Diabetes, Overweight and Obesity
Conditions
Brief summary
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.
Interventions
BEHAVIORALBehavioral Intervention
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.
OTHERControl
Control arm receives no health-related behavioral intervention
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin A1c (HbA1c) | 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. |
| Change in cholesterol | 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. |
| Change in waist circumference | 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. |
| Cost analysis | 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. |
| Change in blood pressure | 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. |
| Change in behavior and lifestyle factors | 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. |
Countries
United States
Outcome results
None listed