Metabolism and Nutrition DisorderNCT03235102
Awareness, Care and Treatment in Obesity Management
An observational study of Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 1 site in Canada.
Trial summary
This study aims to assess barriers that prevent obesity patients from receiving adequate care for their condition. The non-interventional study will be administered in the form of a 30-minute, cross-sectional, online survey to various respondents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- What is being tested?
- No treatment given
- How many people
- 2,545 participants
- Where
- 1 siteCanada
- Study dates
- 3 Aug 2017to 11 Oct 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All respondents will be recruited from the OMR Globus healthcare panel (http://www.omrglobus.com/). The OMR Globus panel is an opt-in panel, in which respondents join with the understanding they would complete periodic surveys. Members of this panel are not associated with any specific site or organization. Recruitment of these respondents is based on voluntary participation; invitations are sent to the personal e-mail accounts of each respondent.
Who may be able to join
- The following inclusion criteria will be imposed for HCPs:
- Practice in Canada
- Spends at least 70% of time in direct patient care
- Seen at least 100 patients in past month
- Seen at least 10 patients in past month needing weight management
- In practice 2-35 years
Show all 28Show fewer
- Not affiliated with Pharmaceutical, Market Research (MR) or Advertising Firms
- PCP - Physician, RN / NP / LPN, or PA, Dietitians
- PCP - Specialty is FP, IM, GP
- Obesity Specialist - Physician, RN / NP / LPN, or PA
- Obesity Specialist - Specialty is FP, IM, GP, endocrinology, bariatrics, or bariatric surgery
- Obesity Specialist - Currently practice as an obesity medicine or weight loss management specialist
- The following inclusion criteria will be imposed for PwOs (people with obesity):
- Age at least 18 years
- Lives in Canada
- Recruitment will target a nationally representative Canada sample. Demographic indicators will be monitored throughout recruitment.
- Current BMI 30 kg/sqm or greater, not extremely fit/body building
- Sub-category - Maintaining weight loss: Lost at least 10% of body weight in the past 3 years and has kept weight off for at least a year
- Sub-category - Treatment Seeking: Has committed to a plan to lose weight, or has successfully lost weight (self-report) or has spoken to an HCP about weight loss plan in the last 6 months.
- The following inclusion criteria will be imposed for employers:
- Age at least 18 years
- Works in a Canadian province
- Company offers health insurance
- Responsible for making or influencing decisions about health insurance or health and wellness programs
- Works in a company that has 20 or more employees
- Believes there is a weight issue (attitudinal agreement)
- Not affiliated with Pharmaceutical, Market Research (MR) or Advertising Firms
- Exclusion criteria Any respondent who work works for a pharmaceutical, health insurance, research, or advertising company will be excluded; as there may be self-presentation effects that could alter the interview questions.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obesity ACTION Study in Canada
This study aims to assess barriers that prevent obesity patients from receiving adequate care for their condition. The non-interventional study will be administered in the form of a 30-minute, cross-sectional, online survey to various respondents. There is no experimentation involved in the process of data collection, and each survey poses minimal human risk.
The study will evaluate lifestyle habits and weight management strategies perceived and/or practiced by each of 3 stakeholders in obesity: Patients (People with obesity), Providers, and Employers. A customized survey will be administered to each of the 3 stakeholders, and data will be analyzed based on respondents' answers.
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- No treatment given
- Medical subject headings
- Nutrition Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
Completion of a survey
| Study group | Role | What they receive |
|---|---|---|
| People with Obesity | People with obesity, or weight loss patients. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey. Receives: Other: No treatment given | |
| Healthcare Providers | PCPs will include family practitioners; general practitioners; internal medicine; nurse practitioners; and dietitians. Specialists will include endocrinologists and bariatric surgeons, and any of the above if they focus on obesity treatment. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey. Receives: Other: No treatment given | |
| Employers | Employers in Canada. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey. Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness associated with the care and management of obesity among people with obesity, clinicians and employers
Cross-sectional 30-minute online survey of lifestyle habits and weight management conducted among stakeholders in obesity (clinicians, employers and people with obesity)
Measured: From the first interview on day 1 until the last interview on day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start3 Aug 2017
- Primary completion11 Oct 2017
- Study completion11 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolism and Nutrition DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235102
- Sponsor's protocol ID
- INS-4411
- Other IDs
- U1111-1199-1902
- Status last verified
- Jul 2019
- First submitted
- 27 Jul 2017
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Sharma AM, Belanger A, Carson V, Krah J, Langlois MF, Lawlor D, Lepage S, Liu A, Macklin DA, MacKay N, Pakseresht A, Pedersen SD, Ramos Salas X, Vallis M. Perceptions of barriers to effective obesity management in Canada: Results from the ACTION study. Clin Obes. 2019 Oct;9(5):e12329. doi: 10.1111/cob.12329. Epub 2019 Jul 11.
PubMed 31294535
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity ACTION Study in Canada
- ClinicalTrials.gov ID
- NCT03235102
- Acronym / sponsor ID
- INS-4411
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,545 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 11 Oct 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 1 Aug 2017 (actual)
- 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 study aims to assess barriers that prevent obesity patients from receiving adequate care for their condition. The non-interventional study will be administered in the form of a 30-minute, cross-sectional, online survey to various respondents. There is no experimentation involved in the process of data collection, and each survey poses minimal human risk.
The study will evaluate lifestyle habits and weight management strategies perceived and/or practiced by each of 3 stakeholders in obesity: Patients (People with obesity), Providers, and Employers. A customized survey will be administered to each of the 3 stakeholders, and data will be analyzed based on respondents' answers.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| People with Obesity | – | Other: No treatment givenPeople with obesity, or weight loss patients. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey. |
| Healthcare Providers | – | Other: No treatment givenPCPs will include family practitioners; general practitioners; internal medicine; nurse practitioners; and dietitians. Specialists will include endocrinologists and bariatric surgeons, and any of the above if they focus on obesity treatment. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey. |
| Employers | – | Other: No treatment givenEmployers in Canada. Potential respondents will be recruited from various Internet patient panels to participate in a cross-sectional, online survey. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All respondents will be recruited from the OMR Globus healthcare panel (http://www.omrglobus.com/). The OMR Globus panel is an opt-in panel, in which respondents join with the understanding they would complete periodic surveys. Members of this panel are not associated with any specific site or organization. Recruitment of these respondents is based on voluntary participation; invitations are sent to the personal e-mail accounts of each respondent.
Key inclusion criteria (28 listed)
- Practice in Canada
- Spends at least 70% of time in direct patient care
- Seen at least 100 patients in past month
- Seen at least 10 patients in past month needing weight management
- In practice 2-35 years
Key exclusion criteria (0 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 |
|---|---|---|
| No treatment givenCompletion of a survey | Other | Employers, Healthcare Providers, People with Obesity |
Primary outcome
Awareness associated with the care and management of obesity among people with obesity, clinicians and employers
Time frame: From the first interview on day 1 until the last interview on day 30
Cross-sectional 30-minute online survey of lifestyle habits and weight management conducted among stakeholders in obesity (clinicians, employers and people with obesity)
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 19 Jul 2019.
- Results publication: PubMed 31294535Sharma AM, Belanger A, Carson V, Krah J, Langlois MF, Lawlor D, Lepage S, Liu A, Macklin DA, MacKay N, Pakseresht A, Pedersen SD, Ramos Salas X, Vallis M. Perceptions of barriers to effective obesity management in Canada: Results from the ACTION study. Clin Obes. 2019 Oct;9(5):e12329. doi: 10.1111/cob.12329. Epub 2019 Jul 11.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S 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 28 inclusion and 0 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 19 Jul 2019. 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.
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?
Awareness associated with the care and management of obesity among people with obesity, clinicians and employers (time frame: From the first interview on day 1 until the last interview on day 30). 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 NCT03235102, 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 19 Jul 2019.