CArdioMetabolic Prevention in Adolescents (CAMP)

CArdioMetabolic Prevention in Adolescents With Body Weight Issues: the Effect of Group Intervention and Telemedicine

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

Study Overview

• Status: Recruiting
• Conditions: Body Weight Changes; Adolescent Obesity; Life Style, Healthy; Cardiometabolic Syndrome
• Intervention / Treatment: Behavioral: lifestyle education

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irena Aldhoon Hainerova, MD, PhD.; Phone Number: 00420267162561; Email: irena.aldhoon@fnkv.cz
• Study Contact Backup: Name: Kristína Rucklova, MD, PhD; Phone Number: 00420267162561; Email: kristina.rucklova@fnkv.cz

Study Locations

• Czechia
  • Prague, Czechia, 10034
    • Recruiting
    • Faculty Hospital Královské Vinohrady
    • Contact: Irena Aldhoon; Phone Number: 00420267162561; Email: ihainer@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group supported through group education and telemedicine tools; the group of this pilot study will be compared to conventional obesity clinic	Behavioral: lifestyle education; education on healthy lifestyle through group sessions and telemedicine tools

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on body composition of an accompanied adult person	change of percentage of fat mass assessed by bioimpedance before and after the 12-week intervention	12 weeks
Effect on body weight of an accompanied adult person	change of body weight in kg before and after the 12-week intervention	12 weeks

Collaborators and Investigators

• Sponsor: Faculty Hospital Kralovske Vinohrady
• Investigators: Principal Investigator: Irena D Aldhoon Hainerova, MD PhD, Fakultní Nemocnice Královské Vinohrady

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 24, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 24, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: obesity; telemedicine; adolescents; cardiometabolic health
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Insulin Resistance; Hyperinsulinism; Obesity; Metabolic Syndrome; Pediatric Obesity; Body Weight; Body Weight Changes
• Other Study ID Numbers: KDD FNKV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No