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

May 8, 2013
August 22, 2013
April 2010
February 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01855282 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Same as current
 
Assessment of an Intervention to Prevent Obesity and Diabetes in Latino Farm Workers
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.

A more detailed description is not desired as noted above.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Overweight and Obesity
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
  • Experimental: Behavioral intervention
    Behavioral intervention consisting of 10 educational sessions promoting healthy diet and increased physical activity.
    Intervention: Behavioral: Behavioral Intervention
  • Active Comparator: Control
    Control arm received no behavioral intervention
    Intervention: Behavioral: Behavioral Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
254
April 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01855282
S-MSPREIT
No
Marc Schenker, MD MPH, University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: Marc B Schenker, MD University of California, Davis
University of California, Davis
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP