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Health-Smart for Weight Loss at UF Jax Clinics
NA trial testing Health Smart for Weight Loss in Obesity in 683 participants. Completed in 31 July 2022.
| Lead sponsor | University of Florida |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 683 |
| Start date | 1 April 2018 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 July 2022 |
| Sites | 1 location across United States |
University of Florida
Adults 21 to 100, female only, with Obesity. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
percentage of participating patients who show clinically significant weight loss (i.e., at least 5% of baseline body weight)
| Group | Value | 95% CI |
|---|---|---|
| 6-month CHW-implemented HSWL Program | 24.04 | 19.3 – 29.4 |
percentage of participants will maintain initial weight loss or show continued weight loss
| Group | Value | 95% CI |
|---|---|---|
| Patient Centered Culturally Sensitive WLM | 34.63 | 25.8 – 44.2 |
| Standard Behavioral WLM | 29.48 | 21.9 – 37.5 |
Time frame: 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 6-month CHW-implemented HS… | Patient Centered Culturall… | Standard Behavioral WLM |
|---|---|---|---|---|
| back surgery | Musculoskeletal and connective tissue disorders | — | — | — |
| knee arthroplasty | Musculoskeletal and connective tissue disorders | — | — | — |
| ankle fracture | Musculoskeletal and connective tissue disorders | — | — | — |
| nephrostolithotomy surgery | Hepatobiliary disorders | — | — | — |
| chest pain | Cardiac disorders | — | — | — |
| Reaction | System | 6-month CHW-implemented HS… | Patient Centered Culturall… | Standard Behavioral WLM |
|---|---|---|---|---|
| motor vehicle accident with minor injuries | Musculoskeletal and connective tissue disorders | — | — | — |
| Fell in store parking lot | Injury, poisoning and procedural complications | — | — | — |
| cyst drainage | Infections and infestations | — | — | — |
Most-reported serious reactions: back surgery, knee arthroplasty, ankle fracture, nephrostolithotomy surgery, chest pain.
Data from ClinicalTrials.gov NCT03418701 adverse events section.
The study will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program is being implemented by Community Health Workers at the primary care centers and followed by either of two physician-implemented behavioral counseling programs to prevent weight gain--programs that are implemented quarterly over 12 months.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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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/NCT03418701.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing