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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorBambino Gesù Hospital and Research Institute

About this trial

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

Qualifiers

a condition of overweight or obesity

Intelligence Quotient (IQ) ≥ 85

Disqualifiers

genetic or syndromic obesity;

reduced mobility;

systemic diseases;

ongoing pharmacological treatment for chronic conditions.

Trial design

Treatments tested in this trial

  • Nutritional Intervention
  • Physical Activity training
  • Cognitive training
  • Social Training

Treatment groups

240 Participants
are divided into 3 treatment groups