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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marc Schenker, MD MPH, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01855282
First received: May 8, 2013
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Overweight and Obesity
Behavioral: Behavioral Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pasos Saludables: A Pilot Intervention to Prevent Obesity and Diabetes Among Latino Farm Workers

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Change in BMI [ Time Frame: Before intervention and after (12-14 weeks after first assessment) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Measured before and after intervention (12 - 13 weeks after first assessment ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Change in fasting blood glucose [ Time Frame: Measured before intervention and after (12-13 weeks after first assessment) ] [ Designated as safety issue: No ]
    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.


Enrollment: 254
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

A more detailed description is not desired as noted above.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855282

Locations
United States, California
Reiter Affiliated Companies
Oxnard, California, United States, 93030
Reiter Affiliated Companies
Watsonville, California, United States, 95076
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Marc B Schenker, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Marc Schenker, MD MPH, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT01855282     History of Changes
Other Study ID Numbers: S-MSPREIT
Study First Received: May 8, 2013
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Diabetes Type II,
Overweight,
Obesity,
Behavioral Intervention,
Latino, farm worker
randomized controlled intervention

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014