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

This study has been completed.

Sponsor:

Collaborator:

AXA PPP Healthcare

Information provided by (Responsible Party):

Michelle McKinley, Queen's University, Belfast

ClinicalTrials.gov Identifier:

NCT01472276

First received: November 9, 2011

Last updated: March 11, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 9, 2011

Last Updated Date

March 11, 2013

Start Date ^ICMJE

April 2011

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01472276 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Weight loss [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Physical activity [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Assessed by triaxial accelerometer and RPAQ questionnaire
Blood pressure (Seated, systolic and diastolic mmHg) [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Seated, systolic and diastolic mmHg
Biochemical markers of CVD risk [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Total cholesterol HDL cholesterol, LDL cholesterol, trihlycerides high-sensitivity CRP, HOMA, HbA1c
Dietary intake [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Diet history
Pulse wave analysis [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
SpygmoCor Pulse Wave Analysis System
Quality of life [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Questionnaire
Sleep quality [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Questionnaire
Self-esteem [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Questionnaire
Self-efficacy [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Questionnaire
Depression [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Questionnaire

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Behavioral: Web-based program

Provided with the web-based program

Study Arm (s)

No Intervention: Control
Active Comparator: Web-based program
Intervention: Behavioral: Web-based program

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2013

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01472276

Other Study ID Numbers ^ICMJE

10041MMcK-OPMS, 10/NIR02/28

Has Data Monitoring Committee

Responsible Party

Michelle McKinley, Queen's University, Belfast

Study Sponsor ^ICMJE

Queen's University, Belfast

Collaborators ^ICMJE

AXA PPP Healthcare

Investigators ^ICMJE

Principal Investigator:

Michelle McKinley, PhD

Queen's University, Belfast

Information Provided By

Queen's University, Belfast

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top