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Assessment of an Intervention to Prevent Obesity and Diabetes in Latino Farm Workers (Pasos)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Diabetes Type II,, Overweight,, Obesity,, Behavioral Intervention,, Latino, farm worker, randomized controlled intervention

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 18 -60
  • BMI between 20 -38
  • Willing to attend 10 weekly education sessions
  • Able to speak and understand Spanish
  • Have medical insurance

Exclusion Criteria:

  • Fasting blood glucose about 126mg/dL unless physician attests fit to participate
  • Pregnancy or trying to conceive, or breastfeeding
  • Diabetic
  • On therapeutic diets
  • On medications that affect weight
  • If spouse / cohabitant already in the study
  • Not a farm worker working for the Reiter Affiliated Companies

Sites / Locations

  • Reiter Affiliated Companies
  • Reiter Affiliated Companies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral intervention

Control

Arm Description

Behavioral intervention consisting of 10 educational sessions promoting healthy diet and increased physical activity.

Control arm received no behavioral intervention

Outcomes

Primary Outcome Measures

Change in BMI
Weight and Height assessed for both control and intervention participants before intervention program and then assessed 2-3 weeks after the intervention period completed.

Secondary Outcome Measures

Change in Waist Circumference
Waist circumference measured in both control and intervention participants using a standard protocol. Conducted before intervention started and again 2-3 weeks after the intervention sessions finished.

Full Information

First Posted
May 8, 2013
Last Updated
May 11, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01855282
Brief Title
Assessment of an Intervention to Prevent Obesity and Diabetes in Latino Farm Workers
Acronym
Pasos
Official Title
Pasos Saludables: A Pilot Intervention to Prevent Obesity and Diabetes Among Latino Farm Workers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a study 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. Workers enrolled in a 2:1 ratio by random allocation into an intervention or control arm of the study. The intervention participants received weekly classes for 10 weeks with education on diabetes, diet and physical activity and practical exercises. Both control and intervention were measured for weight, waist circumference, fasting blood glucose and interviewed before and after the study intervention. The main hypothesis was that intervention, but not control participants, would experience reduction in body measurements after the intervention.
Detailed Description
A more detailed description is not desired as noted above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Diabetes Type II,, Overweight,, Obesity,, Behavioral Intervention,, Latino, farm worker, randomized controlled intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral intervention
Arm Type
Experimental
Arm Description
Behavioral intervention consisting of 10 educational sessions promoting healthy diet and increased physical activity.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control arm received no 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 attended up to 10 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions were conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support were 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.
Primary Outcome Measure Information:
Title
Change in BMI
Description
Weight and Height assessed for both control and intervention participants before intervention program and then assessed 2-3 weeks after the intervention period completed.
Time Frame
Before intervention and after (12-14 weeks after first assessment)
Secondary Outcome Measure Information:
Title
Change in Waist Circumference
Description
Waist circumference measured in both control and intervention participants using a standard protocol. Conducted before intervention started and again 2-3 weeks after the intervention sessions finished.
Time Frame
Measured before and after intervention (12 - 13 weeks after first assessment
Other Pre-specified Outcome Measures:
Title
Change in fasting blood glucose
Description
Fasting blood glucose was a voluntary assessment and therefore not conducted in all participants. Blood glucose was assessed from a middle digit using a sterile lancet and Accu-Check Advantage Blood Glucose Meter. It was assessed before the start of the intervention and after completion in both controls and intervention participants.
Time Frame
Measured before intervention and after (12-13 weeks after first assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 -60 BMI between 20 -38 Willing to attend 10 weekly education sessions Able to speak and understand Spanish Have medical insurance Exclusion Criteria: Fasting blood glucose about 126mg/dL unless physician attests fit to participate Pregnancy or trying to conceive, or breastfeeding Diabetic On therapeutic diets On medications that affect weight If spouse / cohabitant already in the study Not a farm worker working for the Reiter Affiliated Companies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc B Schenker, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reiter Affiliated Companies
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Reiter Affiliated Companies
City
Watsonville
State/Province
California
ZIP/Postal Code
95076
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26461858
Citation
Mitchell DC, Andrews T, Schenker MB. Pasos Saludables: A Pilot Randomized Intervention Study to Reduce Obesity in an Immigrant Farmworker Population. J Occup Environ Med. 2015 Oct;57(10):1039-46. doi: 10.1097/JOM.0000000000000535.
Results Reference
derived

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Assessment of an Intervention to Prevent Obesity and Diabetes in Latino Farm Workers

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