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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Web-based program
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Behaviour change, Weight loss, Cardiovascular risk, Diet, Physical activity, Overweight, Obesity, Internet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Queen's University Belfast

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Web-based program

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Weight Loss
Between-group change in weight loss at 6 and 12 months
Physical Activity
Assessed by triaxial accelerometer and RPAQ questionnaire
Blood Pressure (Seated, Systolic and Diastolic mmHg)
Seated, systolic and diastolic mmHg
Biochemical Markers of CVD Risk
Total cholesterol HDL cholesterol, LDL cholesterol, triglycerides high-sensitivity CRP, HOMA, HbA1c
Dietary Intake
Diet history
Pulse Wave Analysis
SpygmoCor Pulse Wave Analysis System
Quality of Life
Questionnaire
Sleep Quality
Questionnaire
Self-esteem
Questionnaire
Self-efficacy
Questionnaire
Depression
Questionnaire

Full Information

First Posted
November 9, 2011
Last Updated
June 27, 2022
Sponsor
Queen's University, Belfast
Collaborators
AXA PPP Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01472276
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
AXA PPP Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Behaviour change, Weight loss, Cardiovascular risk, Diet, Physical activity, Overweight, Obesity, Internet

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Web-based program
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Web-based program
Intervention Description
Provided with the web-based program
Primary Outcome Measure Information:
Title
Weight Loss Kg
Description
Between-group change in weight loss at 3-month follow-up
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Weight Loss
Description
Between-group change in weight loss at 6 and 12 months
Time Frame
6 months and 12 months
Title
Physical Activity
Description
Assessed by triaxial accelerometer and RPAQ questionnaire
Time Frame
3 months, 6 months, 12 months
Title
Blood Pressure (Seated, Systolic and Diastolic mmHg)
Description
Seated, systolic and diastolic mmHg
Time Frame
3 months, 6 months, 12 months
Title
Biochemical Markers of CVD Risk
Description
Total cholesterol HDL cholesterol, LDL cholesterol, triglycerides high-sensitivity CRP, HOMA, HbA1c
Time Frame
3 months, 6 months, 12 months
Title
Dietary Intake
Description
Diet history
Time Frame
3 months, 6 months, 12 months
Title
Pulse Wave Analysis
Description
SpygmoCor Pulse Wave Analysis System
Time Frame
3 months, 6 months, 12 months
Title
Quality of Life
Description
Questionnaire
Time Frame
3 months, 6 months, 12 months
Title
Sleep Quality
Description
Questionnaire
Time Frame
3 months, 6 months, 12 months
Title
Self-esteem
Description
Questionnaire
Time Frame
3 months, 6 months, 12 months
Title
Self-efficacy
Description
Questionnaire
Time Frame
3 months, 6 months, 12 months
Title
Depression
Description
Questionnaire
Time Frame
3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle McKinley, PhD
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University Belfast
City
Belfast
State/Province
Antrim
ZIP/Postal Code
BT12 6BJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26183659
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.
Results Reference
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Effect of a Unique Web-based Behaviour Change Program on Weight Loss and Cardiovascular Risk Factors

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