Reprogramming Energy Homeostasis in Overweight Children and Adults Trough Exercise, Cognitive Training and Social Interaction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- In Vivo Leptin Sensitivity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a condition of overweight or obesity
- •Intelligence Quotient (IQ) ≥ 85
排除标准
- •genetic or syndromic obesity;
- •reduced mobility;
- •systemic diseases;
- •ongoing pharmacological treatment for chronic conditions.
研究组 & 干预措施
Intensive Health Behavior Treatment group: Physical Activity and Diet
Participants will be provided with a personalized dietary plan and a Physical Activity training
干预措施: Nutritional Intervention (Other)
Intensive Health Behavior Treatment group: Physical Activity and Diet
Participants will be provided with a personalized dietary plan and a Physical Activity training
干预措施: Physical Activity training (Other)
Cognitive Training group: Physical Activity, Diet and an online cognitive training
Participants will be provided with personalized dietary plan, a Physical Activity training, and an online cognitive training.
干预措施: Nutritional Intervention (Other)
Cognitive Training group: Physical Activity, Diet and an online cognitive training
Participants will be provided with personalized dietary plan, a Physical Activity training, and an online cognitive training.
干预措施: Physical Activity training (Other)
Cognitive Training group: Physical Activity, Diet and an online cognitive training
Participants will be provided with personalized dietary plan, a Physical Activity training, and an online cognitive training.
干预措施: Cognitive training (Other)
Social Training group: Physical Activity, Diet and cognitive training
Participants will be provided with personalized dietary plan, a Physical Activity training, and a peer interaction program in ecological context.
干预措施: Nutritional Intervention (Other)
Social Training group: Physical Activity, Diet and cognitive training
Participants will be provided with personalized dietary plan, a Physical Activity training, and a peer interaction program in ecological context.
干预措施: Physical Activity training (Other)
Social Training group: Physical Activity, Diet and cognitive training
Participants will be provided with personalized dietary plan, a Physical Activity training, and a peer interaction program in ecological context.
干预措施: Social Training (Other)
结局指标
主要结局
In Vivo Leptin Sensitivity
时间窗: 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.
Leptin sensitivity will be evaluated as the ratio between caloric intake during an experimental meal and circulating leptin levels. Participants will receive a standardized breakfast and after 3 hours an ad libitum lunch, with detailed records of consumption, additional food requests, and portion sizes. Hunger and satiety will be measured using a 5-item Visual Analogue Scale (VAS) at multiple time points, recorded in millimeters. Energy and nutrient intake will be assessed using nutritional labels from each food item, and leptin sensitivity will be determined via plasma fasting.
Ex Vivo Leptin Sensitivity
时间窗: 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.
Since direct assessment of leptin sensitivity in the central nervous system is not feasible in humans, peripheral leptin sensitivity ex vivo will be evaluated using Peripheral Blood Mononuclear Cells (PBMCs). PBMCs will be collected from the same individuals before and after the intervention and exposed to recombinant leptin to assess intracellular signalling activation. The primary leptin effector pathway is Janus kinase 2/signal transducer and activator of transcription 3 (JAK2/STAT3), though Extracellular signal-regulated protein kinases 1 and 2 (ERK1/2) activation has also been reported among others. The activation of these pathways will be measured using immunoassays such as Enzyme Linked Immunosorbent Assay (ELISA) and Western blot, quantifying the ratio of phosphorylated to total protein levels for each intracellular effector.
Insulin Sensitivity and Secretion
时间窗: 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 will be assessed both during fasting and the oral glucose tolerance test (OGTT).
Energy Metabolism
时间窗: 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, including resting metabolic rate and diet-induced thermogenesis, will be measured by indirect calorimetry.
Fat Mass (percentage)
时间窗: 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 will be estimated using bioelectrical impedance analysis and expressed as a percentage of total body weight.
Fat Mass (kilograms)
时间窗: 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 will be estimated using bioelectrical impedance analysis and expressed in kilograms.
次要结局
- Muscle Strength: Upper Limb Strength(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.)
- Abdominal Strength and Endurance(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.)
- Balance(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.)
- Non-Verbal Fluid Intelligence(At baseline (T0))
- Working Memory(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(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(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(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(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(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.)
- Social Skills(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(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(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(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(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(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: Lateral Trunk Flexion Test(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.)
- Quality of Life: Physical, Emotional, Social, and School Functioning(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.)
- Social Adaptive Skills(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.)
- Eating Behavior and Disorders(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.)
- Sleep Habits and Quality(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.)
- Brain Function(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.)
- Plasma Analysis(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.)
- Gut Microbioma(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.)
- Muscle Strength: Handgrip Strength(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.)
- Lower Limb Explosive Strength(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.)
研究者
Melania Manco
Medical Director, Preventive and Predictive Medicine
Bambino Gesù Hospital and Research Institute