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临床试验/NCT06520800
NCT06520800尚未招募不适用

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

University of Lisbon0 个研究点目标入组 24 人开始时间: 2025年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
主要终点
Body Mass Index (BMI) z-score

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Body Mass Index (BMI) z-score

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

A. Videira-Silva

Professor

University of Lisbon

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