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| ID | Type | Description | Link |
|---|---|---|---|
| 10/NIR02/28 | Other Identifier | ORECNI |
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| Name | Class |
|---|---|
| AXA PPP Healthcare | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| Web-based program | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based program | Behavioral | Provided with the web-based program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss Kg | Between-group change in weight loss at 3-month follow-up | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle McKinley, PhD | Queen's University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University Belfast | Belfast | Antrim | BT12 6BJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26183659 | Derived | Watson S, Woodside JV, Ware LJ, Hunter SJ, McGrath A, Cardwell CR, Appleton KM, Young IS, McKinley MC. Effect of a Web-Based Behavior Change Program on Weight Loss and Cardiovascular Risk Factors in Overweight and Obese Adults at High Risk of Developing Cardiovascular Disease: Randomized Controlled Trial. J Med Internet Res. 2015 Jul 16;17(7):e177. doi: 10.2196/jmir.3828. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | |
| FG001 | Web-based Program | Web-based program: Provided with the web-based program |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | |
| BG001 | Web-based Program | Web-based program: Provided with the web-based program |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Loss Kg | Between-group change in weight loss at 3-month follow-up | Weight (kg) outcome differences within study groups from baseline to 3 months (complete-case analysis). | Posted | Mean | 95% Confidence Interval | kg | 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle McKinley, Professor | Queen's University, Belfast | 02890978936 | m.mckinley@qub.ac.uk |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 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 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Weight Loss | Between-group change in weight loss at 6 and 12 months | Not Posted | 6 months and 12 months | Participants |
| Secondary | Physical Activity | Assessed by triaxial accelerometer and RPAQ questionnaire | Not Posted | 3 months, 6 months, 12 months | Participants |
| Secondary | Blood Pressure (Seated, Systolic and Diastolic mmHg) | Seated, systolic and diastolic mmHg | Not Posted | 3 months, 6 months, 12 months | Participants |
| Secondary | Biochemical Markers of CVD Risk | Total cholesterol HDL cholesterol, LDL cholesterol, triglycerides high-sensitivity CRP, HOMA, HbA1c | Not Posted | 3 months, 6 months, 12 months | Participants |
| Secondary | Dietary Intake | Diet history | Not Posted | 3 months, 6 months, 12 months | Participants |
| Secondary | Pulse Wave Analysis | SpygmoCor Pulse Wave Analysis System | Not Posted | 3 months, 6 months, 12 months | Participants |
| Secondary | Quality of Life | Questionnaire | Not Posted | 3 months, 6 months, 12 months | Participants |
| Secondary | Sleep Quality | Questionnaire | Not Posted | 3 months, 6 months, 12 months | Participants |
| Secondary | Self-esteem | Questionnaire | Not Posted | 3 months, 6 months, 12 months | Participants |
| Secondary | Self-efficacy | Questionnaire | Not Posted | 3 months, 6 months, 12 months | Participants |
| Secondary | Depression | Questionnaire | Not Posted | 3 months, 6 months, 12 months | Participants |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Web-based Program | Web-based program: Provided with the web-based program | 0 | 32 | 0 | 32 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |