Actively Recruiting

Phase Not Applicable
Age: 6Years - 11Years
All Genders
NCT06931730

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

Age: 6Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A condition of overweight or obesity
  • Intelligence Quotient (IQ) 25 85
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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