CArdioMetabolic Prevention in Adolescents

Body Weight Changes Clinical Trial

— CAMP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05350111
• Other study ID #: KDD FNKV
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Faculty Hospital Kralovske Vinohrady
• Contact: Irena Aldhoon Hainerova, MD, PhD.
• Phone: 00420267162561
• Email: irena.aldhoon[@]fnkv.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Obesity
• Body Weight
• Body Weight Changes
• Cardiometabolic Syndrome
• Life Style, Healthy
• Metabolic Syndrome
• Pediatric Obesity

Intervention

Behavioral:
• lifestyle education
education on healthy lifestyle through group sessions and telemedicine tools

Locations

Country	Name	City	State
Czechia	Faculty Hospital Kralovske Vinohrady	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Hospital Kralovske Vinohrady

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Effect on body weight of an accompanied adult person	change of body weight in kg before and after the 12-week intervention	12 weeks