Clinical trial NCT01472276: Effect of a Unique Web-based Behaviour Change Program on Weight Loss and Cardiovascular Risk Factors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Behaviour change
Weight loss
Cardiovascular risk
Diet
Physical activity
Overweight
Obesity
Internet
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: AXA PPP Healthcare
First posted: 2011-11-16
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Weight Loss Kg
timeFrame: 3 months
Secondary outcomes:
measure: Weight Loss
timeFrame: 6 months and 12 months
measure: Physical Activity
timeFrame: 3 months, 6 months, 12 months
measure: Blood Pressure (Seated, Systolic and Diastolic mmHg)
timeFrame: 3 months, 6 months, 12 months
measure: Biochemical Markers of CVD Risk
timeFrame: 3 months, 6 months, 12 months
measure: Dietary Intake
timeFrame: 3 months, 6 months, 12 months
measure: Pulse Wave Analysis
timeFrame: 3 months, 6 months, 12 months
measure: Quality of Life
timeFrame: 3 months, 6 months, 12 months
measure: Sleep Quality
timeFrame: 3 months, 6 months, 12 months
measure: Self-esteem
timeFrame: 3 months, 6 months, 12 months
measure: Self-efficacy
timeFrame: 3 months, 6 months, 12 months
measure: Depression
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
state: Antrim
Study officials:
affiliation: Queen's University, Belfast
name: Michelle McKinley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.