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

Bambino Gesù Hospital and Research Institute

Status: Enrolling

Conditions: Leptin Resistance; Obesity and Overweight; Childhood Obesity

Treatments: Other: Social Training; Other: Physical Activity training; Other: Nutritional Intervention; Other: Cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT06931730

PNRR-MAD-2022-12376459

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Intensive Health Behavior Treatment group: Physical Activity and Diet

Active Comparator group

Description:

Participants will be provided with a personalized dietary plan and a Physical Activity training

Treatment:

Other: Nutritional Intervention

Other: Physical Activity training

Cognitive Training group: Physical Activity, Diet and an online cognitive training

Active Comparator group

Description:

Participants will be provided with personalized dietary plan, a Physical Activity training, and an online cognitive training.

Treatment:

Other: Cognitive training

Other: Nutritional Intervention

Other: Physical Activity training

Social Training group: Physical Activity, Diet and cognitive training

Active Comparator group

Description:

Participants will be provided with personalized dietary plan, a Physical Activity training, and a peer interaction program in ecological context.

Treatment:

Other: Nutritional Intervention

Other: Social Training

Other: Physical Activity training