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

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.

Conditions

• Obesity and Overweight
• Leptin Resistance
• Childhood Obesity

Interventions

OTHER

Nutritional Intervention

Participants will receive comprehensive dietary education from the nutritionists of the research team, aimed at improving their baseline diet by incorporating nutritional recommendations based on the Mediterranean diet and the Italian dietary guidelines for healthy eating.

OTHER

Physical Activity training

Participants will engage in a structured exercise program designed to improve motor competence and confidence. Tailored to each individual's baseline physical abilities and cardiorespiratory capacity, the program will focus on enhancing aerobic fitness, flexibility, and coordination.

OTHER

Cognitive training

Participants will undergo an online cognitive training program, with a particular focus on memory enhancement.

OTHER

Social Training

A peer interaction program within an ecological setting, meant as a natural context of daily life, will be offered to participants. The program aims to improve active listening skills, comprehension of various communication styles (passive, assertive, aggressive), and the efficient recognition and management of emotions.

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

6 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-08

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Italy

Study Locations