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NCT06931730Recruiting

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

Reprogramming Energy Homeostasis in Overweight Children and Adults Trough Exercise, Cognitive Training and Social Interaction

Source: ClinicalTrials.gov · Last updated 17 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
240 (estimated)
First submitted
24 Mar 2025
Start date
8 Feb 2024
Primary completion date
31 Dec 2025
Lead sponsor
Bambino Gesù Hospital and Research Institute
Diseases
Obesity
NCT number
NCT06931730

What you commit to

  • Study type: Interventional
  • Planned participants: 240
  • From 8 Feb 2024 to the primary completion date, 31 Dec 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • systemic diseases;
  • ongoing pharmacological treatment for chronic conditions.

Other

  • genetic or syndromic obesity;
  • reduced mobility;

Who the study is looking for

  • a condition of overweight or obesity
  • Intelligence Quotient (IQ) ≥ 85

Age in the registry: 6 years to 11 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Bambino Gesù Hospital and Research Institute,
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Ospedale Pediatrico Bambino Gesù
Coordinator of this site? Confirm its status
RomeItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.