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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
554
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.
Control arm receives no health-related behavioral intervention
Reiter Brothers Inc.
Oxnard, California, United States
Change in BMI
Weight and height will be assessed at each data collection point and concurrently for control and intervention participants on matched ranches.
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 waist circumference
Waist circumference will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
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 hemoglobin A1c (HbA1c)
HbA1c will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
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 cholesterol
Cholesterol will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
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
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.
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.
Cost analysis
Assessment of intervention's impact on employer costs.
Time frame: 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.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.