Efficacy of a Web-based Lifestyle Modification Program in Obese Patients With Cardiovascular Risk Factors

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

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

Study Overview

• Status: Withdrawn
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Web-based lifestyle modification; Behavioral: Web-based lifestyle modification +

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Clinica Bazterrica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Subjects assigned to the usual care group will receive general lifestyle recommendations as per their country standards of care.
Experimental: Web; 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.
Experimental: Web+; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in body weight from randomization to 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in waist circumference	6 months
Changes in blood pressure	6 months
Changes in lipid parameters (total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol)	6 months
Changes in glycemic parameters (glucose and hemoglobin A1c)	6 months
Changes in C-reactive protein	6 months

Other Outcome Measures

Outcome Measure	Time Frame
Changes in lifestyle behaviors (physical activity and eating habits)	6 months
Changes in quality of life	6 months

Collaborators and Investigators

• Sponsor: Clínica Bazterrica
• Investigators: Study Director: Andres Digenio, MD

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: August 9, 2012
• First Submitted That Met QC Criteria: August 10, 2012
• First Posted (Estimate): August 14, 2012

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PWeb123