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

NCT06520800 | Not Yet Recruiting

• 1 other identifier: THOR-X
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Adolescent Obesity; Obesity treatment; Physical activity; Exercise

Outcome Measures

Primary Outcomes (1)

• Body Mass Index (BMI) z-score

  Calculated according to World Health Organization (WHO) data, using the WHO AnthroPlus calculator (version 1.0.4)

  6 (end of intervention) and 12 months (end of follow-up)

Study Arms (1)

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.

Behavioral: Treatment and handling obesity-related comorbidities in adolescents through exercise

Interventions

Treatment and handling obesity-related comorbidities in adolescents through exercise BEHAVIORAL

Tailor-made, one-to-one, physical exercise program

Traumatic and overuse exercise-related injuries

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lisbon: lead
• Lusofona University: collaborator

MeSH Terms

Conditions

Pediatric Obesity; Essential Hypertension; Non-alcoholic Fatty Liver Disease; Dyslipidemias; Metabolic Diseases; Metabolic Syndrome; Motor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Lipid Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Behavior

Central Study Contacts

Helena Fonseca, Ph.D

CONTACT

966329031; helenaregalofonseca@gmail.com

Helena Fonseca Fonseca, Ph.D

CONTACT

helenaregalofonseca@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Series of n-of-1 trials

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 25, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 29, 2024

Record last verified: 2024-07