PASOS: Improving the Health of Immigrant Workers
Translating Obesity and Diabetes Prevention Into the Worksite for Immigrant Populations
2 other identifiers
interventional
554
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2018
CompletedAugust 7, 2020
August 1, 2020
3.3 years
June 9, 2015
August 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Change in waist circumference
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)
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
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
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
Quarterly beginning a year prior to implementation of the intervention and concluding 1.5 years post-intervention.
- +1 more secondary outcomes
Study Arms (2)
Behavioral intervention
EXPERIMENTALBehavioral intervention consisting of 12 educational sessions promoting healthy diet and increased physical activity
Control
ACTIVE COMPARATORControl arm receives no health-related behavioral intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reiter Brothers Inc.
Oxnard, California, 93030, United States
Related Publications (1)
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.
PMID: 29986676DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Schenker, MD, MPH
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2015
First Posted
June 24, 2015
Study Start
July 1, 2015
Primary Completion
October 2, 2018
Study Completion
October 2, 2018
Last Updated
August 7, 2020
Record last verified: 2020-08