Clinical trial NCT02480244: PASOS: Improving the Health of Immigrant Workers
Official title: Translating Obesity and Diabetes Prevention Into the Worksite for Immigrant Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Diabetes
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-06-24
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in BMI
timeFrame: 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 outcomes:
measure: Change in waist circumference
timeFrame: 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.
measure: Change in hemoglobin A1c (HbA1c)
timeFrame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
measure: Change in cholesterol
timeFrame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
measure: Change in behavior and lifestyle factors
timeFrame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
measure: Cost analysis
timeFrame: Quarterly beginning a year prior to implementation of the intervention and concluding 1.5 years post-intervention.
measure: Change in blood pressure
timeFrame: 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.
Other outcomes:
Locations:
city: Oxnard
country: United States
facility: Reiter Brothers Inc.
state: California
Study officials:
affiliation: University of California, Davis
name: Marc Schenker, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borelli MR, Riden HE, Bang H, Schenker MB. Protocol for a cluster randomized controlled trial to study the effectiveness of an obesity and diabetes intervention (PASOS) in an immigrant farmworker population. BMC Public Health. 2018 Jul 9;18(1):849. doi: 10.1186/s12889-018-5560-0.