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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472276
• Other study ID #: 10041MMcK-OPMS
• Secondary ID: 10/NIR02/28
• Status: Completed
• Phase: Phase 2
• Start date: April 2011
• Est. completion date: March 2013

Study information

• Verified date: June 2022
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Web-based program
Provided with the web-based program

Locations

Country	Name	City	State
United Kingdom	Queen's University Belfast	Belfast	Antrim

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University, Belfast	AXA PPP Healthcare

Country where clinical trial is conducted

United Kingdom, 

Outcome

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