Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos (E-LITE Latinos)

This is an interventional health services research trial for Prediabetic State focused on measuring prediabetes, metabolic syndrome, lifestyle, behavior change, primary care, latinos, diet, physical activity Read More

Inclusion criteria:

• Age(as of date of enrollment):

  • Lower age limit: 18 years
  • Upper age limit: NONE (only exclude for cause, e.g. disease and functional limitations, as detailed below)
• Race/ethnicity: Mexican Latino of any race
• Gender: men and women
• Body mass index: ≥24 kg/m2 (≥22 kg/m2 if of Asian descent)
• Having pre-diabetes, metabolic syndrome, or both based on the following criteria:
• Pre-diabetes according to any one of the following criteria:
• Fasting plasma glucose of 100 to 125 mg/dL or HbA1c of 5.7 to 6.4 if detected by a recent (within the past year), documented, blood-based diagnostic test or by a fasting blood test during study screening
• Plasma glucose measured 2 hours after a 75 gm glucose load of 140 to 199 mg/dl if detected by a recent (within the past year), documented, blood-based diagnostic test (Oral glucose tolerance test will not be performed for study screening considering participant burden)
• Clinically diagnosed gestational diabetes mellitus during a previous pregnancy (may be self-reported)

• Metabolic syndrome according to 3 or more of the following:

  • Waist circumference ≥40 inches in men and ≥35 inches in women (≥35 inches in men and ≥31 inches in women, if of Asian descent)
  • Triglycerides >150 mg/dL
  • High-density lipoprotein cholesterol (HDL-C) <40 mg/dL in men and <50 mg/dL in women
  • Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg
  • Fasting plasma glucose of 100 to 125 mg/dL
• Primary Care Physician approval of patient contact for study screening
• Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of two study arms, participate in follow-up for 24 months, and authorize extraction of relevant information from the Electronic Health Record.

Exclusion criteria:

• Medical exclusions:
• Previous diagnosis of diabetes (other than during pregnancy) or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening;
• Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years;
• Serious medical condition anticipated to prevent person from walking 1 mile (e.g., severe pulmonary disease or aortic stenosis)
• Severe medical co-morbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure;
• Diagnosis of a terminal illness and/or in hospice care;
• Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication
• Initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (The patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.)
• Have had or plan to undergo bariatric surgery during the study period
• Other exclusions:
• Inability to speak, read or understand Spanish or English
• Having no reliable telephone service
• Having no regular Internet access via a computer and/or mobile device (e.g., smart-phone)
• Currently pregnant or lactating or planning to become pregnant during the study period
• Plan to move out of the area during the study period
• Family/household member of another study participant or of a study staff member
• Investigator discretion for clinical safety or protocol adherence reasons