Efficacy of a Web-based Lifestyle Modification Program in Obese Patients With Cardiovascular Risk Factors
Efficacy of a Web-based Lifestyle Modification Program in Obese Patients With Cardiovascular Risk Factors
To evaluate the effect of a 6-month web-based lifestyle modification program with and without
 telephone counseling versus usual care in obese patients with cardiovascular risk factors on:

 -  Weight Loss

 -  Waist circumference; blood pressure; total cholesterol, triglycerides, LDL-cholesterol,
 HDL-cholesterol; glucose and hemoglobin A1c; C-reactive protein.

 -  Physical activity and eating habits

 -  Quality of life
Inclusion Criteria:

 1. Male or female 25-70 years of age

 2. Obese (BMI ≥ 30 kg/m2 and <40 kg/m2)

 3. At least 2 cardiovascular risk factors (diabetes, hypertension or dyslipidemia) i)
 Hypertension defined by a history of hypertension, treatment of hypertension or BP
 values >140/90 mmHg in two consecutive office visits ii) High cholesterol defined by
 an LDL-C ≥130 mg/dL and/or HDL-C <40 mg/dL and triglycerides ≥150 mg/dL iii) Type 2
 Diabetes Mellitus defined by a history of diabetes, treatment of diabetes or fasting
 glucose ≥126 mg/dL in two consecutive office visits

 4. Participant must be willing and able to provide written informed consent

 5. Participant must be willing and able to comply with study related procedures

 6. Participant must have access to Internet and e-mail

 Exclusion Criteria:

 1. Stage 1 or 2 on Patient Activation Measures tool

 2. Weight change of more than 5 kg during the 3 months preceding the screening visit

 3. History of bariatric surgery

 4. Fasting Plasma Glucose at screening > 250 mg/dL (> 13.9 mmol/L)

 5. Hemoglobin A1c at screening >8.5%

 6. Treatment of type 2 diabetes with insulin (except for history of intermittent acute
 use, no more than 2 weeks usage in previous 6 months)

 7. Uncontrolled or inadequately controlled hypertension at the time of screening with
 blood pressure >160/100 mmHg

 8. Secondary hypertension

 9. Changes in lipid, blood pressure or diabetes modifying agents including introduction,
 change in dose or cessation in the 3 months prior to Screening Visit

 10. Personal history of coronary heart disease, congestive heart failure, serious
 arrhythmias and stroke

 11. Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or
 other major systemic disease making implementation of the protocol or interpretation
 of the study results difficult.

 12. Presence of any condition (medical, psychological, social, or geographical), actual or
 anticipated, that in the opinion of the Investigator would restrict or limit the
 patient's successful participation for the duration of the study

 13. Presence of history of cancer within the past five years with the exception of
 adequately treated localized basal cell skin cancer or in situ uterine cervical cancer

 14. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for
 one week or more within 3 months prior to the time of screening

 15. Use of any investigational agent (drug, biologic, device) within 3 months prior to
 screening