Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520800
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Treatment and Handling Severe Obesity-Related Comorbidities in Adolescents Through Exercise
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Treatment and Handling Severe Obesity-Related Comorbidities in Adolescents Through Exercise
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THOR-X
Brief Summary:
The main objective of this project is to analyze the effect of a tailor-made one-to-one exercise program aiming to treat and handle obesity-related comorbidities in adolescents with severe obesity at high risk of cardiovascular disease development on BMI z-score specific comorbidities and other health-related indicators
This project will further allow to analyze the long-term impact of the exercise program not only on clinical parameters but also on the interaction with drug-treatment health-related behaviors and quality of life further contributing to the understanding of the individual characteristics associated with a positive exercise response and frequency
The secondary objective of the THOR-X project is to build an educational toolkit based on project results and relevant literature addressed to health and exercise professionals in order to improve management of adolescents with obesity in particular those with severe obesity
This project will further allow to analyze the long-term impact of the exercise program not only on clinical parameters but also on the interaction with drug-treatment health-related behaviors and quality of life further contributing to the understanding of the individual characteristics associated with a positive exercise response and frequency
The secondary objective of the THOR-X project is to build an educational toolkit based on project results and relevant literature addressed to health and exercise professionals in order to improve management of adolescents with obesity in particular those with severe obesity
Detailed Description:
The THOR-X project is designed as a series of n-of-1 trials with a crossover methodology Each trial will include 3 phases and 5 assessment times organized as follows
Phase 1 Retrospective phase Participantspatients followed at the Pediatric Obesity Clinic HSM CHULN for at least 6 months and living in Lisbon area will be eligible for recruitment After inclusionexclusion criteria checking and informed consentassent signature retrospective data from those who consent to participate will then be collected from clinical records Data will be collected from the first visit and last assessments before the beginning of the intervention baseline assessment which will represent the control phase The clinical records of the participants will be searched for i date of first appointment number of appointments attended length of clinical follow-up and emergency healthcare seeking ii anthropometric and body composition data ie height weight BMI z-scoreBMI waist and hip circumference body fat mass and skeletal muscle mass iii clinical data ie biochemical profile blood pressure and presence of clinical conditions including psychopathology iv physical activity and sedentary behaviors and v dietary habits
At baseline additionally to the clinical standard assessments the participants will accomplish a battery of assessments including socio-economic cardiorespiratory fitness objectively measured physical activity psycho-behavioral characteristics sleep quality and health-related quality of life These assessments will allow to analyze clinical changes before intervention control phase and collect relevant data not assessed previously to better analyze intervention effect
Phase 2 Intervention phase The exercise intervention phase will have a 6-month duration where participant will be exposed to two distinct exercise plans 3 months each Per each participant the two exercise plans will differ in terms of frequency 2 or 3 timesweek time 45 or 60 minsession or protocol aerobic or combined training in a random order Each participant will be exposed only to one exercise routine change ie frequency time or protocol The exercise sessions will take place at the Faculdade de Educação Física e Desporto Universidade Lusófona During the intervention period the participants will repeat twice at the end of the first and second exercise plans - 3 and 6-month the assessments previously performed These assessments will allow to explore the influence of exercise plan changes on the variables under study
Phase 3 Follow-upstandard care During the follow-up phase the exercise-based intervention will cease and the participants will be exposed only to standard care matching the level of exposure of phase 1 - control phase Standard care comprises appointments with the multidisciplinary team pediatrician nutritionist and exercise physiologist every 3 months at the clinic All the assessments performed at baseline will be repeated twice during the follow-up 12 and 18-month which will allow to analyze short- and long-term changes associated with lack of exposure to the exercise intervention phase 2
Phase 1 Retrospective phase Participantspatients followed at the Pediatric Obesity Clinic HSM CHULN for at least 6 months and living in Lisbon area will be eligible for recruitment After inclusionexclusion criteria checking and informed consentassent signature retrospective data from those who consent to participate will then be collected from clinical records Data will be collected from the first visit and last assessments before the beginning of the intervention baseline assessment which will represent the control phase The clinical records of the participants will be searched for i date of first appointment number of appointments attended length of clinical follow-up and emergency healthcare seeking ii anthropometric and body composition data ie height weight BMI z-scoreBMI waist and hip circumference body fat mass and skeletal muscle mass iii clinical data ie biochemical profile blood pressure and presence of clinical conditions including psychopathology iv physical activity and sedentary behaviors and v dietary habits
At baseline additionally to the clinical standard assessments the participants will accomplish a battery of assessments including socio-economic cardiorespiratory fitness objectively measured physical activity psycho-behavioral characteristics sleep quality and health-related quality of life These assessments will allow to analyze clinical changes before intervention control phase and collect relevant data not assessed previously to better analyze intervention effect
Phase 2 Intervention phase The exercise intervention phase will have a 6-month duration where participant will be exposed to two distinct exercise plans 3 months each Per each participant the two exercise plans will differ in terms of frequency 2 or 3 timesweek time 45 or 60 minsession or protocol aerobic or combined training in a random order Each participant will be exposed only to one exercise routine change ie frequency time or protocol The exercise sessions will take place at the Faculdade de Educação Física e Desporto Universidade Lusófona During the intervention period the participants will repeat twice at the end of the first and second exercise plans - 3 and 6-month the assessments previously performed These assessments will allow to explore the influence of exercise plan changes on the variables under study
Phase 3 Follow-upstandard care During the follow-up phase the exercise-based intervention will cease and the participants will be exposed only to standard care matching the level of exposure of phase 1 - control phase Standard care comprises appointments with the multidisciplinary team pediatrician nutritionist and exercise physiologist every 3 months at the clinic All the assessments performed at baseline will be repeated twice during the follow-up 12 and 18-month which will allow to analyze short- and long-term changes associated with lack of exposure to the exercise intervention phase 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None