Effect of a Unique Web-based Behaviour Change Program on Weight Loss and Cardiovascular Risk Factors

Phase 2

Completed

• Conditions: Obesity
• Interventions: Behavioral: Web-based program

• Registration Number: NCT01472276
• Lead Sponsor: Queen's University, Belfast

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-11
• Study First Posted: 2011-11-16
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2022-06
• Results First Submitted: 2022-06-27
• Results First Submitted QC: 2022-06-27
• Last Update Submitted: 2022-06-27
• Results First Posted: 2023-05-01
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-based program	Web-based program	-

Primary Outcome Measures

Name	Time	Method
Weight Loss Kg	3 months	Between-group change in weight loss at 3-month follow-up

Secondary Outcome Measures

Name	Time	Method
Weight Loss	6 months and 12 months	Between-group change in weight loss at 6 and 12 months
Physical Activity	3 months, 6 months, 12 months	Assessed by triaxial accelerometer and RPAQ questionnaire
Dietary Intake	3 months, 6 months, 12 months	Diet history
Depression	3 months, 6 months, 12 months	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
Pulse Wave Analysis	3 months, 6 months, 12 months	SpygmoCor Pulse Wave Analysis System
Quality of Life	3 months, 6 months, 12 months	Questionnaire
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

Trial Locations

Locations (1)

Queen's University Belfast; 🇬🇧 Belfast, Antrim, United Kingdom