CArdioMetabolic Prevention in Adolescents

NCT05350111 | Unknown

• 1 other identifier: KDD FNKV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Adolescent Obesity; Life Style, Healthy; Body Weight Changes; Cardiometabolic Syndrome

Keywords

adolescents; obesity; cardiometabolic health; telemedicine

Outcome Measures

Primary Outcomes (5)

• Effect on anthropometry parameters

  change of z-score of body mass index (in kg/m2) before and after the 12-week intervention (successful intervention should lead to a decline of z-score BMI)

  12 weeks

• Effect on depression

  change in Beck depression score before and after the 12 weeks of intervention (range: 0-60 points, no depression = 0-10 points, mild depression = 10-20 points, moderate depression = 20-40 points, severe depression = 40-60 points)

  12 weeks

• Effect on fitness

  change of fitness level assessed by 6-minute walk test before and after the 12 weeks of intervention (evaluated by the distance reached within the 6-minute walk test)

  12 weeks

• Effect on quality of life

  change of score of quality of life (assessed by KIDSCREEN questionnaire, the higher the score, the higher quality of life)

  12 weeks

• Effect on eating behavior

  change of score assessing cognitive restraint (greater the score, greater the restraint), disinhibition of control over eating (greater the score, greater the disinhibition) and perceived hunger (greater the score, greater the hunger) via Eating Inventory questionnaire before and after the 12 weeks of intervention

  12 weeks

Secondary Outcomes (2)

• Effect on body composition of an accompanied adult person

  12 weeks

• Effect on body weight of an accompanied adult person

  12 weeks

Study Arms (1)

group supported through group education and telemedicine tools

OTHER

the group of this pilot study will be compared to conventional obesity clinic

Behavioral: lifestyle education

Interventions

lifestyle education BEHAVIORAL

education on healthy lifestyle through group sessions and telemedicine tools

group supported through group education and telemedicine tools

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• genetic forms of obesity
• obesity due to endocrinopathy

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead

Study Sites (1)

Faculty Hospital Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Body Weight Changes; Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Irena D Aldhoon Hainerova, MD PhD

  Fakultní nemocnice Královské Vinohrady

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irena Aldhoon Hainerova, MD, PhD.

CONTACT

00420267162561; irena.aldhoon@fnkv.cz

Kristína Rucklova, MD, PhD

CONTACT

00420267162561; kristina.rucklova@fnkv.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. M.D., Ph.D.

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 27, 2022
• Study Start: March 27, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

CZ (1)