Improving energy balance in overweight individuals through exercise and cognitive training
Reprogramming Energy Homeostasis in Overweight Children and Adults Trough Exercise, Cognitive Training and Social Interaction
This study is testing if combining exercise with mental and social training can help overweight people, including kids, feel more satisfied with their food and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 6 Years to 11 Years |
| Sex | All |
| Sponsor | Bambino Gesù Hospital and Research Institute Academic / other |
| Locations | 2 sites (Rome, Italy and 1 other locations) |
| Trial ID | NCT06931730 on ClinicalTrials.gov |
What this trial studies
The RESILIENT project investigates how cognitive and social training can enhance leptin sensitivity in overweight individuals, including children. Participants will undergo an 8-week intervention that combines Intensive Health Behaviour Treatment with cognitive and social training, followed by a 12-week washout period. The study will assess leptin sensitivity through various methods, including measuring leptin levels in relation to caloric intake and analyzing leptin signaling in blood cells. Additionally, clinical, psychological, cognitive, and physiological evaluations will be conducted to determine the effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates are individuals with overweight or obesity and an IQ of 85 or higher.
Not a fit: Patients with genetic or syndromic obesity, reduced mobility, systemic diseases, or those on chronic pharmacological treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for obesity and related metabolic disorders.
How similar studies have performed: While the specific combination of cognitive and social training with metabolic assessments is novel, similar studies have shown promise in improving obesity-related outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome, Italy and 1 other locations
- Ospedale Pediatrico Bambino Gesù — Rome, Italy, Italy (Recruiting)
- Bambino Gesù Hospital and Research Institute, — Rome, Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Melania Manco
- Email: melania.manco@opbg.net
- Phone: +39 3317775547
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.