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

NCT01855282 | Completed

• 2 other identifiers: 219631S-MSPREIT
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight and Obesity

Keywords

Diabetes Type II,; Overweight,; Obesity,; Behavioral Intervention,; Latino, farm worker; randomized controlled intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Waist Circumference

  Measured before and after intervention (12 - 13 weeks after first assessment

Other Outcomes (1)

• Change in fasting blood glucose

  Measured before intervention and after (12-13 weeks after first assessment)

Study Arms (2)

Behavioral intervention

EXPERIMENTAL

Behavioral intervention consisting of 10 educational sessions promoting healthy diet and increased physical activity.

Behavioral: Behavioral Intervention

Control

ACTIVE COMPARATOR

Control arm received no behavioral intervention

Behavioral: Behavioral Intervention

Interventions

Behavioral Intervention BEHAVIORAL

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.

Also known as: Healthy Lifestyle intervention, Diet and Physical Activity intervention

Behavioral intervention; Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 -60
• BMI between 20 -38
• Willing to attend 10 weekly education sessions
• Able to speak and understand Spanish
• Have medical insurance

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (2)

Reiter Affiliated Companies

Oxnard, California, 93030, United States

Location

Reiter Affiliated Companies

Watsonville, California, 95076, United States

Location

Related Publications (1)

• Mitchell DC, Andrews T, Schenker MB. Pasos Saludables: A Pilot Randomized Intervention Study to Reduce Obesity in an Immigrant Farmworker Population. J Occup Environ Med. 2015 Oct;57(10):1039-46. doi: 10.1097/JOM.0000000000000535.

  PMID: 26461858 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2

Interventions

Behavior Therapy; Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Marc B Schenker, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 16, 2013
• Study Start: April 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

US (2)