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

Overweight and Obesity Clinical Trial

— Pasos  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855282
• Other study ID #: 219631
• Secondary ID: S-MSPREIT
• Status: Completed
• Phase: N/A
• First received: May 8, 2013
• Last updated: May 11, 2017
• Start date: April 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A more detailed description is not desired as noted above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

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.

Locations

Country	Name	City	State
United States	Reiter Affiliated Companies	Oxnard	California
United States	Reiter Affiliated Companies	Watsonville	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in fasting blood glucose	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)
Primary	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.	Before intervention and after (12-14 weeks after first assessment)
Secondary	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.	Measured before and after intervention (12 - 13 weeks after first assessment