Assessment of an Intervention to Prevent Obesity and Diabetes in Latino Farm Workers

Study Overview
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Brief Summary
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This is a study 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. Workers enrolled in a 2:1 ratio by random allocation into an intervention or control arm of the study. The intervention participants received weekly classes for 10 weeks with education on diabetes, diet and physical activity and practical exercises. Both control and intervention were measured for weight, waist circumference, fasting blood glucose and interviewed before and after the study intervention. The main hypothesis was that intervention, but not control participants, would experience reduction in body measurements after the intervention.

Detailed Description
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A more detailed description is not desired as noted above.

Official Title
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Pasos Saludables: A Pilot Intervention to Prevent Obesity and Diabetes Among Latino Farm Workers

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Behavioral Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 -60 BMI between 20 -38 Willing to attend 10 weekly education sessions Able to speak and understand Spanish Have medical insurance Exclusion Criteria: Fasting blood glucose about 126mg/dL unless physician attests fit to participate Pregnancy or trying to conceive, or breastfeeding Diabetic On therapeutic diets On medications that affect weight If spouse / cohabitant already in the study Not a farm worker working for the Reiter Affiliated Companies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral intervention<br>Behavioral intervention consisting of 10 educational sessions promoting healthy diet and increased physical activity. | Behavioral: Behavioral Intervention<br>* Intervention participants attended up to 10 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions were conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support were 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 received no behavioral intervention | Behavioral: Behavioral Intervention<br>* Intervention participants attended up to 10 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions were conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support were 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;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI | Weight and Height assessed for both control and intervention participants before intervention program and then assessed 2-3 weeks after the intervention period completed. | Before intervention and after (12-14 weeks after first assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Waist Circumference | Waist circumference measured in both control and intervention participants using a standard protocol. Conducted before intervention started and again 2-3 weeks after the intervention sessions finished. | Measured before and after intervention (12 - 13 weeks after first assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Type II,, Overweight,, Obesity,, Behavioral Intervention,, Latino, farm worker, randomized controlled intervention