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Table 1 Participant inclusion and exclusion criteria

From: Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial

Inclusion criteria
   1. Ethnicity: All ethnic groups;
   2. Gender: Men and Women;
   3. Age (as of date of enrollment):
a). Lower age limit: 18 years;
b). Upper age limit: NONE (only exclude for cause, e.g. diseases, functional limitations detailed below);
   4. Body mass index ≥ 25.0 kg/m2;
   5.Having pre-diabetes and/or metabolic syndrome based on the following criteria:
a). Pre-diabetes: fasting plasma glucose between 100 and 125 mg/dL;
b). Metabolic syndrome: Three or more 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;
--Fasting plasma glucose between 100 and 125 mg/dL.
   6. Having a primary care physician (PCP);
   7. Able and willing to enroll and provide written, informed consent, i.e., to: 1) meet the time and data collection requirements of the study; 2) be randomized to one of the three intervention arms; 3) adhere to the recommendations of the study intervention as assigned; 4) participate in follow-up for 12 months; and 5) allow extraction of relevant information from their medical records.
Exclusion criteria
   1. Inability to speak, read or understand English;
   2. No regular access to a computer with Internet and email capabilities;
   3. Triglycerides ≥ 400 mg/dL;
   4. Systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg;
   5. Initiation or change of drug therapy for elevated blood pressure or abnormal lipid levels within the past 3 months;
   6. Initiation or change of antidepressant medication within the past 3 months;
   7. Having a medical or physical condition that make moderate intensity physical activity (like a brisk walk) difficult or unsafe;
   8. Use of weight-loss medications in the past 3 months;
   9. Regular use (> 5 days/month) of medications that affect appetite or weight (e.g., oral corticosteroids, insulin, oral hypoglycemics etc.);
   10. Currently enrolled in a lifestyle intervention program at PAMF or elsewhere;
   11. Planning to undergo bariatric surgery during the study period;
   12. Diagnosis of Type 1 or Type 2 diabetes mellitus;
   13. Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal, liver), heart disease, stroke, and ongoing substance abuse;
   14. Renal insufficiency (i.e. glomerular filtration rate < 60 mL/min/1.73 m2)
   15. Diagnosis of psychiatric disorders that would limit adequate informed consent or ability to comply with study protocol;
   16. Diagnosis of cancer (other than non-melanoma skin cancer) that was active or treated with radiation or chemotherapy within the past 2 years;
   17. Diagnosis of a terminal illness and/or in hospice care;
   18. Pregnant, lactating or planning to become pregnant during the study period;
   19. 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;
   20. Family/household member of another study participant or of a study staff member;
   21. No longer a PAMF patient or planning to transfer care outside of PAMF during the study period;
   22. Planning to move out of the area during the study period;
   23. PCP determination that the study is medically inappropriate or unsafe for the patient;
   24. Investigator discretion for clinical safety or protocol adherence reasons.