An interventional study of Nutritional Intervention and Physical Activity training in Obesity and Overweight, Leptin Resistance and Childhood Obesity, sponsored by Bambino Gesù Hospital and Research Institute. Recruiting at 2 sites in Italy. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Bambino Gesù Hospital and Research Institute · Not applicable, Interventional, and Treatment
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.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 240 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Bambino Gesù Hospital and Research Institute is the lead sponsor of 54 studies on the registry; 10 are open to participants now.
Compared within Pediatric Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obesity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Participants will be provided with a personalized dietary plan and a Physical Activity training
Other: Nutritional Intervention · Other: Physical Activity training
Participants will be provided with personalized dietary plan, a Physical Activity training, and an online cognitive training.
Other: Nutritional Intervention · Other: Physical Activity training · Other: Cognitive training
Participants will be provided with personalized dietary plan, a Physical Activity training, and a peer interaction program in ecological context.
Other: Nutritional Intervention · Other: Physical Activity training · Other: Social Training
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.
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.
Participants will undergo an online cognitive training program, with a particular focus on memory enhancement.
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.
In Vivo Leptin Sensitivity
Leptin sensitivity will be evaluated as the ratio between caloric intake during an experimental meal and circulating leptin levels. Participants will receive a standardized breakfast and after 3 hours an ad libitum lunch, with detailed records of consumption, additional food requests, and portion sizes. Hunger and satiety will be measured using a 5-item Visual Analogue Scale (VAS) at multiple time points, recorded in millimeters. Energy and nutrient intake will be assessed using nutritional labels from each food item, and leptin sensitivity will be determined via plasma fasting.
Time frame: 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.
Ex Vivo Leptin Sensitivity
Since direct assessment of leptin sensitivity in the central nervous system is not feasible in humans, peripheral leptin sensitivity ex vivo will be evaluated using Peripheral Blood Mononuclear Cells (PBMCs). PBMCs will be collected from the same individuals before and after the intervention and exposed to recombinant leptin to assess intracellular signalling activation. The primary leptin effector pathway is Janus kinase 2/signal transducer and activator of transcription 3 (JAK2/STAT3), though Extracellular signal-regulated protein kinases 1 and 2 (ERK1/2) activation has also been reported among others. The activation of these pathways will be measured using immunoassays such as Enzyme Linked Immunosorbent Assay (ELISA) and Western blot, quantifying the ratio of phosphorylated to total protein levels for each intracellular effector.
Time frame: 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.
Insulin Sensitivity and Secretion
Insulin sensitivity and secretion will be assessed both during fasting and the oral glucose tolerance test (OGTT).
Time frame: 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.
Energy Metabolism
Energy metabolism, including resting metabolic rate and diet-induced thermogenesis, will be measured by indirect calorimetry.
Time frame: 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.
Fat Mass (percentage)
Fat mass will be estimated using bioelectrical impedance analysis and expressed as a percentage of total body weight.
Time frame: 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.
Fat Mass (kilograms)
Fat mass will be estimated using bioelectrical impedance analysis and expressed in kilograms.
Time frame: 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.
Non-Verbal Fluid Intelligence
Assessed using the Colored Progressive Matrices (CPM), a standardized test that measures the ability to recognize patterns and solve problems without reliance on language. The outcome is the global Intelligent Quotient (IQ) score, with a mean of 100 and a standard deviation of 15, measured in standardized scores.
Time frame: At baseline (T0)
Working Memory
Evaluated through the N-Back Task, a computerized assessment of both visuo-spatial and verbal working memory. In the visuo-spatial condition, participants view randomly positioned blue boxes and determine whether the current position matches the previous one. In the verbal condition, they listen to a stream of letters and identify whether each letter matches the one immediately preceding it. The task adapts dynamically, increasing in difficulty when accuracy reaches or exceeds 80%. The outcome metric is the accuracy percentage at each difficulty level, measured in percentage of correct responses.
Time frame: 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.
Sustained Attention and inhibitory control
Measured using the Continuous Performance Test-II (CPT-II), a computerized assessment of sustained attention and inhibitory control. Participants respond to any letter except "X" (Go trials) and withhold responses when "X" appears (No-Go trials). Reaction times and response variability provide insights into attentional performance. The outcome metrics include accuracy, reaction time (RT) in milliseconds, and reaction time variability (RTV) in milliseconds.
Time frame: 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.
Episodic Long-Term Memory
To assess episodic long-term memory, the Verbal and Visual-Spatial Learning tasks from the standardized Battery for the evaluation of Memory (PROMEA) will be administered. The Verbal Learning Task presents a list of 15 unrelated words across 3 trials, followed by delayed recall after 15 minutes. Similarly, the Visual-Spatial Learning Task involves recalling the placement of 15 objects in 4 quadrants during 3 trials, with delayed recall after 15 minutes. The outcome metrics include the number of words or objects recalled across trials and the delayed recall score, expressed in standard scores and percentile ranks.
Time frame: 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.
Visual-Motor Integration
Assessed using the Test of Visual Motor Integration (VMI), which evaluates the coordination between visual perception and motor function. It consists of 3 components: Visual Motor Integration, requiring participants to copy increasingly complex forms; Visual Perception, involving the identification of matching forms among distractors; and Fine Motor Coordination, assessing precision in connecting dots within defined boundaries. The outcome includes raw scores converted to standard scores, with a mean of 100 and a standard deviation of 15, as well as percentile ranks.
Time frame: 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.
Gross and Fine Motor Skills
Measured using the Movement Assessment Battery for Children-2 (MABC-2), which evaluates motor skills through 3 components: Manual Dexterity, assessing fine motor control; Aiming and Catching, measuring coordination between fine and gross motor movements; and Balance, which examines static and dynamic postural control through structured physical tasks. The outcomes are expressed as standard scores (mean = 100, SD = 15) and percentile ranks.
Time frame: 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.
Short-Term Memory
Evaluated using the Battery for Neuropsychological Evaluation of Children Battery (BVN 5-11), including the Digit Span and Corsi Block-Tapping Tests. The Digit Span Test requires participants to repeat sequences of numbers in the same or reversed order, assessing verbal short-term memory. The Corsi Block-Tapping Test involves replicating sequences of tapped blocks to assess visuo-spatial short-term memory. The score is determined by the number of items correctly recalled, expressed as Z-scores based on a normative sample, where a Z-score of 0 indicates the average performance of the normative group.
Time frame: 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.
Behavioral and Emotional Symptoms
Assessed using the Child Behavior Checklist for Ages 6-18 (CBCL 6-18), a standardized parent-report questionnaire, comprised of 8 syndrome scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behaviour, and aggressive behaviour), 3 broadband scores (internalizing and externalizing problems, and total problem), Diagnostic and Statistical Manual of mental disorders (DSM)-oriented scales (affective problems, anxiety problems, somatic problems, attention deficit/hyperactivity problem, oppositional defiant problems, conduct problems), and the 2007 Scales (sluggish cognitive tempo, obsessive-compulsive problems, post-traumatic stress problems). For each subscale raw scores will be converted in T-scores (M = 50, SD = 10).
Time frame: 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.
Ankle Dorsiflexion
Ankle dorsiflexion will be evaluated using the Knee to Wall test, in which the participant places one foot touching the wall and gradually moves back until being able to touch the wall with the knee while keeping the heel on the ground.
Time frame: 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.
Joint Mobility
Joint mobility will be assessed through a Scapular-Humeral Circumduction test, conducted with a calibrated stick, where the result is the last completed circumduction with extended arms.
Time frame: 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.
Trunk Strength
Trunk strength will be assessed using the Trunk Lift test, in which participants lie prone on a mat and lift their upper body off the floor to their maximum height. The distance between the floor and the participant's chin will be measured.
Time frame: 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.
Flexibility: Sit and Reach Test
In the Sit and Reach test, participants sit with their legs extended and feet dorsiflexed against a 30 cm support, then perform a forward trunk flexion. The result is measured as the distance between the fingertips and the toes.
Time frame: 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.
Flexibility: Lateral Trunk Flexion Test
Flexibility will also be assessed using the Lateral Trunk Flexion test, which records the difference between the initial hand position and the maximum lateral flexion.
Time frame: 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.
Quality of Life: Physical, Emotional, Social, and School Functioning
The Pediatric Quality of Life Inventory (PedsQL version 4) is a widely used tool in studies involving children with obesity to measure key dimensions of health and quality of life. It includes domains of Physical, Emotional, Social, and School Functioning. Both child self-report and parent-report formats will be administered. Total Score and Psychosocial Health Summary Score will be calculated as percentages. Higher percentages indicate better functioning across these domains.
Time frame: 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.
Social Adaptive Skills
The social skill domain will be investigated through the standardized parent-reported Adaptive Behavior Assessment System, Second Edition (ABAS-II), which will provide the Social Adaptive Composite (SAC), which summarizes performance across the Leisure and Social skill areas. Raw scores will be converted into standardized weighted scores (M = 10, SD = 3) and standard scores (M = 100, SD = 15).
