CArdioMetabolic Prevention in Adolescents

NCT ID: NCT05350111

Last Updated: 2022-04-27

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-27

Study Completion Date

2023-12-31

Brief Summary

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The aim of the CArdioMetabolic Prevention (CAMP) pilot study is to investigate the effect of a group intervention on lifestyle in adolescents and on at least one adult family member. This will be followed by telemedicine tools for 12-week-time period. A face-to-face group intervention addressing nutrition, physical activity and well being together with an assessment of anthropometry parameters, body composition, questionnaires, blood and stool sampling will be done before and after 12 weeks of telemedicine.

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

Detailed Description

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In a 12-month pilot study it is expected to include four groups composed of 10-12 adolescent participants with increased body weight. The participants will be recruited from new patients attending pediatric endocrine clinics in the Department of Children and Adolescents of Faculty Hospital Kralovske Vinohrady and Third Faculty of Medicine Charles University.

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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Adolescent Obesity Life Style, Healthy Body Weight Changes Cardiometabolic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

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

Group Type OTHER

lifestyle education

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age range: 12-19 years
* 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

* genetic forms of obesity
* obesity due to endocrinopathy
Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculty Hospital Kralovske Vinohrady

OTHER_GOV

Sponsor Role lead

Responsible Party

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Irena Aldhoon Hainerova

Assoc. Prof. M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Irena Aldhoon Hainerova, MD, PhD.

Role: CONTACT

00420267162561

Kristína Rucklova, MD, PhD

Role: CONTACT

00420267162561

Facility Contacts

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Irena Aldhoon

Role: primary

00420267162561

Other Identifiers

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KDD FNKV

Identifier Type: -

Identifier Source: org_study_id

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