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Completed

NCT Number: NCT02480244

PASOS: Improving the Health of Immigrant Workers

This is a cluster randomized trial (CRT) 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. Randomization is at the farm ranch level. Individuals at intervention ranches will receive a multi-week curriculum at the work-site on diabetes, diet and physical activity and optional supplemental sessions in the evening and weekends. The investigators will adopt the intent-to-treat principle for the primary analysis. Individuals on control ranches will receive no health educational instruction. The primary outcome is BMI. The investigators hypothesize that intervention ranches will achieve significant improvement in obesity and diabetes risk factors as compared to control ranches.

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Key information

Conditions

Overweight and Obesity Body Weight Diabetes Diabetes Mellitus 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reiter Brothers Inc.

Oxnard, California, 93030, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Work at Reiter Brothers Inc. (RBI), a partner, or affiliate company
  • Able to speak and understand Spanish
  • Willing to attend weekly sessions for length of intervention
  • Plan to stay in the area for the next three months

Exclusion criteria

  • Workers without Spanish language comprehension
  • Pregnant women and those planning a pregnancy within six months
  • Women who are breastfeeding, unless discontinuing breastfeeding within one month
  • Individuals who, without health care provider approval, are: unable to undertake moderate physical exercise, taking medicine for high blood pressure or heart conditions, have bone or joint problems, lose consciousness or fall due to dizziness, or have developed chest pain within the last month
  • Individuals taking medications that affect weight
  • Individuals with therapeutic diets
  • Diabetic status determined by health care professional after HbA1c testing result is >6.5%
  • If spouse / cohabitant is already in the study

Treatment and study plan

behavioral intervention

Behavioral

Intervention participants attend up to 12 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions are conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support are 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

Control

Other

Control arm receives no health-related behavioral intervention

Primary outcomes

  1. Change in BMI

    Time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.

    Weight and height will be assessed at each data collection point and concurrently for control and intervention participants on matched ranches.

Secondary outcomes

  1. Change in waist circumference

    Time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.

    Waist circumference will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.

  2. Change in hemoglobin A1c (HbA1c)

    Time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.

    HbA1c will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.

  3. Change in cholesterol

    Time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.

    Cholesterol will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.

  4. Change in behavior and lifestyle factors

    Time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.

    Change in behavior and lifestyle factors will be assessed concurrently for control and intervention participants on matched ranches using a questionnaire comprised of validated measures.

  5. Cost analysis

    Time frame: Quarterly beginning a year prior to implementation of the intervention and concluding 1.5 years post-intervention.

    Assessment of intervention's impact on employer costs.

  6. Change in blood pressure

    Time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.

    Change in blood pressure will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Translating Obesity and Diabetes Prevention Into the Worksite for Immigrant Populations

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 24, 2015
Registry last updated
Aug 7, 2020

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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