NCT06931730 Reprogramming Energy Homeostasis in Overweight Individuals Via Exercise, Cognitive, and Social Training
| NCT ID | NCT06931730 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bambino Gesù Hospital and Research Institute |
| Condition | Obesity and Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-02-08 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2024-02-08 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06931730 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 11 Years, studying Obesity and Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06931730 currently recruiting?
Yes, NCT06931730 is actively recruiting participants. Contact the research team at melania.manco@opbg.net for enrollment information.
Where is the NCT06931730 trial being conducted?
This trial is being conducted at Rome, Italy, Rome, Italy.
Who is sponsoring the NCT06931730 clinical trial?
NCT06931730 is sponsored by Bambino Gesù Hospital and Research Institute. The trial plans to enroll 240 participants.
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