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PASOS: Improving the Health of Immigrant Workers

NCT02480244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 554

Last updated 2020-08-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Marc Schenker, MD, MPH · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-10-02
Completion
2018-10-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02480244 on ClinicalTrials.gov