OverweightPhase 4NCT02077075
MyHealthCheckup Wellness Program Among Canadian Forces Military Personnel
A Phase 4 study testing Web-based weight loss program and On-line health coaching in people with Overweight, run by McGill University at 1 site in Canada.
Trial summary
This research is collecting data to determine the benefits of a web-based wellness program designed to improve the health and well-being of individuals in the workplace. Participants will be invited to participate in a web-based Healthy Weight Program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight
- What is being tested?
- Web-based weight loss program and On-line health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Apr 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A military member of the Canadian Forces Base in Halifax
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of the MyHealthCheckup Wellness Program Among Canadian Forces Military Personnel
This research is collecting data to determine the benefits of a web-based wellness program designed to improve the health and well-being of individuals in the workplace. Participants will be invited to participate in a web-based Healthy Weight Program. The program is designed to optimize health and wellbeing by promoting physical activity and healthy eating.
- Conditions
- Overweight
- Being tested
- Web-based weight loss program, On-line health coaching
- Keywords
- weight loss, healthy weight, overweight, body mass index greater that 25 kg/m2
- Medical subject headings
- Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based weight loss programBehavioural
A 4-week web-based wellness program.
On-line health coachingBehavioural
A 4-week web-based wellness program with weekly personalized on-line health coaching.
| Study group | Role | What they receive |
|---|---|---|
| Web-based weight loss program | Active comparator | Subjects will have access to a web-based weight loss program for an 8-week period. Receives: Behavioral: Web-based weight loss program |
| On-line health coaching in addition to web-based program | Experimental | Subjects will have access to the web-based wellness program and will also receive weekly personalized health coaching emails. Receives: Behavioral: Web-based weight loss program; Behavioral: On-line health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body weight
Body weight
Measured: 4 weeks
Secondary outcomes (1)
Change in Waist circumference
Waist circumference measured at the umbilicus
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Grover, MD, McGill University
- Investigators
- Steven Grover, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077075
- Sponsor's protocol ID
- CHIP13001
- Status last verified
- Apr 2015
- First submitted
- 27 Feb 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the MyHealthCheckup Wellness Program Among Canadian Forces Military Personnel
- ClinicalTrials.gov ID
- NCT02077075
- Acronym / sponsor ID
- CHIP13001
- Conditions
- Overweight
- Keywords
- weight loss, healthy weight, overweight, body mass index greater that 25 kg/m2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is collecting data to determine the benefits of a web-based wellness program designed to improve the health and well-being of individuals in the workplace. Participants will be invited to participate in a web-based Healthy Weight Program. The program is designed to optimize health and wellbeing by promoting physical activity and healthy eating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based weight loss program | Active comparator | Behavioral: Web-based weight loss programSubjects will have access to a web-based weight loss program for an 8-week period. |
| On-line health coaching in addition to web-based program | Experimental | Behavioral: Web-based weight loss program, Behavioral: On-line health coachingSubjects will have access to the web-based wellness program and will also receive weekly personalized health coaching emails. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A military member of the Canadian Forces Base in Halifax
Key exclusion criteria (1 listed)
- -
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 weight loss programA 4-week web-based wellness program. | Behavioural | On-line health coaching in addition to web-based program, Web-based weight loss program |
| On-line health coachingA 4-week web-based wellness program with weekly personalized on-line health coaching. | Behavioural | On-line health coaching in addition to web-based program |
Primary outcome
Change in Body weight
Time frame: 4 weeks
Body weight
1 secondary outcome
Change in Waist circumference
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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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.
Steven Grover, MD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Web-based weight loss program and On-line health coaching in people with Overweight, run by McGill University at 1 site in Canada.
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 1 inclusion and 1 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 8 Apr 2015. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Body weight (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2015.