An interventional study of Treatment and handling obesity-related comorbidities in adolescents through exercise in Adolescent Obesity, Hypertension,Essential and Non-Alcoholic Fatty Liver Disease, sponsored by University of Lisbon. Not yet recruiting. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by University of Lisbon · Not applicable, Interventional, and Treatment
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.
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. Participants/patients followed at the Pediatric Obesity Clinic (HSM, CHULN) for at least 6 months and living in Lisbon area, will be eligible for recruitment. After inclusion/exclusion criteria checking, and informed consent/assent 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 (i.e., height, weight, BMI z-score/BMI, waist and hip circumference, body fat mass, and skeletal muscle mass); (iii) clinical data (i.e., 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 participant(s) 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 times/week), time (45 or 60 min/session) or protocol (aerobic or combined training), in a random order. Each participant will be exposed only to one exercise routine change (i.e., 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 participant(s) 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-up/standard care. During the follow-up phase, the exercise-based intervention will cease, and the participant(s) 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).
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 24 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University of Lisbon is the lead sponsor of 40 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
There is no registry of any clinically relevant adverse or unintended event associated with this kind of intervention. Nevertheless, adolescents with severe obesity may be at higher risk of both traumatic and overuse exercise-related injuries. A specific insurance for special risk participants, covering exercise-related injuries and dead (Appendix 1), will be activated in case of any adverse or unintended event during or as consequence of the exercise sessions. The impact of that specific event will be additionally analyzed and reported by the health professionals.
Behavioral: Treatment and handling obesity-related comorbidities in adolescents through exercise
Tailor-made, one-to-one, physical exercise program
Body Mass Index (BMI) z-score
Calculated according to World Health Organization (WHO) data, using the WHO AnthroPlus calculator (version 1.0.4)
Time frame: 6 (end of intervention) and 12 months (end of follow-up)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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University of Lisbon