Back to resultsPASOS: Improving the Health of Immigrant Workers
Primary Purpose
Overweight and Obesity, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Control
Sponsored by
About this trial
This is an interventional prevention trial for Overweight and Obesity
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
Sites / Locations
- Reiter Brothers Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Behavioral intervention
Control
Arm Description
Behavioral intervention consisting of 12 educational sessions promoting healthy diet and increased physical activity
Control arm receives no health-related behavioral intervention
Outcomes
Primary Outcome Measures
Change in BMI
Weight and height will be assessed at each data collection point and concurrently for control and intervention participants on matched ranches.
Secondary Outcome Measures
Change in waist circumference
Waist circumference will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
Change in hemoglobin A1c (HbA1c)
HbA1c will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
Change in cholesterol
Cholesterol will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
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.
Cost analysis
Assessment of intervention's impact on employer costs.
Change in blood pressure
Change in blood pressure will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
Full Information
NCT ID
NCT02480244
First Posted
June 9, 2015
Last Updated
August 5, 2020
Sponsor
University of California, Davis
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02480244
Brief Title
PASOS: Improving the Health of Immigrant Workers
Official Title
Translating Obesity and Diabetes Prevention Into the Worksite for Immigrant Populations
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
October 2, 2018 (Actual)
Study Completion Date
October 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
554 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral intervention
Arm Type
Experimental
Arm Description
Behavioral intervention consisting of 12 educational sessions promoting healthy diet and increased physical activity
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control arm receives no health-related behavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Healthy Lifestyle intervention, Diet and Physical Activity intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Control arm receives no health-related behavioral intervention
Primary Outcome Measure Information:
Title
Change in BMI
Description
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.
Secondary Outcome Measure Information:
Title
Change in waist circumference
Description
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.
Title
Change in hemoglobin A1c (HbA1c)
Description
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.
Title
Change in cholesterol
Description
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.
Title
Change in behavior and lifestyle factors
Description
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.
Title
Cost analysis
Description
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.
Title
Change in blood pressure
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Schenker, MD, MPH
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reiter Brothers Inc.
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29986676
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.
Results Reference
derived
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PASOS: Improving the Health of Immigrant Workers
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