Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care (E-LITE)

This is an interventional health services research trial for Obesity focused on measuring Diabetes, Cardiovascular disease, Metabolic syndrome, Cardiometabolic Read More

Inclusion Criteria:

• Ethnicity: All ethnic groups;
• Body mass index 25.0-39.9 kg/m2;
• Fasting plasma glucose between 100 and 125 mg/dL;
• Any two of the following: Waist circumference >40 inches in men, >35 inches in women (if in Asian American ≥ 35 inches in men; ≥31 inches in women); Triglycerides >150 mg/dL; High-density lipoprotein cholesterol (HDL-C) <40 mg/dL in men, <50 mg/dL in women; Systolic blood pressure >130 mm Hg or diastolic blood pressure >85 mm Hg.
• Having a primary care physician (PCP) at the PAMF Los Altos Center;
• Seen in primary or specialty care in the Palo Alto Region at least once in the preceding 24 months;
• A PAMF patient for ≥ 12 months;
• Able and willing to enroll and meet the requirements of the study.

Exclusion Criteria:

• Inability to speak, read or understand English;
• No regular access to a computer with Internet and email capabilities;
• Triglycerides >400 mg/dL;
• Systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg;
• Initiation or change of drug therapy for elevated blood pressure or abnormal lipid levels within the past 3 months
• Having a medical (e.g., celiac disease) or social condition (e.g., religious beliefs) that precludes dietary changes;
• Having a medical or physical condition that make moderate intensity physical activity (like a brisk walk) difficult or unsafe;
• Use of weight-loss medications in the past 3 months;
• Regular use (> 5 days/month) of medications that affect appetite or weight (e.g., oral corticosteroids, insulin, certain oral hypoglycemics, certain antidepressants, etc.);
• Currently enrolled in a lifestyle intervention program at PAMF or elsewhere;
• Planning to undergo a bariatric surgery during the study period;
• Diagnosis of Type 1 or Type 2 diabetes mellitus;
• Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal, liver), heart disease, stroke, and ongoing substance abuse;
• Renal insufficiency (i.e., GFR < 60 mL/min/1.73m2)
• Diagnosis of psychiatric disorders that would limit adequate informed consent or ability to comply with study protocol;
• Diagnosis of cancer (other than non-melanoma skin cancer) that was active or treated with radiation or chemotherapy within the past 2 years;
• Diagnosis of a terminal illness and/or in hospice care;
• Pregnant, lactating or planning to become pregnant during the study period;
• Already enrolled or planning to enroll in a research study that would limit full participation in this study or confound the observation and interpretation of the study's findings;
• Family/household member of another study participant or of a study staff member;
• No longer a PAMF patient or planning to transfer care outside of PAMF during the study period;
• Planning to move out of the area during the study period;
• PCP determination that the study is inappropriate or unsafe for the patient;
• Investigator discretion for clinical safety or protocol adherence reasons.