Reprogramming Energy Homeostasis in Overweight Individuals Via Exercise, Cognitive, and Social Training
NCT ID: NCT06931730
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2024-02-08
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Intensive Health Behavior Treatment group: Physical Activity and Diet
Participants will be provided with a personalized dietary plan and a Physical Activity training
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.
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.
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.
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.
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.
Cognitive training
Participants will undergo an online cognitive training program, with a particular focus on memory enhancement.
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.
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.
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.
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.
Interventions
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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.
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.
Cognitive training
Participants will undergo an online cognitive training program, with a particular focus on memory enhancement.
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.
Eligibility Criteria
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Inclusion Criteria
* Intelligence Quotient (IQ) ≥ 85
Exclusion Criteria
* reduced mobility;
* systemic diseases;
* ongoing pharmacological treatment for chronic conditions.
6 Years
11 Years
ALL
No
Sponsors
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Bambino Gesù Hospital and Research Institute
OTHER
Responsible Party
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Melania Manco
Medical Director, Preventive and Predictive Medicine
Locations
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Ospedale Pediatrico Bambino Gesù
Rome, Italy, Italy
Bambino Gesù Hospital and Research Institute,
Rome, Rome, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Russo V, Menghini D, Mainardi M, Fintini D, Aureli A, Gianni N, Rava L, Rea MA, Scozia G, Spiezia C, Scabia G, Furini G, Vicari S, Cianfarani S, Maffei M, Manco M. Reprogramming energy homeostasis in children with overweight through cognitive training and social interaction. A study protocol to estimate leptin sensitivity. Front Endocrinol (Lausanne). 2025 Jun 18;16:1606132. doi: 10.3389/fendo.2025.1606132. eCollection 2025.
Other Identifiers
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PNRR-MAD-2022-12376459
Identifier Type: -
Identifier Source: org_study_id
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