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| ID | Type | Description | Link |
|---|---|---|---|
| R18DK096429 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral intervention | Experimental | Behavioral intervention consisting of 12 educational sessions promoting healthy diet and increased physical activity |
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| Control | Active Comparator | Control arm receives no health-related behavioral intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI | Weight and height will be assessed at each data collection point and concurrently for control and intervention participants on matched ranches. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in waist circumference | Waist circumference will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Schenker, MD, MPH | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reiter Brothers Inc. | Oxnard | California | 93030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29986676 | Derived | Borelli MR, Riden HE, Bang H, Schenker MB. Protocol for a cluster randomized controlled trial to study the effectiveness of an obesity and diabetes intervention (PASOS) in an immigrant farmworker population. BMC Public Health. 2018 Jul 9;18(1):849. doi: 10.1186/s12889-018-5560-0. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D004032 | Diet |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
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| Control | Other | Control arm receives no health-related behavioral intervention |
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| Change in hemoglobin A1c (HbA1c) | HbA1c will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol. | 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 cholesterol | Cholesterol will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol. | 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 | 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. | Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention. |
| Cost analysis | Assessment of intervention's impact on employer costs. | Quarterly beginning a year prior to implementation of the intervention and concluding 1.5 years post-intervention. |
| Change in blood pressure | Change in blood pressure will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol. | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010829 | Physiological Phenomena |