OverweightKIDSSTEPNCT03233425
Evaluation of Multiprofessional Group Programs for Paediatric Obesity Therapy
An observational study of Overweight, run by Ostschweizer Kinderspital at 1 site in Switzerland.
Trial summary
The aim of this pilot project is to disseminate multiprofessional group programs (*MGP*) for therapy of the estimated 119'140 overweight/obese children in Switzerland. Family-based behavioral MGPs have been implemented from 2009 to 2013 to determine changes of health and family behaviours, after the intensive phase… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Overweight
- What is being tested?
- multiprofessional group therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,152 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Mar 2014
- Phase
- Observational
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Overweight children < 18 years of age
Who may be able to join
- BMI above the 97th percentile, or in second line waist circumference or fat mass above the nor-mal range, or BMI above the 90th percentile associated with the presence of co-morbidities
- Medical examination is a pre-requisite
- Motivation of the patient and support by the family are pre-requisites
- Psychiatric diseases or severe psychosocial restraints must be adequately tackled.
- Informed consent of patients and parents to the participation in an anonymous evaluation,
Who cannot join
- healthy child
- no motivation for therapy, as assessed by interview and questionnaires to Patient and Family
- psychiatric disease without adequate treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Therapy for Overweight Children and Adolescents in Switzerland: Therapy in Multiprofessional Group Programs - Part 2, Collection and Analysis of Data
The aim of this pilot project is to disseminate multiprofessional group programs (*MGP*) for therapy of the estimated 119'140 overweight/obese children in Switzerland. Family-based behavioral MGPs have been implemented from 2009 to 2013 to determine changes of health and family behaviours, after the intensive phase (*T1*), at 1 and 2 years after start (*T2*, *T3*). MGP costs are reimbursed in Switzerland: 1) if 116 sessions are provided by experts in physical activity, nutrition and psychology; 2) if parents are included and if their adherence is higher than 85%. In the nationwide "Evaluation of Multiprofessional Group Programs for Paediatric Obesity Therapy" (*KIDSSTEP*) study, multiple psychosocial and physical parameters were assessed at T0, T2 and T3 . Out of 33 certified centers, 25 were active and only 19 were re-certified in 2013/2014. Obese children suffer from major co-morbidities and therefore, only one third of referred patients can be treated in MGPs and their beneficial effects on obesity as well as physical and mental health outcomes are sustained over 2 years.
Read the detailed description
In Switzerland, the number of overweight children <18 years is estimated to 80'000 and related cardiovascular, osteoarticular and other complications are already present in approximately in 50% of these youth. Controlled studies demonstrated that multiprofessional treatment programs can reduce adiposity and improve health risk factors. To pre-empt the deterioration of obesity and co-morbidities in adult life, the Swiss Department of the Interior (EDI) approved in 2007 the reimbursement of treatment of overweight children by health insurances , if conducted in certified multi-professional family-based group programs. All programs have to participate in a scientific evaluation study supported by the Federal Office of Public Health (FOPH) in order to determine nationwide outcomes in clinical practice. The goal of this study is to evaluate individual changes of physical activity, nutrition, behaviours, quality of life, co-morbidities and adiposity during therapy and to identify predictors of positive or negative changes.
During 5 years, the investigators will recruit about 200 children and adolescents aged 6 to 18 years every year. Patients must have a Body Mass Index (BMI), fat mass or waist circumference above the 97th percentile, or a BMI above the 90th percentile plus a co-morbidity. Together with their parents they will be enrolled in an intensive group therapy program for 6 to 12 months, with 12 months of follow up. To date, in 25 certified centres, physicians, nutrition and physical activity specialists as well as psychologists can provide a multiprofessional standardized care, the costs of participation being reimbursed after regular presence. At start, after 1 year and 2 years, standardized instruments validated in Swiss or European children will be used to document changes during therapy. Questionnaires will assess motivation, weight of parents, personal and family history, quality of life, child and family lifestyle, parenting skills, eating or psychological disorders, and satisfaction. Other investigations will include medical examination, blood tests, and European Fitness (*Eurofit*)-test for physical fitness and capacities. Anonymised data will be recorded centrally in an electronic database, after controlling for completeness and plausibility. Informed consent and positive votes of local ethical committees will be obtained. Reports on cross-sectional and longitudinal descriptive statistics and benchmarking will be provided once yearly. A comprehensive multivariate analysis of complex associations between predictors and health-related outcomes will be completed. Statistical analyses will be performed by specialists in each field and will be supervised by public health scientists. To guarantee meaningful analyses, the last patients will be included in December 2013.
- Conditions
- Overweight
- Being tested
- multiprofessional group therapy
- Keywords
- Child, adolescent, co-morbidity, psychology, motivation, physical activity, eating disorders, quality of life, therapy, predictors
- Medical subject headings
- Overweight, Motor Activity, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiprofessional group therapyBehavioural
Behavioural therapy of lifestyle including activity, family and eating habits
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index - standard deviation score (*SDS*), (*BMI-SDS*)
Age- and sex-adjusted BMI according to World Health Organisation (*WHO*) charts used in Switzerland
Measured: 2 years
Secondary outcomes (2)
Quality of life as assessed by Quality of life questionnaires for children and adolescents (*KIDSSCREEN*) with 52 questions
Outcome Measure is a Scale
Measured: 2 years
Eurofit - Test
Outcome measure is a score on physical fitness and sport activity of children and adolescents
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study startJan 2009
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostschweizer Kinderspital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, akj, Fachverband Adipositas im Kindes- und Jugendalter, Switzerland, Federal Office of Public Health, Switzerland
- Responsible party
- Principal investigator, Dagmar l'Allemand, Ostschweizer Kinderspital
- Investigators
- Dagmar lAllemand, Pr, Principal investigator, Ostschweizer Kinderspital, St. Gallen, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233425
- Sponsor's protocol ID
- EKSG 08/023
- Other IDs
- 09.004211/204.0001/-629, l'Allemand, 20110901
- Acronym
- KIDSSTEP
- Status last verified
- Jul 2017
- First submitted
- 4 Mar 2015
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Therapy for Overweight Children and Adolescents in Switzerland: Therapy in Multiprofessional Group Programs - Part 2, Collection and Analysis of Data
- ClinicalTrials.gov ID
- NCT03233425
- Acronym / sponsor ID
- KIDSSTEP / EKSG 08/023
- Conditions
- Overweight
- Keywords
- Child, adolescent, co-morbidity, psychology, motivation, physical activity, eating disorders, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,152 participants (actual)
- Lead sponsor
- Ostschweizer KinderspitalUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, akj, Fachverband Adipositas im Kindes- und Jugendalter, Switzerland, Federal Office of Public Health, Switzerland
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Jul 2017 (actual)
- 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.
The aim of this pilot project is to disseminate multiprofessional group programs (*MGP*) for therapy of the estimated 119'140 overweight/obese children in Switzerland. Family-based behavioral MGPs have been implemented from 2009 to 2013 to determine changes of health and family behaviours, after the intensive phase (*T1*), at 1 and 2 years after start (*T2*, *T3*). MGP costs are reimbursed in Switzerland: 1) if 116 sessions are provided by experts in physical activity, nutrition and psychology; 2) if parents are included and if their adherence is higher than 85%. In the nationwide "Evaluation of Multiprofessional Group Programs for Paediatric Obesity Therapy" (*KIDSSTEP*) study, multiple psychosocial and physical parameters were assessed at T0, T2 and T3 . Out of 33 certified centers, 25 were active and only 19 were re-certified in 2013/2014. Obese children suffer from major co-morbidities and therefore, only one third of referred patients can be treated in MGPs and their beneficial effects on obesity as well as physical and mental health outcomes are sustained over 2 years.
