Background
Aims
Methods/Design
Study Design
Eligibility 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. |
Recruitment and Screening Process
Randomization and Blinding
Baseline and Follow-up Measures and Data Collection
Follow-up Month | ||||
---|---|---|---|---|
Baseline | 3 | 6 | 15 | |
Clinical Measures
| ||||
Height | X | |||
Weight | X | X | X | X |
Waist circumference | X | X | X | X |
Blood pressure | X | X | X | X |
Fasting blood: Total cholesterol, LDL-C, HDL-C, triglycerides, glucose, hemoglobin A1c | X | X | X | |
C-reactive protein (CRP) | X | X | ||
Questionnaires
| ||||
Demographics | X | |||
Family medical history | X | |||
Three-day food record | X | X | X | X |
Eating Habits Confidence Survey | X | X | X | X |
Social Support and Eating Habits Survey | X | X | X | X |
Stanford Seven-day Physical Activity Recall | X | X | X | X |
Exercise Confidence Survey | X | X | X | X |
Social Support and Exercise Survey | X | X | X | X |
Smoking and alcohol consumption | X | X | ||
12-item Short Form Health Survey (SF-12) | X | X | X | X |
Obesity Related Problems Scale | X | X | X | X |
Nine-item Patient Health Questionnaire (PHQ-9) | X | X | X | X |
Depression Anxiety Stress Scale | X | X | X | X |
Symptoms | X | X | X | X |
Adverse events | X | X | X | |
Medication use | X | X | X | X |
Care at non-PAMF health care facilities | X | X | X | X |
Unified Theory of Acceptance and Use of Technology1
| X | X | X | |
Data extracted from PAMF electronic databases
| ||||
Current medical problems | X | X | ||
Medications prescribed | X | X | ||
Health care utilization | X | X | ||
PCP characteristics | X |