Last reviewed · How we verify
NCT06931730: Resilient
Reprogramming Energy Homeostasis in Overweight Individuals Via Exercise, Cognitive, and Social Training
NA trial testing Nutritional Intervention in Obesity and Overweight in 240 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Bambino Gesù Hospital and Research Institute |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 8 February 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- Nutritional Intervention
- Physical Activity training
- Cognitive training
- Social Training
Conditions studied
- Obesity and Overweight — all drugs for Obesity and Overweight →
- Leptin Resistance — all drugs for Leptin Resistance →
- Childhood Obesity — all drugs for Childhood Obesity →
Sponsor
Bambino Gesù Hospital and Research Institute
Who can join
Adults 6 to 11, any sex, with Obesity and Overweight or Leptin Resistance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Reprogramming energy homeostasis in children with overweight through cognitive training and social interaction. A study protocol to estimate leptin sensitivity.
Russo V, Menghini D, Mainardi M, Fintini D, et al · · 2025 · PMID 40607230 · DOI 10.3389/fendo.2025.1606132
Verify or expand the search:
- PubMed search for NCT06931730
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Bambino Gesù Hospital and Research Institute trials
Trials by the same sponsor.
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- NCT06080191 — Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed/Refractory B-ALL · Phase 1 · recruiting
- NCT06064903 — CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL · Phase 1, PHASE2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06931730 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bambino Gesù Hospital and Research Institute
- Last refreshed: 17 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06931730.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing