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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

TypeNameDescription
BEHAVIORALBehavioral InterventionIntervention 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.
OTHERControlControl 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.