Metabolism and Nutrition DisorderACTIONNCT03223493
Awareness, Care & Treatment in Obesity Management (ACTION) Study
An observational study of Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
The ACTION (Awareness, Care, and Treatment In Obesity management) study aims to identify perceptions, attitudes, behaviours, and potential barriers to effective obesity care across three respondent types: 1) People with Obesity, 2) Healthcare Providers and 3) Employer Representatives in the US. 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
- 3,767 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2015to 12 Nov 2015
- 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
Who may be able to join
- GENERAL POPULATION
- Agrees to AE reporting
- Age at least 18 years
- Lives in the US
- Current BMI at least 30 kg/sqm
- HEALTH CARE PROFESSIONALS
Show all 28Show fewer
- Agrees to AE reporting
- Physician and board certified or NP/PA
- Facility located in the U.S. and not Vermont
- 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
- Not competitively employed
- Primary Care Providers
- Specialty is FP, IM, GP
- Less than 50% patients seen for obesity
- Obesity Specialists
- Obesity medicine or weight loss specialist or at least 50% of patients seen for obesity
- In practice 2-35 years
- EMPLOYERS
- Age at least 18 years
- Works in the US
- Director, Administrator, CHRO, VP or other title
- Responsible for making or influencing decisions about health insurance or health and wellness programs
- Company employs 500 or more full-time employees
- Believes there is a weight issue at their company
- Not competitively employed
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Honeoye Falls, New York, 14472
About this study
The ACTION (Awareness, Care, and Treatment In Obesity management) study aims to identify perceptions, attitudes, behaviours, and potential barriers to effective obesity care across three respondent types: 1) People with Obesity, 2) Healthcare Providers and 3) Employer Representatives in the US. Data is collected via online surveys using a cross-sectional, US-based stratified sample design.
- 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 questionnaire
| Study group | Role | What they receive |
|---|---|---|
| People with Obesity | General population, respondents are recruited via email and/or phone through an online panel company with which respondents have provided permission to be contacted for research Receives: Other: No treatment given | |
| Healthcare Providers | Health care professionals, respondents will be recruited via email, USPS mail, and/or phone through an online panel company with which respondents have provided permission to be contacted for research purposes or through the AMA Masterfile Receives: Other: No treatment given | |
| Employer representatives | Employers, respondents will be recruited via email, USPS mail, and/or phone through an online panel company with which respondents have provided permission to be contacted for research purposes Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness with the care and management of obesity among people with obesity
Data is collected via online questionnaires using a cross-sectional, US-based stratified sample design
Measured: Start of interviews day 1 until day 15
Awareness with the care and management of obesity among health care providers
Data is collected via online questionnaires using a cross-sectional, US-based stratified sample design
Measured: Start of interviews day 1 until day 15
Awareness with the care and management of obesity among employer representatives
Data is collected via online questionnaires using a cross-sectional, US-based stratified sample design
Measured: Start of interviews day 1 until day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start29 Oct 2015
- Primary completion12 Nov 2015
- Study completion12 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 3,767 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
- NCT03223493
- Sponsor's protocol ID
- INS-4409
- Other IDs
- U1111-1198-9657
- Acronym
- ACTION
- Status last verified
- Jul 2019
- First submitted
- 18 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
Kaplan LM, Golden A, Jinnett K, Kolotkin RL, Kyle TK, Look M, Nadglowski J, O'Neil PM, Parry T, Tomaszewski KJ, Stevenin B, Lilleore SK, Dhurandhar NV. Perceptions of Barriers to Effective Obesity Care: Results from the National ACTION Study. Obesity (Silver Spring). 2018 Jan;26(1):61-69. doi: 10.1002/oby.22054. Epub 2017 Oct 31.
PubMed 29086529Jinnett K, Kyle T, Parry T, Stevenin B, Ramasamy A; ACTION Steering Group. Insights into the Role of Employers Supporting Obesity Management in People with Obesity: Results of the National ACTION Study. Popul Health Manag. 2019 Aug;22(4):308-314. doi: 10.1089/pop.2018.0133. Epub 2018 Oct 31.
