Obesity, ChildhoodNCT05424094
HRQoL in Overweight and Obese Children/Adolescents
A study testing multi-professional group programme 'kinderleicht' in people with Obesity, Childhood and Health Related Quality of Life, run by Frank Wieber.
Trial summary
The primary aim of the present study is to record changes in the health-related quality of life (HRQoL) of children/adolescents participating in the multi-professional group programme 'kinderleicht' in 2022 over the course of the eleven-month active phase. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Obesity, Childhood, Health Related Quality of Life, Intervention Program
- What is being tested?
- multi-professional group programme 'kinderleicht'
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 30 Sep 2023
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- girls/boys aged 7-17 years.
- participation with children
- age-adjusted BMI: P > 97th percentile or 90th-97th percentile + diseases whose prognosis is worsened by the overweight or are the result of the overweight
- medical examination unobjectionable
- motivation to participate in the programme is given
- written informed consent of the participant, 6.1. for children up to 14 years of age, verbal consent of the child is sufficient, plus written consent of the parents or a legal representative 6.2. for adolescents aged 14 and over, written consent from the adolescent is sufficient.
Who cannot join
- BMI < 90 percentile
- not part of 'easy for children
- medical examination questionable
- no motivation to participate in the programme
- no verbal and/or written consent of the children and their parents/legal representatives
About this study
Official title: Health-related Quality of Life in Overweight and Obese Children/Adolescents - a Pilot Project in the 'Kinderleicht' Group Programme
The primary aim of the present study is to record changes in the health-related quality of life (HRQoL) of children/adolescents participating in the multi-professional group programme 'kinderleicht' in 2022 over the course of the eleven-month active phase. In addition, these data will be examined for correlation with changes in BMI, waist and hip circumference, and motor performance.
Secondarily, the study addresses the questions of whether the recording of HROoL by means of the KINDL questionnaire is practicable for the programme leaders and what benefit can be gained from the analysed data for future cohorts.
Read the detailed description
According to the 2021 publication of the WHO European Childhood Obesity Surveillance Initiative (COSI), overweight and obesity in children and adolescents remains one of the most serious health problems facing the European population in the 21st century. The WHO responded to this problem in 2019 with a review paper on the propagated intervention approaches. With its developed national guidelines, Switzerland relies on multiprofessional group programmes. One of the eleven currently tested and certified programmes is 'kinderleicht' in Chur. The nationwide KIDSSTEP study from 2014 - on which the nationwide guidelines for multiprofessional group programmes are based - shows that it is imperative to record the health-related quality of life (HRQoL) of the children and adolescents as well as their families. In practice, however, this evidence is still too little implemented. Using the example of 'kinderleicht', it is to show that the recording and documentation of HRQoL is practicable and can provide valuable insights for both programme participants and programme managers. The primary goal is to record the health-related quality of life of children and adolescents participating in the multi-professional group programme 'kinderleicht' in 2022 over the course of the eleven-month active phase. At the same time, these data are to be correlated and interpreted with changes in BMI, waist and hip circumference and motor performance. Secondarily, possible sensitive/difficult phases of a participant during the active phase of the intervention will be identified in order to provide the best possible coaching to the families of future cohorts.
- Conditions
- Obesity, Childhood, Health Related Quality of Life, Intervention Program, Obesity, Adolescent, Overweight and Obesity
- Being tested
- multi-professional group programme 'kinderleicht'
- Keywords
- obesity, overweight, health related quality of life
- Medical subject headings
- Pediatric Obesity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-professional group programme 'kinderleicht'Behavioural
12-16 children/adolescents who participate in the multi-professional group programme 'kinderleicht' receive coaching in the areas of behaviour, exercise, nutrition and medicine from qualified professionals on fridays during 11 months.
| Study group | Role | What they receive |
|---|---|---|
| 'kinderleicht' programme | Experimental | Children receive coaching in the areas of behaviour, exercise, nutrition and medicine from qualified professionals. Receives: Behavioral: multi-professional group programme 'kinderleicht' |
What is being measured
The primary outcome is the main question the study is designed to answer.
health related quality of life (HRQoL) over 11 months
measured with the 'KINDL'-questionair; linkert scaled with a maximum value of 100 and a minimum value of 0 (points); the higher the score the better
Measured: 11 months
Secondary outcomes (3)
Rate of Body Mass Index (BMI) over 11 months
weight (kilograms) and height (meters) will be combined to report the BMI rate in kg/m^2; the BMI rate is age-appropriate for children and adolescents; the aim of the intervention programme is to reduce the BMI rate in obese children so a lower BMI rate is better than a higher one
Measured: 11 months
hip-waist ratio
hip and waist circumference in centimetres are combined to hip-waist ratio
Measured: 11 months
motor performance
motor performance ist measured in seven categories by test DKT-Fitnessolympiade; Results are graded according to the German school grading system; minimum grade 6 and maximum grade 1; the lower the grade the better
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frank Wieber
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frank Wieber, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424094
- Sponsor's protocol ID
- HRQoL_29.12.21
- Status last verified
- Jun 2022
- First submitted
- 25 Nov 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life in Overweight and Obese Children/Adolescents - a Pilot Project in the 'Kinderleicht' Group Programme
- ClinicalTrials.gov ID
- NCT05424094
- Acronym / sponsor ID
- HRQoL_29.12.21
- Conditions
- Obesity, Childhood, Health Related Quality of Life, Intervention Program, Obesity, Adolescent, Overweight and Obesity
- Keywords
- obesity, overweight, health related quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Frank WieberUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 21 Jun 2022 (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 primary aim of the present study is to record changes in the health-related quality of life (HRQoL) of children/adolescents participating in the multi-professional group programme 'kinderleicht' in 2022 over the course of the eleven-month active phase. In addition, these data will be examined for correlation with changes in BMI, waist and hip circumference, and motor performance.
Secondarily, the study addresses the questions of whether the recording of HROoL by means of the KINDL questionnaire is practicable for the programme leaders and what benefit can be gained from the analysed data for future cohorts.
Detailed description
According to the 2021 publication of the WHO European Childhood Obesity Surveillance Initiative (COSI), overweight and obesity in children and adolescents remains one of the most serious health problems facing the European population in the 21st century. The WHO responded to this problem in 2019 with a review paper on the propagated intervention approaches. With its developed national guidelines, Switzerland relies on multiprofessional group programmes. One of the eleven currently tested and certified programmes is 'kinderleicht' in Chur. The nationwide KIDSSTEP study from 2014 - on which the nationwide guidelines for multiprofessional group programmes are based - shows that it is imperative to record the health-related quality of life (HRQoL) of the children and adolescents as well as their families. In practice, however, this evidence is still too little implemented. Using the example of 'kinderleicht', it is to show that the recording and documentation of HRQoL is practicable and can provide valuable insights for both programme participants and programme managers. The primary goal is to record the health-related quality of life of children and adolescents participating in the multi-professional group programme 'kinderleicht' in 2022 over the course of the eleven-month active phase. At the same time, these data are to be correlated and interpreted with changes in BMI, waist and hip circumference and motor performance. Secondarily, possible sensitive/difficult phases of a participant during the active phase of the intervention will be identified in order to provide the best possible coaching to the families of future cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 'kinderleicht' programme | Experimental | Behavioral: multi-professional group programme 'kinderleicht'Children receive coaching in the areas of behaviour, exercise, nutrition and medicine from qualified professionals. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- girls/boys aged 7-17 years.
- participation with children
- age-adjusted BMI: P > 97th percentile or 90th-97th percentile + diseases whose prognosis is worsened by the overweight or are the result of the overweight
- medical examination unobjectionable
- motivation to participate in the programme is given
Key exclusion criteria (5 listed)
- BMI < 90 percentile
- not part of 'easy for children
- medical examination questionable
- no motivation to participate in the programme
- no verbal and/or written consent of the children and their parents/legal representatives
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 |
|---|---|---|
| multi-professional group programme 'kinderleicht'12-16 children/adolescents who participate in the multi-professional group programme 'kinderleicht' receive coaching in the areas of behaviour, exercise, nutrition and medicine from qualified professionals on fridays during 11 months. | Behavioural | 'kinderleicht' programme |
Primary outcome
health related quality of life (HRQoL) over 11 months
Time frame: 11 months
measured with the 'KINDL'-questionair; linkert scaled with a maximum value of 100 and a minimum value of 0 (points); the higher the score the better
3 secondary outcomes
Rate of Body Mass Index (BMI) over 11 months
Time frame: 11 months
hip-waist ratio
Time frame: 11 months
motor performance
Time frame: 11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing multi-professional group programme 'kinderleicht' in people with Obesity, Childhood and Health Related Quality of Life, run by Frank Wieber.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
health related quality of life (HRQoL) over 11 months (time frame: 11 months). 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 21 Jun 2022.