Last reviewed · How we verify
NCT03372018: PRIME2
Promotora-Led Intervention for Metabolic and Mental Health
NA trial testing Promotora-led Intervention (PLI) in PreDiabetes in 53 participants. Completed in 22 March 2019.
22 March 2019
Quick facts
| Lead sponsor | Northwestern University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 7 August 2018 |
| Primary completion | 22 March 2019 |
| Estimated completion | 22 March 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Promotora-led Intervention (PLI)
- Usual care (UC)
Conditions studied
- PreDiabetes — all drugs for PreDiabetes →
- Obesity — all drugs for Obesity →
- Metabolic Disease — all drugs for Metabolic Disease →
- Body Weight Changes — all drugs for Body Weight Changes →
Sponsor
Northwestern University
Who can join
18 and older, any sex, with PreDiabetes or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Evidence-based programs to prevent diabetes among high-risk individuals are less effective among those who also have mental health needs. This study involves developing and pilot testing the first adaptation of the landmark Diabetes Prevention Program lifestyle intervention to simultaneously treat prediabetes and elevated mental health symptoms. This project has large potential to impact public health, given that more than half of the U.S. adult population has either of these conditions, and is at risk for developing comorbid diabetes and mental illness.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Promotora intervention for metabolic and mental health to reduce type 2 diabetes risk: a pilot randomized controlled trial.
Vargas MC, Katz JB, Lopez A, Carrillo A, et al · · 2024 · PMID 39738452 · DOI 10.1038/s41598-024-83482-5
Verify or expand the search:
- PubMed search for NCT03372018
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for PreDiabetes
Currently open trials in the same condition.
- NCT06897982 — Feasibility of a Nutrition Intervention for Patients With Prediabetes at a Federally Qualified Health Center · NA · recruiting
- NCT06967558 — The Role of Islet GLP-1 in the Pathogenesis of Prediabetes · Phase 2 · recruiting
- NCT06482944 — Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes · NA · recruiting
- NCT06989164 — Post Prandial Individual Responses to Different Foods · NA · recruiting
- NCT07254572 — Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes · Phase 4 · recruiting
Other Northwestern University trials
Trials by the same sponsor.
- NCT06545695 — Epidermal Growth Factor Receptor Inhibition for Keratinopathies · Phase 1, PHASE2 · not yet recruiting
- NCT07261657 — N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive C · EARLY_PHASE1 · not yet recruiting
- NCT07392775 — ALDH2 Genetic Testing in East Asian Community · NA · not yet recruiting
- NCT06886776 — Implementing A Secure Firearm Storage Program in Illinois Health Centers in Partnership With AllianceChicago and the Ill · NA · not yet recruiting
- NCT07469176 — Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With · NA · not yet recruiting
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 NCT03372018 (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 Northwestern University
- Last refreshed: 5 June 2019
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/NCT03372018.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing