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

Queen's University, Belfast1 site in 1 country65 target enrollmentApril 2011

ConditionsObesity

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Obesity
Sponsor: Queen's University, Belfast
Enrollment: 65
Locations: 1
Primary Endpoint: Weight Loss Kg
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

March 2013

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Queen's University, Belfast

Responsible Party

Principal Investigator

Michelle McKinley

Lecturer

Queen's University, Belfast

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

Outcomes

Primary Outcomes

Weight Loss Kg

Time Frame: 3 months

Between-group change in weight loss at 3-month follow-up

Secondary Outcomes

Weight Loss(6 months and 12 months)
Physical Activity(3 months, 6 months, 12 months)
Dietary Intake(3 months, 6 months, 12 months)
Depression(3 months, 6 months, 12 months)
Blood Pressure (Seated, Systolic and Diastolic mmHg)(3 months, 6 months, 12 months)
Biochemical Markers of CVD Risk(3 months, 6 months, 12 months)
Pulse Wave Analysis(3 months, 6 months, 12 months)
Quality of Life(3 months, 6 months, 12 months)
Sleep Quality(3 months, 6 months, 12 months)
Self-esteem(3 months, 6 months, 12 months)
Self-efficacy(3 months, 6 months, 12 months)