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

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ClinicalTrials.gov Identifier: NCT01472276
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : March 12, 2013
Sponsor:
Collaborator:
AXA PPP Healthcare
Information provided by (Responsible Party):
Michelle McKinley, 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Web-based program Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Weight loss [ Time Frame: 3 months ]
    Between-group change in weight loss at 3-month follow-up


Secondary Outcome Measures :
  1. Weight loss [ Time Frame: 6 months and 12 months ]
  2. Physical activity [ Time Frame: 3 months, 6 months, 12 months ]
    Assessed by triaxial accelerometer and RPAQ questionnaire

  3. Blood pressure (Seated, systolic and diastolic mmHg) [ Time Frame: 3 months, 6 months, 12 months ]
    Seated, systolic and diastolic mmHg

  4. Biochemical markers of CVD risk [ Time Frame: 3 months, 6 months, 12 months ]
    Total cholesterol HDL cholesterol, LDL cholesterol, trihlycerides high-sensitivity CRP, HOMA, HbA1c

  5. Dietary intake [ Time Frame: 3 months, 6 months, 12 months ]
    Diet history

  6. Pulse wave analysis [ Time Frame: 3 months, 6 months, 12 months ]
    SpygmoCor Pulse Wave Analysis System

  7. Quality of life [ Time Frame: 3 months, 6 months, 12 months ]
    Questionnaire

  8. Sleep quality [ Time Frame: 3 months, 6 months, 12 months ]
    Questionnaire

  9. Self-esteem [ Time Frame: 3 months, 6 months, 12 months ]
    Questionnaire

  10. Self-efficacy [ Time Frame: 3 months, 6 months, 12 months ]
    Questionnaire

  11. Depression [ Time Frame: 3 months, 6 months, 12 months ]
    Questionnaire



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( Other Identifier: ORECNI )
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013

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

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms