Phase 2
N=65
Effect of a Unique Web-based Behaviour Change Program on Weight Loss and Cardiovascular Risk Factors
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01472276 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Weight Loss Kg — -0.53; -4.37 kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Web-based program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Queen's University, Belfast
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Loss Kg |
-0.53; -4.37 | — |
| SECONDARY Weight Loss |
— | — |
| SECONDARY Physical Activity |
— | — |
| SECONDARY Blood Pressure (Seated, Systolic and Diastolic mmHg) |
— | — |
| SECONDARY Biochemical Markers of CVD Risk |
— | — |
| SECONDARY Dietary Intake |
— | — |
| SECONDARY Pulse Wave Analysis |
— | — |
| SECONDARY Quality of Life |
— | — |
| SECONDARY Sleep Quality |
— | — |
| SECONDARY Self-esteem |
— | — |
| SECONDARY Self-efficacy |
— | — |
| SECONDARY Depression |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01472276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.