Reprogramming Energy Homeostasis in Overweight Individuals Via Exercise, Cognitive, and Social Training

Официальное название

Reprogramming Energy Homeostasis in Overweight Children and Adults Trough Exercise, Cognitive Training and Social Interaction

Обзор

The RESILIENT project is a clinical trial investigating leptin sensitivity in both children and adults with overweight or obesity. The study examines the additive effects of Cognitive Training (CT) and Social Training (ST) on leptin sensitivity, compared to stand-alone Intensive Health Behaviour Treatment (IHBT), which includes diet and Physical Activity (PA). The intervention will last for 8 weeks, followed by a 12-week washout period. A multilevel assessment will be conducted, evaluating in vivo leptin sensitivity (through the ratio of leptin levels to caloric intake) as well as ex vivo molecular analysis of leptin signaling in Peripheral Blood Mononuclear Cells (PBMCs). Additionally, clinical, psychological, cognitive, and physiological assessments will be performed to assess the efficacy of each intervention. By investigating leptin resistance as a potential molecular bridge between metabolic dysregulation and cognitive dysfunctions, this study may contribute to the development of more effective, long-term treatments for obesity and overweight. Additionally, in vivo investigation of leptin sensitivity may be particularly important for providing evidence of the metabolic and cognitive effects necessary for developing novel anti-obesity treatments.

Вмешательства

• Другое Nutritional Intervention
  Participants will receive comprehensive dietary education from the nutritionists of the research team, aimed at improving their baseline diet by incorporating nutritional recommendations based on the Mediterranean diet and the Italian dietary guidelines for healthy eating.
• Другое Physical Activity training
  Participants will engage in a structured exercise program designed to improve motor competence and confidence. Tailored to each individual's baseline physical abilities and cardiorespiratory capacity, the program will focus on enhancing aerobic fitness, flexibility, and coordination.
• Другое Cognitive training
  Participants will undergo an online cognitive training program, with a particular focus on memory enhancement.
• Другое Social Training
  A peer interaction program within an ecological setting, meant as a natural context of daily life, will be offered to participants. The program aims to improve active listening skills, comprehension of various communication styles (passive, assertive, aggressive), and the efficient recognition and management of emotions.

Первичные конечные точки

• In Vivo Leptin Sensitivity [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Ex Vivo Leptin Sensitivity [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Insulin Sensitivity and Secretion [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Energy Metabolism [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Fat Mass (percentage) [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Fat Mass (kilograms) [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]

Вторичные конечные точки (12)

• Non-Verbal Fluid Intelligence [Срок оценки: At baseline (T0)]
• Working Memory [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Sustained Attention and inhibitory control [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Episodic Long-Term Memory [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Visual-Motor Integration [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Gross and Fine Motor Skills [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Short-Term Memory [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Behavioral and Emotional Symptoms [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Ankle Dorsiflexion [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Joint Mobility [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Trunk Strength [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]
• Flexibility: Sit and Reach Test [Срок оценки: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.]

Критерии участия

Критерии включения

• a condition of overweight or obesity
• Intelligence Quotient (IQ) ≥ 85

Критерии исключения

• genetic or syndromic obesity;
• reduced mobility;
• systemic diseases;
• ongoing pharmacological treatment for chronic conditions.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 2 центра

• Ospedale Pediatrico Bambino Gesù — Rome
• Bambino Gesù Hospital and Research Institute, — Rome

Публикации

• Russo V, Menghini D, Mainardi M, Fintini D, Aureli A, Gianni N, Rava L, Rea MA, Scozia G, Spiezia C, Scabia G, Furini G, Vicari S, Cianfarani S, Maffei M, Manco M. Reprogramming energy homeostasis in children with overweight through cognitive training and social interaction. A study protocol to estimate leptin sensitivity. Front Endocrinol (Lausanne). 2025 Jun 18;16:1606132. doi: 10.3389/fendo.202 PMID 40607230

Идентификаторы

NCT: NCT06931730 · PNRR-MAD-2022-12376459

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