Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06931730

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 11 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity and Overweight, Leptin Resistance, Childhood Obesity

Full registry criteria

Inclusion Criteria: * a condition of overweight or obesity * Intelligence Quotient (IQ) ≥ 85 Exclusion Criteria: * genetic or syndromic obesity; * reduced mobility; * systemic diseases; * ongoing pharmacological treatment for chronic conditions.

Treatments and study arms

Nutritional Intervention

Other

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.

Physical Activity training

Other

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.

Cognitive training

Other

Participants will undergo an online cognitive training program, with a particular focus on memory enhancement.

Social Training

Other

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.

Primary outcomes

In Vivo Leptin SensitivityAt 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 SensitivityAt 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 SecretionAt 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 MetabolismAt 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)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)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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Bambino Gesù Hospital and Research Institute,🇮🇹 Rome, Rome, Italy

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Chiara MenniniContact

Email · Call 06-68592572

Ospedale Pediatrico Bambino Gesù🇮🇹 Rome, Italy, Italy

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