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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 11
Healthy Volunteers: f
View:

• a condition of overweight or obesity

• Intelligence Quotient (IQ) ≥ 85

Locations
Other Locations
Italy
Bambino Gesù Hospital and Research Institute,
RECRUITING
Rome
Ospedale Pediatrico Bambino Gesù
RECRUITING
Rome
Contact Information
Primary
Melania Manco
melania.manco@opbg.net
+39 3317775547
Time Frame
Start Date: 2024-02-08
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 240
Treatments
Active_comparator: Intensive Health Behavior Treatment group: Physical Activity and Diet
Participants will be provided with a personalized dietary plan and a Physical Activity training
Active_comparator: Cognitive Training group: Physical Activity, Diet and an online cognitive training
Participants will be provided with personalized dietary plan, a Physical Activity training, and an online cognitive training.
Active_comparator: Social Training group: Physical Activity, Diet and cognitive training
Participants will be provided with personalized dietary plan, a Physical Activity training, and a peer interaction program in ecological context.
Related Therapeutic Areas
Sponsors
Leads: Bambino Gesù Hospital and Research Institute

This content was sourced from clinicaltrials.gov