Trials / Completed
CompletedNCT02480244
PASOS: Improving the Health of Immigrant Workers
Translating Obesity and Diabetes Prevention Into the Worksite for Immigrant Populations
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 554 (actual)
- Sponsor
- University of California, Davis · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a cluster randomized trial (CRT) to assess the effectiveness of a culturally appropriate behavioral intervention to reduce obesity levels and ultimately the risk of developing diabetes type II in immigrant Latino farm workers. Randomization is at the farm ranch level. Individuals at intervention ranches will receive a multi-week curriculum at the work-site on diabetes, diet and physical activity and optional supplemental sessions in the evening and weekends. The investigators will adopt the intent-to-treat principle for the primary analysis. Individuals on control ranches will receive no health educational instruction. The primary outcome is BMI. The investigators hypothesize that intervention ranches will achieve significant improvement in obesity and diabetes risk factors as compared to control ranches.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Behavioral Intervention | Intervention participants attend up to 12 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions are conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support are also emphasized. The control participants like the intervention were measured and interviewed before and again after the intervention sessions, but received no educational instruction or materials. |
| OTHER | Control | Control arm receives no health-related behavioral intervention |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2018-10-02
- Completion
- 2018-10-02
- First posted
- 2015-06-24
- Last updated
- 2020-08-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02480244. Inclusion in this directory is not an endorsement.