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

NCT01472276 | Completed Phase 2 Results

• 2 other identifiers: 10041MMcK-OPMS10/NIR02/28
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Behaviour change; Weight loss; Cardiovascular risk; Diet; Physical activity; Overweight; Obesity; Internet

Outcome Measures

Primary Outcomes (1)

• Weight Loss Kg

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

  3 months

Secondary Outcomes (11)

• Weight Loss

  6 months and 12 months

• Physical Activity

  3 months, 6 months, 12 months

• Blood Pressure (Seated, Systolic and Diastolic mmHg)

  3 months, 6 months, 12 months

• Biochemical Markers of CVD Risk

  3 months, 6 months, 12 months

• Dietary Intake

  3 months, 6 months, 12 months

Study Arms (2)

Control

NO INTERVENTION

Web-based program

ACTIVE COMPARATOR

Behavioral: Web-based program

Interventions

Web-based program BEHAVIORAL

Provided with the web-based program

Web-based program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major health problems including Type 1 diabetes, established CVD, renal and hepatic disease
• Psychiatric problems
• Pregnancy
• Excessive alcohol consumption

Sponsors & Collaborators

• Queen's University, Belfast: lead
• AXA PPP Healthcare: collaborator

Study Sites (1)

Queen's University Belfast

Belfast, Antrim, BT12 6BJ, United Kingdom

Location

Related Publications (1)

• Watson S, Woodside JV, Ware LJ, Hunter SJ, McGrath A, Cardwell CR, Appleton KM, Young IS, McKinley MC. Effect of a Web-Based Behavior Change Program on Weight Loss and Cardiovascular Risk Factors in Overweight and Obese Adults at High Risk of Developing Cardiovascular Disease: Randomized Controlled Trial. J Med Internet Res. 2015 Jul 16;17(7):e177. doi: 10.2196/jmir.3828.

  PMID: 26183659 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Motor Activity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Results Point of Contact

• Title: Michelle McKinley, Professor
• Organization: Queen's University, Belfast

m.mckinley@qub.ac.uk

02890978936

Study Officials

• Michelle McKinley, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 16, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 1, 2023
• Results First Posted: May 1, 2023

Record last verified: 2022-06

Locations

GB (1)