Clinical trial NCT01664026: Efficacy of a Web-based Lifestyle Modification Program in Obese Patients With Cardiovascular Risk Factors
Official title: A 6-Month, Randomized Study to Evaluate the Efficacy of a Web-based Lifestyle Modification Program With and Without Telephone Counseling Support
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Lead sponsor: Clínica Bazterrica
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight from randomization to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Changes in waist circumference
timeFrame: 6 months
measure: Changes in blood pressure
timeFrame: 6 months
measure: Changes in lipid parameters (total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol)
timeFrame: 6 months
measure: Changes in glycemic parameters (glucose and hemoglobin A1c)
timeFrame: 6 months
measure: Changes in C-reactive protein
timeFrame: 6 months
Other outcomes:
measure: Changes in lifestyle behaviors (physical activity and eating habits)
timeFrame: 6 months
measure: Changes in quality of life
timeFrame: 6 months
Locations:
city: Buenos Aires
country: Argentina
facility: Clinica Bazterrica
Study officials:
name: Andres Digenio, MD
role: STUDY_DIRECTOR
References: