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CArdioMetabolic Prevention in Adolescents (CAMP)

Primary Purpose

Adolescent Obesity, Life Style, Healthy, Body Weight Changes

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
lifestyle education
Sponsored by
Faculty Hospital Kralovske Vinohrady
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adolescent Obesity focused on measuring adolescents, obesity, cardiometabolic health, telemedicine

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty Hospital Kralovske VinohradyRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

group supported through group education and telemedicine tools

Arm Description

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

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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

Secondary Outcome Measures

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
Effect on body weight of an accompanied adult person
change of body weight in kg before and after the 12-week intervention

Full Information

First Posted
March 29, 2022
Last Updated
April 24, 2022
Sponsor
Faculty Hospital Kralovske Vinohrady
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1. Study Identification

Unique Protocol Identification Number
NCT05350111
Brief Title
CArdioMetabolic Prevention in Adolescents
Acronym
CAMP
Official Title
CArdioMetabolic Prevention in Adolescents With Body Weight Issues: the Effect of Group Intervention and Telemedicine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty Hospital Kralovske Vinohrady

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Obesity, Life Style, Healthy, Body Weight Changes, Cardiometabolic Syndrome
Keywords
adolescents, obesity, cardiometabolic health, telemedicine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group supported through group education and telemedicine tools
Arm Type
Other
Arm Description
the group of this pilot study will be compared to conventional obesity clinic
Intervention Type
Behavioral
Intervention Name(s)
lifestyle education
Intervention Description
education on healthy lifestyle through group sessions and telemedicine tools
Primary Outcome Measure Information:
Title
Effect on anthropometry parameters
Description
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)
Time Frame
12 weeks
Title
Effect on depression
Description
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)
Time Frame
12 weeks
Title
Effect on fitness
Description
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)
Time Frame
12 weeks
Title
Effect on quality of life
Description
change of score of quality of life (assessed by KIDSCREEN questionnaire, the higher the score, the higher quality of life)
Time Frame
12 weeks
Title
Effect on eating behavior
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Effect on body composition of an accompanied adult person
Description
change of percentage of fat mass assessed by bioimpedance before and after the 12-week intervention
Time Frame
12 weeks
Title
Effect on body weight of an accompanied adult person
Description
change of body weight in kg before and after the 12-week intervention
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irena Aldhoon Hainerova, MD, PhD.
Phone
00420267162561
Email
irena.aldhoon@fnkv.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Kristína Rucklova, MD, PhD
Phone
00420267162561
Email
kristina.rucklova@fnkv.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irena D Aldhoon Hainerova, MD PhD
Organizational Affiliation
Fakultní nemocnice Královské Vinohrady
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty Hospital Kralovske Vinohrady
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irena Aldhoon
Phone
00420267162561
Email
ihainer@hotmail.com

12. IPD Sharing Statement

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CArdioMetabolic Prevention in Adolescents

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