PASOS: Improving the Health of Immigrant Workers

University of California (UC) Davis

Status: Completed

Conditions: Diabetes; Overweight and Obesity

Treatments: Other: Control; Behavioral: Behavioral Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02480244

575576

R18DK096429 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 554 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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554 participants in 2 patient groups

Behavioral intervention

Experimental group

Description:

Behavioral intervention consisting of 12 educational sessions promoting healthy diet and increased physical activity

Treatment:

Behavioral: Behavioral Intervention

Control

Active Comparator group

Description:

Control arm receives no health-related behavioral intervention

Treatment:

Other: Control