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

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Behavioral: Behavioral Intervention

• Registration Number: NCT01855282
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2011-02
• Study Completion: 2011-04
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-16
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Behavioral Intervention	Control arm received no behavioral intervention
Behavioral intervention	Behavioral Intervention	Behavioral intervention consisting of 10 educational sessions promoting healthy diet and increased physical activity.

Primary Outcome Measures

Name	Time	Method
Change in BMI	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.

Secondary Outcome Measures

Name	Time	Method
Change in Waist Circumference	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.

Trial Locations

Locations (1)

Reiter Affiliated Companies; 🇺🇸 Watsonville, California, United States