Clinical trial NCT06931730: Reprogramming Energy Homeostasis in Overweight Individuals Via Exercise, Cognitive, and Social Training
Official title: Reprogramming Energy Homeostasis in Overweight Children and Adults Trough Exercise, Cognitive Training and Social Interaction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity and Overweight
Leptin Resistance
Childhood Obesity
Keywords: childhood obesity
cognitive training
social training
environmental enrichment
leptin
lifestyle modification
overweight
obesity
energy expenditure
thermogenesis
physical activity
leptin sensitivity
leptin resistance
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: In Vivo Leptin Sensitivity
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Ex Vivo Leptin Sensitivity
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Insulin Sensitivity and Secretion
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Energy Metabolism
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Fat Mass (percentage)
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Fat Mass (kilograms)
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
Secondary outcomes:
measure: Non-Verbal Fluid Intelligence
timeFrame: At baseline (T0)
measure: Working Memory
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Sustained Attention and inhibitory control
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Episodic Long-Term Memory
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Visual-Motor Integration
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Gross and Fine Motor Skills
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Short-Term Memory
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Behavioral and Emotional Symptoms
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Ankle Dorsiflexion
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Joint Mobility
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Trunk Strength
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Flexibility: Sit and Reach Test
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Flexibility: Lateral Trunk Flexion Test
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Quality of Life: Physical, Emotional, Social, and School Functioning
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Social Adaptive Skills
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Social Skills
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Eating Behavior and Disorders
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Sleep Habits and Quality
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Brain Function
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Plasma Analysis
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Gut Microbioma
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Muscle Strength: Upper Limb Strength
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Muscle Strength: Handgrip Strength
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Lower Limb Explosive Strength
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Abdominal Strength and Endurance
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
measure: Balance
timeFrame: At baseline (T0), at the end of the 8-week intervention (T1, end of month 2), and 12 weeks after the intervention (T2, end of month 5) to verify the persistence of effects.
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Rome
country: Italy
facility: Bambino Gesù Hospital and Research Institute,
Study officials:
References: