Actively Recruiting
Reprogramming Energy Homeostasis in Overweight Individuals Via Exercise, Cognitive, and Social Training
Led by Bambino Gesù Hospital and Research Institute · Updated on 2025-04-17
240
Participants Needed
2
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Reprogramming Energy Homeostasis in Overweight Individuals Via Exercise, Cognitive, and Social Training
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A condition of overweight or obesity
- Intelligence Quotient (IQ) 25 85
You will not qualify if you...
- Genetic or syndromic obesity
- Reduced mobility
- Systemic diseases
- Ongoing pharmacological treatment for chronic conditions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Ospedale Pediatrico Bambino Gesù
Rome, Italy, Italy, 00146
Actively Recruiting
2
Bambino Gesù Hospital and Research Institute,
Rome, Rome, Italy, 00165
Actively Recruiting
Research Team
M
Melania Manco
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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