Time frame: 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.
Social Skills
The Social Responsiveness Scale (SRS) will be used as well. The SRS is a standardized parent-report measure frequently used with children and adolescents between the ages of 4 and 18 years to screen subtle social communication deficits. The SRS generates 5 subscales: social awareness, social cognition, social motivation and social communication. Raw scores will be converted to gender-normed T-scores (M = 50, SD = 10).
Time frame: 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.
Eating Behavior and Disorders
The Eating Disorders Questionnaire in Childhood (EDQ-C) is a standardized tool used for the early identification of eating disorders in children, assessing comorbidities with attachment patterns, anxiety and mood disorders, as well as relational and behavioural difficulties. It includes a self-report version for children aged 8 and older, and 2 parent-report forms based on the child's age (4-7 and 8-12 years). For each diagnostic category, raw scores will be calculated and converted into standard score and percentile ranks (\< 90 = within normal range, \> 95 = clinically significant, \> 99 = pathological).
Time frame: 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.
Sleep Habits and Quality
To assess sleep habits and quality, the Sleep Disturbance Scale for Children (SDSC) will be employed. This standardized parent-report questionnaire evaluates various aspects of children's sleep, including duration, onset time, sleep disorders and an overall measure of sleep disturbances in children and adolescents aged 6 to 15 years. Six main areas are investigated by the following subscales: Disorders in Initiating and Maintaining Sleep (DIMS), Sleep Breathing Disorders (SBD), Arousal Disorders (DA), Sleep-Wake Transition Disorders (SWTD), Excessive Sleepiness (DES), and Nocturnal Hyperhidrosis (NH). For each subscale raw scores will be converted in T-scores (M = 50, SD = 10).
Time frame: 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.
Brain Function
Brain responses will be studied through vascular brain activity to a glucose challenge, measured using functional near-infrared spectroscopy (fNIRS) in children and functional MRI (fMRI) in adults.
Time frame: 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.
Plasma Analysis
Plasma samples will be analysed for circulating levels of adipokines and cytokines (R\&D Systems, Inc. 614 McKinley Place NE Minneapolis, MN 55413), including Brain-Derived Neurotrophic Factor (BDNF), a key regulator of neural plasticity and appetite suppression, Pro-OpioMelanoCortin (POMC) and its derivative Melanocyte-Stimulating Hormone (MSH), which play a central role in the anorectic response to leptin, eotaxin/CCL11, a proinflammatory chemokine linked to age-related cognitive decline, and Insulin-like Growth Factor-Binding Protein 2 (IGFBP2), a liver-derived protein regulated by leptin and involved in glucose homeostasis.
Time frame: 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.
Gut Microbioma
The composition of the gut microbiota will be assessed using genomic analysis of stool samples collected from participants. Fresh stool samples will be collected by participants at home, immediately frozen at approximately -20°C, and transported in a refrigerated box to the biobank. Upon arrival, the samples will be stored at -80°C until DNA extraction.
Time frame: 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.
Muscle Strength: Upper Limb Strength
Upper limb strength will be evaluated with a Floor Press test using calibrated dumbbells based on each participant's strength.
Time frame: 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.
Muscle Strength: Handgrip Strength
Handgrip strength will be assessed using a dynamometer.
Time frame: 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.
Lower Limb Explosive Strength
Lower limb explosive strength will be measured with the Standing Long Jump test, where participants jump as far as possible, landing with both feet together; the best of two attempts will be considered.
Time frame: 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.
Abdominal Strength and Endurance
Abdominal strength and endurance will be assessed with a Sit-Up test, where participants lie supine with their legs bent at 90° and perform sit-ups, with the result being the maximum number of repetitions performed.
Time frame: 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.
Balance
Balance will be assessed using the Single Leg Stance test, where participants maintain a single-leg stance within a shoe-sized rectangle for 60 seconds, with the number of falls recorded.
Time frame: 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.
Plan to share: Yes — Data will be shared upon reasonable request, subject to validation by the OPBG Ethics Committee, in compliance with GDPR and European regulations. Alternatively, aggregated data may be considered.
Supporting information: Study protocol
Time frame: The time frame for data availability will be determined in accordance with GDPR and relevant European regulations.
Access criteria: Access to the IPD and supporting information will be granted to the Principal Investigator (PI) of the research, Dr. Melania Manco (melania.manco@opbg.net).
Data sharing details ↗ · www.ospedalebambinogesu.it
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Bambino Gesù Hospital and Research Institute