Treatment and Handling Severe Obesity-Related Comorbidities in Adolescents Through Exercise

Sponsor
University of Lisbon
Study ID
NCT06520800
Status
Not Yet Recruiting

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Conditions

  • Adolescent Obesity
  • Dyslipidemias
  • Hypertension,Essential
  • Metabolic Disease
  • Metabolic Syndrome
  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
13 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Treatment and handling obesity-related comorbidities in adolescents through exercise — BEHAVIORAL
    Tailor-made, one-to-one, physical exercise program

Study Details

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.

Key Dates

First listed
Jul 25, 2024
Start date
Jan 31, 2025
Status verified
Jul 2024
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Traumatic and overuse exercise-related injuries
    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.

Primary Outcome Measure

Body Mass Index (BMI) z-score [ Time Frame: 6 (end of intervention) and 12 months (end of follow-up) ]

Central Contacts

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