
Health Care Sciences Postgraduate School at the Karolinska Institutet
Investigators
Principal Investigator: Claude Marcus, Professor Karolinska Institutet
  More Information

No publications provided

Responsible Party: Claude Marcus, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01291238     History of Changes
Other Study ID Numbers: 2009/772-32
Study First Received: February 7, 2011
Last Updated: February 7, 2011
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014