NCT01291238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2011

Completed
Last Updated

February 8, 2011

Status Verified

February 1, 2011

Enrollment Period

3.3 years

First QC Date

February 7, 2011

Last Update Submit

February 7, 2011

Conditions

Keywords

learning disabilityblood lipidscardio metabolic risk factorsupper secondary school for learning disability studentsadolescentscardio respiratory fitnessabsorptiometry photos

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Increase in physical fitness

    2 years

  • Increased vegetable intake

    at least 1 year

Study Arms (1)

Healthy lifestyle habits

EXPERIMENTAL

Increased physical activity and healthy food with decreased sugar and fat content

Behavioral: Healthier, Smarter, Happier

Interventions

Increased physical activity and decreased sugar and fat intake during school hours

Healthy lifestyle habits

Eligibility Criteria

Age16 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • mild/moderate intellectual disability
  • students at the upper secondary schools for intellectual disability students

You may not qualify if:

  • severe intellectual disability
  • obesity related syndromes
  • major physical disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet, Department of clinical science, intervention and technology. Division of pediatrics, B62

Stockholm, SE-141 86, Sweden

Location

MeSH Terms

Conditions

Weight LossFeeding BehaviorIntellectual DisabilityLearning Disabilities

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesNeurodevelopmental DisordersMental DisordersCommunication Disorders

Study Officials

  • Claude Marcus, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2011

First Posted

February 8, 2011

Study Start

March 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2010

Last Updated

February 8, 2011

Record last verified: 2011-02

Locations