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Completed

NCT Number: NCT01855282

Assessment of an Intervention to Prevent Obesity and Diabetes in 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.

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Key information

Conditions

Overweight and Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reiter Affiliated Companies, Oxnard, California, United States

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About this study

A more detailed description is not desired as noted above.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Healthy Lifestyle intervention, Diet and Physical Activity intervention

Primary outcomes

  1. Change in BMI

    Time frame: 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 outcomes

  1. Change in Waist Circumference

    Time frame: 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.

Other outcomes

  1. Change in fasting blood glucose

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

    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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Acronym: Pasos

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 16, 2013
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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