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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
  Purpose

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.


Condition Intervention Phase
Obesity
 Behavioral: Web-based program
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Queen's University, Belfast:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Between-group change in weight loss at 3-month follow-up


Secondary Outcome Measures:
  • 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


Enrollment: 65
Study Start Date: April 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Active Comparator: Web-based program Behavioral: Web-based program
Provided with the web-based program

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472276

Locations
United Kingdom
Queen's University Belfast
Belfast, Antrim, United Kingdom, BT12 6BJ
Sponsors and Collaborators
Queen's University, Belfast
AXA PPP Healthcare
Investigators
Principal Investigator: Michelle McKinley, PhD Queen's University, Belfast
  More Information

No publications provided

Responsible Party: Michelle McKinley, Lecturer, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT01472276     History of Changes
Other Study ID Numbers: 10041MMcK-OPMS, 10/NIR02/28
Study First Received: November 9, 2011
Last Updated: March 11, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen's University, Belfast:
Behaviour change
Weight loss
Cardiovascular risk
Diet
 Physical activity
Overweight
Obesity
Internet

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on June 18, 2013