Resumen

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

Elegibilidad

Edad mínima: 25 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Male or female 25-70 years of age
Obese (BMI ≥ 30 kg/m2 and \<40 kg/m2)
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
Participant must be willing and able to provide written informed consent
Participant must be willing and able to comply with study related procedures
Participant must have access to Internet and e-mail

Criterios de exclusión

Stage 1 or 2 on Patient Activation Measures tool
Weight change of more than 5 kg during the 3 months preceding the screening visit
History of bariatric surgery
Fasting Plasma Glucose at screening \> 250 mg/dL (\> 13.9 mmol/L)
Hemoglobin A1c at screening \>8.5%
Treatment of type 2 diabetes with insulin (except for history of intermittent acute use, no more than 2 weeks usage in previous 6 months)
Uncontrolled or inadequately controlled hypertension at the time of screening with blood pressure \>160/100 mmHg
Secondary hypertension
Changes in lipid, blood pressure or diabetes modifying agents including introduction, change in dose or cessation in the 3 months prior to Screening Visit
Personal history of coronary heart disease, congestive heart failure, serious arrhythmias and stroke
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.
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
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
Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
Use of any investigational agent (drug, biologic, device) within 3 months prior to screening

Intervenciones

behavioral

Web-based lifestyle modification

Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance.

behavioral

Web-based lifestyle modification +

Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance plus telephone counseling support by health coaches on a weekly or bi-weekly basis.

A 6-Month, Randomized Study to Evaluate the Efficacy of a Web-based Lifestyle Modification Program With and Without Telephone Counseling Support