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Completed

NCT Number: NCT01472276

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

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.

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Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Queen's University Belfast

Belfast, Antrim, BT12 6BJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based program

Behavioral

Provided with the web-based program

Primary outcomes

  1. Weight Loss Kg

    Time frame: 3 months

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

Secondary outcomes

  1. Weight Loss

    Time frame: 6 months and 12 months

    Between-group change in weight loss at 6 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, triglycerides 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

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • AXA PPP Healthcare

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 16, 2011
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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