Table 1

Participant inclusion and exclusion criteria

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.

Ma et al. BMC Family Practice 2009 10:71   doi:10.1186/1471-2296-10-71

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