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

June 27, 2022 updated by: Michelle McKinley, Queen's University, Belfast

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Antrim
      • Belfast, Antrim, United Kingdom, BT12 6BJ
        • Queen's University Belfast

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Web-based program
Behavioral: Web-based program
Provided with the web-based program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss Kg
Time Frame: 3 months
Between-group change in weight loss at 3-month follow-up
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-esteem
Time Frame: 3 months, 6 months, 12 months
Questionnaire
3 months, 6 months, 12 months
Self-efficacy
Time Frame: 3 months, 6 months, 12 months
Questionnaire
3 months, 6 months, 12 months
Depression
Time Frame: 3 months, 6 months, 12 months
Questionnaire
3 months, 6 months, 12 months
Weight Loss
Time Frame: 6 months and 12 months
Between-group change in weight loss at 6 and 12 months
6 months and 12 months
Physical Activity
Time Frame: 3 months, 6 months, 12 months
Assessed by triaxial accelerometer and RPAQ questionnaire
3 months, 6 months, 12 months
Blood Pressure (Seated, Systolic and Diastolic mmHg)
Time Frame: 3 months, 6 months, 12 months
Seated, systolic and diastolic mmHg
3 months, 6 months, 12 months
Biochemical Markers of CVD Risk
Time Frame: 3 months, 6 months, 12 months
Total cholesterol HDL cholesterol, LDL cholesterol, triglycerides high-sensitivity CRP, HOMA, HbA1c
3 months, 6 months, 12 months
Dietary Intake
Time Frame: 3 months, 6 months, 12 months
Diet history
3 months, 6 months, 12 months
Pulse Wave Analysis
Time Frame: 3 months, 6 months, 12 months
SpygmoCor Pulse Wave Analysis System
3 months, 6 months, 12 months
Quality of Life
Time Frame: 3 months, 6 months, 12 months
Questionnaire
3 months, 6 months, 12 months
Sleep Quality
Time Frame: 3 months, 6 months, 12 months
Questionnaire
3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University, Belfast

Collaborators

AXA PPP Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 11, 2011

First Posted (Estimate)

November 16, 2011

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

June 27, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10041MMcK-OPMS
  • 10/NIR02/28 (Other Identifier: ORECNI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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