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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Arnaldo Angelino, Clínica Bazterrica
ClinicalTrials.gov Identifier:
NCT01664026
First received: August 9, 2012
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

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

Condition Intervention
Obesity
Behavioral: Web-based lifestyle modification
Behavioral: Web-based lifestyle modification +

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A 6-Month, Randomized Study to Evaluate the Efficacy of a Web-based Lifestyle Modification Program With and Without Telephone Counseling Support

Resource links provided by NLM:


Further study details as provided by Clínica Bazterrica:

Primary Outcome Measures:
  • Change in body weight from randomization to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in waist circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in lipid parameters (total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in glycemic parameters (glucose and hemoglobin A1c) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in C-reactive protein [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Changes in lifestyle behaviors (physical activity and eating habits) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664026

Locations
Argentina
Clinica Bazterrica
Buenos Aires, Argentina
Sponsors and Collaborators
Clínica Bazterrica
Investigators
Study Director: Andres Digenio, MD
  More Information

No publications provided

Responsible Party: Arnaldo Angelino, Jefe de Prevencion y Rehabilitacion, Clínica Bazterrica
ClinicalTrials.gov Identifier: NCT01664026     History of Changes
Other Study ID Numbers: PWeb123
Study First Received: August 9, 2012
Last Updated: August 10, 2012
Health Authority: Argentina: Human Research Bioethics Committee

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014