Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-03-27
2023-12-31
Brief Summary
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The study aims to investigate:
* the effect of 12-week intervention on body weight, anthropometry parameters and cardiometabolic markers in comparison to the conventionally led obesity clinic for adolescents
* the compliance with telemedicine tools that will focus on the support of balance nutrition, physical activity (evaluation of daily steps through smart bands) and family well being in regards to the effect on anthropometry and laboratory parameters
* the effect of the intervention on data from questionnaires (eating disorders, quality of life, psychological health) before and after the intervention
* data analysis of family members with respect to theirs offspring
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Detailed Description
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For those included, a detailed history, laboratory (routine investigation additionally to serum storage and stool for microbiome analysis) and physical examination will be assessed during the initial visit in the outpatient clinic. During one day group intervention each adolescent with at least one family member will undergo education session on nutrition, healthy eating and physiological support incl. cognitive behavioral sessions. There will be an assessment of individual fitness and participants will try different suitable options to increase their daily physical activity. Participants will be asked to bring filled questionnaires that address different aspects of lifestyle and psychological well being. A detailed anthropometry examination and body composition will also be performed. An ultrasound examination of carotid intima-media thickness and visceral fat mass measurements will be assessed in all adolescents. The body composition, body weight and height will also be measured in all accompanied family members. All participants will receive smart bands for the following 12 weeks to support physical activity and monitor their daily step count.
This group intervention will be followed by a12-week time period in which telemedicine tools and frequent virtual contacts will be done to support family healthy lifestyle.
After 12 weeks a group session will be undertaken in order to evaluate all aspects of lifestyle through repeated questionnaire survey. Laboratory, ultrasound and anthropometry examination will be done in order to monitor the effect of this intervention and compared to participants visiting the conventional obesity clinic of our hospital. A further follow-up will be offered to all participants.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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group supported through group education and telemedicine tools
the group of this pilot study will be compared to conventional obesity clinic
lifestyle education
education on healthy lifestyle through group sessions and telemedicine tools
Interventions
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lifestyle education
education on healthy lifestyle through group sessions and telemedicine tools
Eligibility Criteria
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Inclusion Criteria
* diagnosis of obesity = body mass index (in kg/m2) above 97th centile for age and sex
* obesity likely due to impaired healthy lifestyle
Exclusion Criteria
* obesity due to endocrinopathy
12 Years
19 Years
ALL
No
Sponsors
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Faculty Hospital Kralovske Vinohrady
OTHER_GOV
Responsible Party
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Irena Aldhoon Hainerova
Assoc. Prof. M.D., Ph.D.
Principal Investigators
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Irena D Aldhoon Hainerova, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Fakultní nemocnice Královské Vinohrady
Locations
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Faculty Hospital Kralovske Vinohrady
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KDD FNKV
Identifier Type: -
Identifier Source: org_study_id
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