ObesityPhase 2NCT01472276
Effect of a Unique Web-based Behaviour Change Program on Weight Loss and Cardiovascular Risk Factors
A Phase 2 study testing Web-based program in people with Obesity, run by Queen's University, Belfast at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Web-based program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Major health problems including Type 1 diabetes, established CVD, renal and hepatic disease
- Psychiatric problems
- Pregnancy
- Excessive alcohol consumption
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's University Belfast
Belfast, Antrim, BT12 6BJ
About this study
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
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
- Being tested
- Web-based program
- Keywords
- Behaviour change, Weight loss, Cardiovascular risk, Diet, Physical activity, Overweight, Obesity, Internet
- Medical subject headings
- Obesity, Weight Loss, Motor Activity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based programBehavioural
Provided with the web-based program
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Web-based program | Active comparator | Not described Receives: Behavioral: Web-based program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss Kg
Between-group change in weight loss at 3-month follow-up
Measured: 3 months
Secondary outcomes (11)
Weight Loss
Between-group change in weight loss at 6 and 12 months
Measured: 6 months and 12 months
Physical Activity
Assessed by triaxial accelerometer and RPAQ questionnaire
Measured: 3 months, 6 months, 12 months
Blood Pressure (Seated, Systolic and Diastolic mmHg)
Seated, systolic and diastolic mmHg
Measured: 3 months, 6 months, 12 months
Biochemical Markers of CVD Risk
Total cholesterol HDL cholesterol, LDL cholesterol, triglycerides high-sensitivity CRP, HOMA, HbA1c
Measured: 3 months, 6 months, 12 months
Dietary Intake
Diet history
Measured: 3 months, 6 months, 12 months
Pulse Wave Analysis
SpygmoCor Pulse Wave Analysis System
Measured: 3 months, 6 months, 12 months
Quality of Life
Questionnaire
Measured: 3 months, 6 months, 12 months
Sleep Quality
Questionnaire
Measured: 3 months, 6 months, 12 months
Self-esteem
Questionnaire
Measured: 3 months, 6 months, 12 months
Self-efficacy
Questionnaire
Measured: 3 months, 6 months, 12 months
Depression
Questionnaire
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- AXA PPP Healthcare
- Responsible party
- Principal investigator, Michelle McKinley, Queen's University, Belfast
- Investigators
- Michelle McKinley, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472276
- Sponsor's protocol ID
- 10041MMcK-OPMS
- Other IDs
- 10/NIR02/28
- Status last verified
- Jun 2022
- First submitted
- 9 Nov 2011
- Last updated
- 1 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26183659
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01472276
- Acronym / sponsor ID
- 10041MMcK-OPMS
- Conditions
- Obesity
- Keywords
- Behaviour change, Weight loss, Cardiovascular risk, Diet, Physical activity, Overweight, Obesity, Internet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- AXA PPP Healthcare
- Study start
- Apr 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Posted 1 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Web-based program | Active comparator | Behavioral: Web-based program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Major health problems including Type 1 diabetes, established CVD, renal and hepatic disease
- Psychiatric problems
- Pregnancy
- Excessive alcohol consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based programProvided with the web-based program | Behavioural | Web-based program |
Primary outcome
Weight Loss Kg
Time frame: 3 months
Between-group change in weight loss at 3-month follow-up
11 secondary outcomes
Weight Loss
Time frame: 6 months and 12 months
Physical Activity
Time frame: 3 months, 6 months, 12 months
Blood Pressure (Seated, Systolic and Diastolic mmHg)
Time frame: 3 months, 6 months, 12 months
Biochemical Markers of CVD Risk
Time frame: 3 months, 6 months, 12 months
Dietary Intake
Time frame: 3 months, 6 months, 12 months
Pulse Wave Analysis
Time frame: 3 months, 6 months, 12 months
Quality of Life
Time frame: 3 months, 6 months, 12 months
Sleep Quality
Time frame: 3 months, 6 months, 12 months
Self-esteem
Time frame: 3 months, 6 months, 12 months
Self-efficacy
Time frame: 3 months, 6 months, 12 months
Depression
Time frame: 3 months, 6 months, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26183659Watson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle McKinley, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Web-based program in people with Obesity, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss Kg (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01472276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.