PASOS: Improving the Health of Immigrant Workers

Study Overview
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Brief Summary
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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.

Official Title
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Translating Obesity and Diabetes Prevention Into the Worksite for Immigrant Populations

Conditions
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Overweight and Obesity, Diabetes

Intervention / Treatment
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* Behavioral: Behavioral Intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral intervention<br>Behavioral intervention consisting of 12 educational sessions promoting healthy diet and increased physical activity | Behavioral: Behavioral Intervention<br>* 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.<br>* Other names: Diet and Physical Activity intervention;|
| Active Comparator: Control<br>Control arm receives no health-related behavioral intervention | Other: Control<br>* Control arm receives no health-related behavioral intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI | 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 | 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) | 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 | 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 | 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 | 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 | 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. |