PASOS: Improving the Health of Immigrant Workers

Not Applicable

Completed

• Conditions: Diabetes; Overweight and Obesity
• Interventions: Behavioral: Behavioral Intervention; Other: Control

• Registration Number: NCT02480244
• Lead Sponsor: University of California, Davis

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-24
• Study Start: 2015-07
• Primary Completion: 2018-10-02
• Study Completion: 2018-10-02
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-05
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 554

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral intervention	Behavioral Intervention	Behavioral intervention consisting of 12 educational sessions promoting healthy diet and increased physical activity
Control	Control	Control arm receives no health-related behavioral intervention

Primary Outcome Measures

Name	Time	Method
Change in BMI	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

Name	Time	Method
Change in hemoglobin A1c (HbA1c)	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.
Cost analysis	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 cholesterol	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	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.
Change in waist circumference	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 blood pressure	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.

Trial Locations

Locations (1)

Reiter Brothers Inc.; 🇺🇸 Oxnard, California, United States