HRQoL in Overweight and Obese Children/Adolescents
Primary Purpose
Obesity, Childhood, Health Related Quality of Life, Intervention Program
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
multi-professional group programme 'kinderleicht'
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Childhood focused on measuring obesity, overweight, health related quality of life
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
'kinderleicht' programme
Arm Description
Children receive coaching in the areas of behaviour, exercise, nutrition and medicine from qualified professionals.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
hip-waist ratio
hip and waist circumference in centimetres are combined to hip-waist ratio
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05424094
Brief Title
HRQoL in Overweight and Obese Children/Adolescents
Official Title
Health-related Quality of Life in Overweight and Obese Children/Adolescents - a Pilot Project in the 'Kinderleicht' Group Programme
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Frank Wieber
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Health Related Quality of Life, Intervention Program, Obesity, Adolescent, Overweight and Obesity
Keywords
obesity, overweight, health related quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
'kinderleicht' programme
Arm Type
Experimental
Arm Description
Children receive coaching in the areas of behaviour, exercise, nutrition and medicine from qualified professionals.
Intervention Type
Behavioral
Intervention Name(s)
multi-professional group programme 'kinderleicht'
Intervention Description
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.
Primary Outcome Measure Information:
Title
health related quality of life (HRQoL) over 11 months
Description
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
Time Frame
11 months
Secondary Outcome Measure Information:
Title
Rate of Body Mass Index (BMI) over 11 months
Description
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
Time Frame
11 months
Title
hip-waist ratio
Description
hip and waist circumference in centimetres are combined to hip-waist ratio
Time Frame
11 months
Title
motor performance
Description
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
Time Frame
11 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
No
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HRQoL in Overweight and Obese Children/Adolescents
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