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

NCT ID: NCT01664026

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-12-31

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

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Subjects assigned to the usual care group will receive general lifestyle recommendations as per their country standards of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Web-based lifestyle modification

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Web-based lifestyle modification +

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clínica Bazterrica

OTHER

Sponsor Role: lead

Responsible Party

Arnaldo Angelino

Jefe de Prevencion y Rehabilitacion

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andres Digenio, MD

Role: STUDY_DIRECTOR

Locations

Clinica Bazterrica

Buenos Aires, , Argentina

Countries

Argentina

Other Identifiers

PWeb123

Identifier Type: -

Identifier Source: org_study_id