Reprogramming Energy Homeostasis in Overweight Individuals Via Exercise, Cognitive, and Social Training
Recruiting now · Not applicable
Conditions studied: Obesity and Overweight, Leptin Resistance, Childhood Obesity
In brief
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.
Key facts
- Study ID
- NCT06931730
- Run by
- Bambino Gesù Hospital and Research Institute
- People needed
- 240
- Starts
- 2024-02-08
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-04-17
Who can join
Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- a condition of overweight or obesity
- Intelligence Quotient (IQ) ≥ 85
You may not qualify if…
- genetic or syndromic obesity;
- reduced mobility;
- systemic diseases;
- ongoing pharmacological treatment for chronic conditions.
Where it is running
- Ospedale Pediatrico Bambino Gesù — Rome, Italy, Italy (enrolling)
- Bambino Gesù Hospital and Research Institute, — Rome, Rome, Italy (enrolling)
Full record on ClinicalTrials.gov
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