PASOS: Improving the Health of Immigrant Workers

Diabetes Clinical Trial

Official title:

Translating Obesity and Diabetes Prevention Into the Worksite for Immigrant Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480244
• Other study ID #: 575576
• Secondary ID: R18DK096429
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: October 2, 2018

Study information

• Verified date: August 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: October 2, 2018
• Est. primary completion date: October 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Behavioral Intervention
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.

Other:
• Control
Control arm receives no health-related behavioral intervention

Locations

Country	Name	City	State
United States	Reiter Brothers Inc.	Oxnard	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.