PASOS: Improving the Health of Immigrant Workers

August 5, 2020 updated by: University of California, Davis

Translating Obesity and Diabetes Prevention Into the Worksite for Immigrant Populations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

554

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oxnard, California, United States, 93030
        • Reiter Brothers Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Work at Reiter Brothers Inc. (RBI), a partner, or affiliate company
  • Able to speak and understand Spanish
  • Willing to attend weekly sessions for length of intervention
  • Plan to stay in the area for the next three months

Exclusion Criteria:

  • Workers without Spanish language comprehension
  • Pregnant women and those planning a pregnancy within six months
  • Women who are breastfeeding, unless discontinuing breastfeeding within one month
  • Individuals who, without health care provider approval, are: unable to undertake moderate physical exercise, taking medicine for high blood pressure or heart conditions, have bone or joint problems, lose consciousness or fall due to dizziness, or have developed chest pain within the last month
  • Individuals taking medications that affect weight
  • Individuals with therapeutic diets
  • Diabetic status determined by health care professional after HbA1c testing result is >6.5%
  • If spouse / cohabitant is already in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral intervention
Behavioral intervention consisting of 12 educational sessions promoting healthy diet and increased physical activity
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 Names:
  • Healthy Lifestyle intervention
  • Diet and Physical Activity intervention
Active Comparator: Control
Control arm receives no health-related behavioral intervention
Other: Control
Control arm receives no health-related behavioral intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI
Time Frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.
Weight and height will be assessed at each data collection point and concurrently for control and intervention participants on matched ranches.
Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in waist circumference
Time Frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.
Waist circumference will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.
Change in hemoglobin A1c (HbA1c)
Time Frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
HbA1c will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
Change in cholesterol
Time Frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
Cholesterol will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
Change in behavior and lifestyle factors
Time Frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
Change in behavior and lifestyle factors will be assessed concurrently for control and intervention participants on matched ranches using a questionnaire comprised of validated measures.
Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
Cost analysis
Time Frame: Quarterly beginning a year prior to implementation of the intervention and concluding 1.5 years post-intervention.
Assessment of intervention's impact on employer costs.
Quarterly beginning a year prior to implementation of the intervention and concluding 1.5 years post-intervention.
Change in blood pressure
Time Frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.
Change in blood pressure will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

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

Investigators

  • Principal Investigator: Marc Schenker, MD, MPH, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

October 2, 2018

Study Completion (Actual)

October 2, 2018

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 575576
  • R18DK096429 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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