N/A
N=683
Health-Smart for Weight Loss at UF Jax Clinics
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03418701 ↗Enrolled (actual)
683
Serious AEs
0.5%
Results posted
Oct 2024
Primary outcome: Primary: Weight Loss — 24.04 percent who lost 5% or more weight — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Health Smart for Weight Loss (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- University of Florida
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Loss |
24.04 | <0.05 sig |
| PRIMARY Weight Loss Maintenance |
34.63; 29.48 | <0.05 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- African American/black
- Female
- Age 21 years or older
- BMI range ≥ 30kg/m2 (5) active patient of a participating clinic (i.e., at least 2 clinic visits in the last 24 months)
- Willing and ready to change one's diet and physical activity level
- Willing to be randomized to either of the two weight-loss maintenance intervention groups
Exclusion Criteria
- Any serious medical condition that likely affects weight, such as end stage renal disease or cancer
- Prior bariatric surgery within the last 5 years or plans for this surgery in the next 2 years
- Use of prescription or over-the-counter weight-loss medication within the last 6 months
- Pregnant or plan to get pregnant within the next 2 years
- Plan to relocate from the area within the next 2 years
- Having had unintentional weight loss (>or = to 5% of body weight) within 6 months prior to enrollment
- Taking a daily dose of oral corticosteroid antipsychotic (clozapine, olanzapine, or risperidone) for less than 6 months
Data sourced from ClinicalTrials.gov (NCT03418701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.