Adolescent ObesityTHOR-XNCT06520800
Treatment and Handling Severe Obesity-Related Comorbidities in Adolescents Through Exercise
A study testing Treatment and handling obesity-related comorbidities in adolescents through exercise in people with Adolescent Obesity and Hypertension,Essential, run by University of Lisbon.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Adolescent Obesity, Hypertension,Essential, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Treatment and handling obesity-related comorbidities in adolescents through exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- adolescents aged 13 to 18 years;
- of any gender (including transgender adolescents);
- with severe obesity (≥3.0 BMI z-score) [24];
- with any obesity-related comorbidity (e.g., hypertension, IR or DMT2, dyslipidemia, eating disorders, depression/anxiety);
- at least 6 months of follow-up at the Pediatric Obesity Clinic (HSM, CHULN) at the time of recruitment;
- living in Lisbon area;
- informed consent/assent signature.
Who cannot join
- major or unstable clinical conditions (other than obesity or its related comorbidities);
- inability to perform regular PA;
- pregnancy;
- mental disorders;
- smoking habits;
- being involved in another weight loss program.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Helena Fonseca Fonseca, Ph.D contact
About this study
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.
Read the 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. 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).
- Conditions
- Adolescent Obesity, Hypertension,Essential, Non-Alcoholic Fatty Liver Disease, Dyslipidemias, Metabolic Disease, Metabolic Syndrome
- Being tested
- Treatment and handling obesity-related comorbidities in adolescents through exercise
- Keywords
- Adolescent Obesity, Obesity treatment, Physical activity, Exercise
- Medical subject headings
- Pediatric Obesity, Essential Hypertension, Non-alcoholic Fatty Liver Disease, Dyslipidemias, Metabolic Diseases, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment and handling obesity-related comorbidities in adolescents through exerciseBehavioural
Tailor-made, one-to-one, physical exercise program
| Study group | Role | What they receive |
|---|---|---|
| Traumatic and overuse exercise-related injuries | Experimental | 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. Receives: Behavioral: Treatment and handling obesity-related comorbidities in adolescents through exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI) z-score
Calculated according to World Health Organization (WHO) data, using the WHO AnthroPlus calculator (version 1.0.4)
Measured: 6 (end of intervention) and 12 months (end of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Series of n-of-1 trials
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- Lusofona University
- Responsible party
- Principal investigator, A. Videira-Silva, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520800
- Sponsor's protocol ID
- THOR-X
- Acronym
- THOR-X
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Handling Severe Obesity-Related Comorbidities in Adolescents Through Exercise
- ClinicalTrials.gov ID
- NCT06520800
- Acronym / sponsor ID
- THOR-X / THOR-X
- Conditions
- Adolescent Obesity, Hypertension,Essential, Non-Alcoholic Fatty Liver Disease, Dyslipidemias, Metabolic Disease, Metabolic Syndrome
- Keywords
- Adolescent Obesity, Obesity treatment, Physical activity, Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Collaborators
- Lusofona University
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Series of n-of-1 trials
| Arm | Type | Receives |
|---|---|---|
| Traumatic and overuse exercise-related injuries | Experimental | Behavioral: Treatment and handling obesity-related comorbidities in adolescents through exerciseThere 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- adolescents aged 13 to 18 years;
- of any gender (including transgender adolescents);
- with severe obesity (≥3.0 BMI z-score) [24];
- with any obesity-related comorbidity (e.g., hypertension, IR or DMT2, dyslipidemia, eating disorders, depression/anxiety);
- at least 6 months of follow-up at the Pediatric Obesity Clinic (HSM, CHULN) at the time of recruitment;
Key exclusion criteria (6 listed)
- major or unstable clinical conditions (other than obesity or its related comorbidities);
- inability to perform regular PA;
- pregnancy;
- mental disorders;
- smoking habits;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment and handling obesity-related comorbidities in adolescents through exerciseTailor-made, one-to-one, physical exercise program | Behavioural | Traumatic and overuse exercise-related injuries |
Primary outcome
Body Mass Index (BMI) z-score
Time frame: 6 (end of intervention) and 12 months (end of follow-up)
Calculated according to World Health Organization (WHO) data, using the WHO AnthroPlus calculator (version 1.0.4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helena Fonseca Fonseca, Ph.D contact
Questions about this trial
What is this clinical trial studying?
A study testing Treatment and handling obesity-related comorbidities in adolescents through exercise in people with Adolescent Obesity and Hypertension,Essential, run by University of Lisbon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helena Fonseca, Ph.D (966329031, helenaregalofonseca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) z-score (time frame: 6 (end of intervention) and 12 months (end of follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.