Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05350111
Status:
UNKNOWN
Last Update Posted:
2022-04-27
First Post:
2022-03-29
Brief Title:
CArdioMetabolic Prevention in Adolescents
Sponsor:
Faculty Hospital Kralovske Vinohrady
Organization:
Faculty Hospital Kralovske Vinohrady
Study Overview
Official Title:
CArdioMetabolic Prevention in Adolescents With Body Weight Issues the Effect of Group Intervention and Telemedicine
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMP
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None