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

Weight Loss Clinical Trial

Official title:

Lifestyle Related Health and Health Promoting Activities for Youths With Intellectual Disabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291238
• Other study ID #: 2009/772-32
• Status: Completed
• Phase: N/A
• First received: February 7, 2011
• Last updated: February 7, 2011
• Start date: March 2004
• Est. completion date: June 2010

Study information

• Verified date: February 2011
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Food Habits
• Intellectual Disability
• Mental Retardation
• Weight Loss

Intervention

Behavioral:
• Healthier, Smarter, Happier
Increased physical activity and decreased sugar and fat intake during school hours

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Department of clinical science, intervention and technology. Division of pediatrics, B62	Stockholm

Sponsors (6)

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

Country where clinical trial is conducted

Sweden, 

Outcome

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