Obesity
Conditions
Keywords
Behaviour change, Weight loss, Cardiovascular risk, Diet, Physical activity, Overweight, Obesity, Internet
Brief summary
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.
Interventions
BEHAVIORALWeb-based program
Provided with the web-based program
Sponsors
AXA PPP Healthcare
Queen's University, Belfast
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss Kg | 3 months | Between-group change in weight loss at 3-month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 3 months, 6 months, 12 months | Assessed by triaxial accelerometer and RPAQ questionnaire |
| Blood Pressure (Seated, Systolic and Diastolic mmHg) | 3 months, 6 months, 12 months | Seated, systolic and diastolic mmHg |
| Biochemical Markers of CVD Risk | 3 months, 6 months, 12 months | Total cholesterol HDL cholesterol, LDL cholesterol, triglycerides high-sensitivity CRP, HOMA, HbA1c |
| Dietary Intake | 3 months, 6 months, 12 months | Diet history |
| Pulse Wave Analysis | 3 months, 6 months, 12 months | SpygmoCor Pulse Wave Analysis System |
| Weight Loss | 6 months and 12 months | Between-group change in weight loss at 6 and 12 months |
| Sleep Quality | 3 months, 6 months, 12 months | Questionnaire |
| Self-esteem | 3 months, 6 months, 12 months | Questionnaire |
| Self-efficacy | 3 months, 6 months, 12 months | Questionnaire |
| Depression | 3 months, 6 months, 12 months | Questionnaire |
| Quality of Life | 3 months, 6 months, 12 months | Questionnaire |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control | 33 |
| Web-based Program Web-based program: Provided with the web-based program | 32 |
| Total | 65 |
Baseline characteristics
| Characteristic | Control | Web-based Program | Total |
|---|---|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 7.27 | 51.4 years STANDARD_DEVIATION 7.59 | 52.1 years STANDARD_DEVIATION 7.4 |
| Sex: Female, Male Female | 20 Participants | 16 Participants | 36 Participants |
| Sex: Female, Male Male | 13 Participants | 16 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 32 |
| serious Total, serious adverse events | 0 / 33 | 0 / 32 |
Outcome results
Primary
Weight Loss Kg
Between-group change in weight loss at 3-month follow-up
Time frame: 3 months
Population: Weight (kg) outcome differences within study groups from baseline to 3 months (complete-case analysis).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Weight Loss Kg | -0.53 kg |
| Web-based Program | Weight Loss Kg | -4.37 kg |
Secondary
Biochemical Markers of CVD Risk
Total cholesterol HDL cholesterol, LDL cholesterol, triglycerides high-sensitivity CRP, HOMA, HbA1c
Time frame: 3 months, 6 months, 12 months
Secondary
Blood Pressure (Seated, Systolic and Diastolic mmHg)
Seated, systolic and diastolic mmHg
Time frame: 3 months, 6 months, 12 months
Secondary
Depression
Questionnaire
Time frame: 3 months, 6 months, 12 months
Secondary
Dietary Intake
Diet history
Time frame: 3 months, 6 months, 12 months
Secondary
Physical Activity
Assessed by triaxial accelerometer and RPAQ questionnaire
Time frame: 3 months, 6 months, 12 months
Secondary
Pulse Wave Analysis
SpygmoCor Pulse Wave Analysis System
Time frame: 3 months, 6 months, 12 months
Secondary
Quality of Life
Questionnaire
Time frame: 3 months, 6 months, 12 months
Secondary
Self-efficacy
Questionnaire
Time frame: 3 months, 6 months, 12 months
Secondary
Self-esteem
Questionnaire
Time frame: 3 months, 6 months, 12 months
Secondary
Sleep Quality
Questionnaire
Time frame: 3 months, 6 months, 12 months
Secondary
Weight Loss
Between-group change in weight loss at 6 and 12 months
Time frame: 6 months and 12 months