Clinical trial NCT05350111: CArdioMetabolic Prevention in Adolescents
Official title: CArdioMetabolic Prevention in Adolescents With Body Weight Issues: the Effect of Group Intervention and Telemedicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Obesity
Life Style, Healthy
Body Weight Changes
Cardiometabolic Syndrome
Keywords: adolescents
obesity
cardiometabolic health
telemedicine
Lead sponsor: Faculty Hospital Kralovske Vinohrady
Sponsor class: OTHER_GOV
First posted: 2022-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect on anthropometry parameters
timeFrame: 12 weeks
measure: Effect on depression
timeFrame: 12 weeks
measure: Effect on fitness
timeFrame: 12 weeks
measure: Effect on quality of life
timeFrame: 12 weeks
measure: Effect on eating behavior
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect on body composition of an accompanied adult person
timeFrame: 12 weeks
measure: Effect on body weight of an accompanied adult person
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
Study officials:
affiliation: Fakultní nemocnice Královské Vinohrady
name: Irena D Aldhoon Hainerova, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: