Weight LossNCT01291238
School Intervention With Daily Physical Activity and Healthy Food for Students With an Intellectual Disability.
A study testing Healthier, Smarter, Happier in people with Weight Loss and Food Habits, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 16 to 22 years
- Conditions the study is for
- Weight Loss, Food Habits, Mental Retardation
- What is being tested?
- Healthier, Smarter, Happier
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2004to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- mild/moderate intellectual disability
- students at the upper secondary schools for intellectual disability students
Who cannot join
- severe intellectual disability
- obesity related syndromes
- major physical disabilities
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of clinical science, intervention and technology. Division of pediatrics, B62
Stockholm, SE-141 86
About this study
Official title: Lifestyle Related Health and Health Promoting Activities for Youths With Intellectual Disabilities
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.
Read the 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.
- Conditions
- Weight Loss, Food Habits, Mental Retardation
- Being tested
- Healthier, Smarter, Happier
- Keywords
- learning disability, blood lipids, cardio metabolic risk factors, upper secondary school for learning disability students, adolescents, cardio respiratory fitness, absorptiometry photos
- Medical subject headings
- Weight Loss, Feeding Behavior, Intellectual Disability, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthier, Smarter, HappierBehavioural
Increased physical activity and decreased sugar and fat intake during school hours
| Study group | Role | What they receive |
|---|---|---|
| Healthy lifestyle habits | Experimental | Increased physical activity and healthy food with decreased sugar and fat content Receives: Behavioral: Healthier, Smarter, Happier |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 2 years
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.
Measured: at least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startMar 2004
- Primary completionJun 2007
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Claude Marcus, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291238
- Sponsor's protocol ID
- 2009/772-32
- Status last verified
- Feb 2011
- First submitted
- 7 Feb 2011
- Last updated
- 8 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Related Health and Health Promoting Activities for Youths With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT01291238
- Acronym / sponsor ID
- 2009/772-32
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- 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
- Study start
- Mar 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy lifestyle habits | Experimental | Behavioral: Healthier, Smarter, HappierIncreased physical activity and healthy food with decreased sugar and fat content |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- mild/moderate intellectual disability
- students at the upper secondary schools for intellectual disability students
Key exclusion criteria (3 listed)
- severe intellectual disability
- obesity related syndromes
- major physical disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthier, Smarter, HappierIncreased physical activity and decreased sugar and fat intake during school hours | Behavioural | Healthy lifestyle habits |
Primary outcome
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.
2 secondary outcomes
Increase in physical fitness
Time frame: 2 years
Increased vegetable intake
Time frame: at least 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Marcus, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthier, Smarter, Happier in people with Weight Loss and Food Habits, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in cardio metabolic risk factors (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2011.