Last reviewed · How we verify
NCT04335799: RESET
Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools
NA trial testing Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training in Obesity in 341 participants. Participants enrolled and being followed up; not accepting new ones.
31 March 2026
Quick facts
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 341 |
| Start date | 12 October 2021 |
| Primary completion | 31 March 2026 |
| Estimated completion | 31 March 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training
- Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics
Conditions studied
- Obesity — all drugs for Obesity →
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Who can join
Adults 21 to 75, female only, with Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this protocol is to test the effects on weight of an evidence-based behavioral weight loss program enhanced with culturally targeted stress management strategies compared to the evidence-based weight loss program alone among adult black females with obesity and elevated stress levels. Participants will be randomized to receive either a behavioral weight loss intervention with a focus on stress management or the weight loss intervention alone for 26 sessions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04335799
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04335799 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
- Last refreshed: 27 February 2026
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/NCT04335799.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing