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PASOS: Improving the Health of Immigrant Workers

This study is currently recruiting participants.
Verified May 2017 by University of California, Davis
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480244
First Posted: June 24, 2015
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of California, Davis
  Purpose
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.

Condition Intervention
Overweight and Obesity Diabetes Behavioral: Behavioral Intervention Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Translating Obesity and Diabetes Prevention Into the Worksite for Immigrant Populations

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 600
Study Start Date: July 2015
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480244


Contacts
Contact: Heather E Riden, MA 530-752-1689 heriden@ucdavis.edu

Locations
United States, California
Reiter Brothers Inc. Recruiting
Oxnard, California, United States, 93030
Contact: Jose Gutierrez       jose.gutierrez@berry.net   
Sponsors and Collaborators
University of California, Davis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Marc Schenker, MD, MPH University of California, Davis
  More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02480244     History of Changes
Other Study ID Numbers: 096429
R18DK096429 ( U.S. NIH Grant/Contract )
First Submitted: June 9, 2015
First Posted: June 24, 2015
Last Update Posted: May 30, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms