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

NCT01664026 | Withdrawn

• 1 other identifier: PWeb123
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in body weight from randomization to 6 months

  6 months

Secondary Outcomes (5)

• 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 Outcomes (2)

• Changes in lifestyle behaviors (physical activity and eating habits)

  6 months

• Changes in quality of life

  6 months

Study Arms (3)

Control

NO INTERVENTION

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

Web

EXPERIMENTAL

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

Web+

EXPERIMENTAL

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 +

Interventions

Web-based lifestyle modification + 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.

Web+

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clínica Bazterrica: lead

Study Sites (1)

Clinica Bazterrica

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andres Digenio, MD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jefe de Prevencion y Rehabilitacion

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 14, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 1, 2019

Record last verified: 2019-01

Locations

AR (1)