Detailed description
In Switzerland, the number of overweight children <18 years is estimated to 80'000 and related cardiovascular, osteoarticular and other complications are already present in approximately in 50% of these youth. Controlled studies demonstrated that multiprofessional treatment programs can reduce adiposity and improve health risk factors. To pre-empt the deterioration of obesity and co-morbidities in adult life, the Swiss Department of the Interior (EDI) approved in 2007 the reimbursement of treatment of overweight children by health insurances , if conducted in certified multi-professional family-based group programs. All programs have to participate in a scientific evaluation study supported by the Federal Office of Public Health (FOPH) in order to determine nationwide outcomes in clinical practice. The goal of this study is to evaluate individual changes of physical activity, nutrition, behaviours, quality of life, co-morbidities and adiposity during therapy and to identify predictors of positive or negative changes.
During 5 years, the investigators will recruit about 200 children and adolescents aged 6 to 18 years every year. Patients must have a Body Mass Index (BMI), fat mass or waist circumference above the 97th percentile, or a BMI above the 90th percentile plus a co-morbidity. Together with their parents they will be enrolled in an intensive group therapy program for 6 to 12 months, with 12 months of follow up. To date, in 25 certified centres, physicians, nutrition and physical activity specialists as well as psychologists can provide a multiprofessional standardized care, the costs of participation being reimbursed after regular presence. At start, after 1 year and 2 years, standardized instruments validated in Swiss or European children will be used to document changes during therapy. Questionnaires will assess motivation, weight of parents, personal and family history, quality of life, child and family lifestyle, parenting skills, eating or psychological disorders, and satisfaction. Other investigations will include medical examination, blood tests, and European Fitness (*Eurofit*)-test for physical fitness and capacities. Anonymised data will be recorded centrally in an electronic database, after controlling for completeness and plausibility. Informed consent and positive votes of local ethical committees will be obtained. Reports on cross-sectional and longitudinal descriptive statistics and benchmarking will be provided once yearly. A comprehensive multivariate analysis of complex associations between predictors and health-related outcomes will be completed. Statistical analyses will be performed by specialists in each field and will be supervised by public health scientists. To guarantee meaningful analyses, the last patients will be included in December 2013.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Overweight children < 18 years of age
Key inclusion criteria (5 listed)
- BMI above the 97th percentile, or in second line waist circumference or fat mass above the nor-mal range, or BMI above the 90th percentile associated with the presence of co-morbidities
- Medical examination is a pre-requisite
- Motivation of the patient and support by the family are pre-requisites
- Psychiatric diseases or severe psychosocial restraints must be adequately tackled.
- Informed consent of patients and parents to the participation in an anonymous evaluation,
Key exclusion criteria (3 listed)
- healthy child
- no motivation for therapy, as assessed by interview and questionnaires to Patient and Family
- psychiatric disease without adequate treatment
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 |
|---|---|---|
| multiprofessional group therapyBehavioural therapy of lifestyle including activity, family and eating habits | Behavioural | – |
Primary outcome
Body mass index - standard deviation score (*SDS*), (*BMI-SDS*)
Time frame: 2 years
Age- and sex-adjusted BMI according to World Health Organisation (*WHO*) charts used in Switzerland
2 secondary outcomes
Quality of life as assessed by Quality of life questionnaires for children and adolescents (*KIDSSCREEN*) with 52 questions
Time frame: 2 years
Eurofit - Test
Time frame: 2 years
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 28 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Dagmar lAllemand, Pr principal investigator
Ostschweizer Kinderspital, St. Gallen, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight, run by Ostschweizer Kinderspital at 1 site in Switzerland.
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 5 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 28 Jul 2017. 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 Switzerland. 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?
Body mass index - standard deviation score (*SDS*), (*BMI-SDS*) (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 28 Jul 2017.