Effect of a Unique Web-based Behaviour Change Program on Weight Loss and Cardiovascular Risk Factors

Study Overview
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Brief Summary
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Web- or internet-based programs have the potential to induce and, possibly, help to sustain, significant lifestyle modification. This study will evaluate the effect of a unique interactive web-based behaviour change program on weight loss and cardiovascular risk factors in people who are overweight or obese and at high risk of cardiovascular disease.

Official Title
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Effect of a Unique Web-based Behaviour Change Program for Physical Activity and Weight Management on Weight Loss and Cardiovascular Risk Factors in Overweight or Obese Adults at High Risk of Cardiovascular Disease

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Web-based program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years old Have regular access to the internet, telephone and have an e-mail address. Body mass index (BMI) greater than 27 and less than 40 Sedentary Have one or more of the following risk factors associated with cardiovascular disease: Elevated blood pressure ≥ 140 mm Hg systolic or ≥ 90 mm Hg diastolic; Elevated total cholesterol ≥ 5.0; Type 2 diabetes Be willing to refrain from participating in another behaviour change program for the duration of the study Exclusion Criteria: Major health problems including Type 1 diabetes, established CVD, renal and hepatic disease Psychiatric problems Pregnancy Excessive alcohol consumption

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Active Comparator: Web-based program<br> | Behavioral: Web-based program<br>* Provided with the web-based program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss Kg | Between-group change in weight loss at 3-month follow-up | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Between-group change in weight loss at 6 and 12 months | 6 months and 12 months | 
| Physical Activity | Assessed by triaxial accelerometer and RPAQ questionnaire | 3 months, 6 months, 12 months | 
| Blood Pressure (Seated, Systolic and Diastolic mmHg) | Seated, systolic and diastolic mmHg | 3 months, 6 months, 12 months | 
| Biochemical Markers of CVD Risk | Total cholesterol HDL cholesterol, LDL cholesterol, triglycerides high-sensitivity CRP, HOMA, HbA1c | 3 months, 6 months, 12 months | 
| Dietary Intake | Diet history | 3 months, 6 months, 12 months | 
| Pulse Wave Analysis | SpygmoCor Pulse Wave Analysis System | 3 months, 6 months, 12 months | 
| Quality of Life | Questionnaire | 3 months, 6 months, 12 months | 
| Sleep Quality | Questionnaire | 3 months, 6 months, 12 months | 
| Self-esteem | Questionnaire | 3 months, 6 months, 12 months | 
| Self-efficacy | Questionnaire | 3 months, 6 months, 12 months | 
| Depression | Questionnaire | 3 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behaviour change, Weight loss, Cardiovascular risk, Diet, Physical activity, Overweight, Obesity, Internet