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

May 11, 2017 updated by: University of California, Davis

Pasos Saludables: A Pilot Intervention to Prevent Obesity and Diabetes Among Latino Farm Workers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A more detailed description is not desired as noted above.

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oxnard, California, United States, 93030
        • Reiter Affiliated Companies
      • Watsonville, California, United States, 95076
        • Reiter Affiliated Companies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral intervention
Behavioral intervention consisting of 10 educational sessions promoting healthy diet and increased physical activity.
Behavioral: Behavioral Intervention
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.
Other Names:
  • Healthy Lifestyle intervention
  • Diet and Physical Activity intervention
Active Comparator: Control
Control arm received no behavioral intervention
Behavioral: Behavioral Intervention
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.
Other Names:
  • Healthy Lifestyle intervention
  • Diet and Physical Activity intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI
Time Frame: Before intervention and after (12-14 weeks after first assessment)
Weight and Height assessed for both control and intervention participants before intervention program and then assessed 2-3 weeks after the intervention period completed.
Before intervention and after (12-14 weeks after first assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Waist Circumference
Time Frame: Measured before and after intervention (12 - 13 weeks after first assessment
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.
Measured before and after intervention (12 - 13 weeks after first assessment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting blood glucose
Time Frame: Measured before intervention and after (12-13 weeks after first assessment)
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.
Measured before intervention and after (12-13 weeks after first assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Marc B Schenker, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

May 8, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimate)

May 16, 2013

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 219631
  • S-MSPREIT (Other Identifier: UC Davis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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