PubMed 30383482Look M, Kolotkin RL, Dhurandhar NV, Nadglowski J, Stevenin B, Golden A. Implications of differing attitudes and experiences between providers and persons with obesity: results of the national ACTION study. Postgrad Med. 2019 Jun;131(5):357-365. doi: 10.1080/00325481.2019.1620616. Epub 2019 Jun 3.
PubMed 31155994Dhurandhar NV, Kyle T, Stevenin B, Tomaszewski K; ACTION Steering Group. Predictors of weight loss outcomes in obesity care: results of the national ACTION study. BMC Public Health. 2019 Oct 30;19(1):1422. doi: 10.1186/s12889-019-7669-1.
PubMed 31666040
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
- Awareness, Care & Treatment in Obesity Management (ACTION) Study
- ClinicalTrials.gov ID
- NCT03223493
- Acronym / sponsor ID
- ACTION / INS-4409
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,767 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2015 (actual)
- Primary completion
- 12 Nov 2015 (actual)
- Study completion
- 12 Nov 2015 (actual)
- First posted
- 21 Jul 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.
The ACTION (Awareness, Care, and Treatment In Obesity management) study aims to identify perceptions, attitudes, behaviours, and potential barriers to effective obesity care across three respondent types: 1) People with Obesity, 2) Healthcare Providers and 3) Employer Representatives in the US. Data is collected via online surveys using a cross-sectional, US-based stratified sample design.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| People with Obesity | – | Other: No treatment givenGeneral population, respondents are recruited via email and/or phone through an online panel company with which respondents have provided permission to be contacted for research |
| Healthcare Providers | – | Other: No treatment givenHealth care professionals, respondents will be recruited via email, USPS mail, and/or phone through an online panel company with which respondents have provided permission to be contacted for research purposes or through the AMA Masterfile |
| Employer representatives | – | Other: No treatment givenEmployers, respondents will be recruited via email, USPS mail, and/or phone through an online panel company with which respondents have provided permission to be contacted for research purposes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (28 listed)
- GENERAL POPULATION
- Agrees to AE reporting
- Age at least 18 years
- Lives in the US
- Current BMI at least 30 kg/sqm
Key exclusion criteria (1 listed)
- None
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 questionnaire | Other | Employer representatives, Healthcare Providers, People with Obesity |
Primary outcome
Awareness with the care and management of obesity among people with obesity
Time frame: Start of interviews day 1 until day 15
Data is collected via online questionnaires using a cross-sectional, US-based stratified sample design
Awareness with the care and management of obesity among health care providers
Time frame: Start of interviews day 1 until day 15
Data is collected via online questionnaires using a cross-sectional, US-based stratified sample design
Awareness with the care and management of obesity among employer representatives
Time frame: Start of interviews day 1 until day 15
Data is collected via online questionnaires using a cross-sectional, US-based stratified sample design
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 29086529Kaplan LM, Golden A, Jinnett K, Kolotkin RL, Kyle TK, Look M, Nadglowski J, O'Neil PM, Parry T, Tomaszewski KJ, Stevenin B, Lilleore SK, Dhurandhar NV. Perceptions of Barriers to Effective Obesity Care: Results from the National ACTION Study. Obesity (Silver Spring). 2018 Jan;26(1):61-69. doi: 10.1002/oby.22054. Epub 2017 Oct 31.
- Results publication: PubMed 30383482Jinnett K, Kyle T, Parry T, Stevenin B, Ramasamy A; ACTION Steering Group. Insights into the Role of Employers Supporting Obesity Management in People with Obesity: Results of the National ACTION Study. Popul Health Manag. 2019 Aug;22(4):308-314. doi: 10.1089/pop.2018.0133. Epub 2018 Oct 31.
- Results publication: PubMed 31155994Look M, Kolotkin RL, Dhurandhar NV, Nadglowski J, Stevenin B, Golden A. Implications of differing attitudes and experiences between providers and persons with obesity: results of the national ACTION study. Postgrad Med. 2019 Jun;131(5):357-365. doi: 10.1080/00325481.2019.1620616. Epub 2019 Jun 3.
- Derived from this study: PubMed 31666040Dhurandhar NV, Kyle T, Stevenin B, Tomaszewski K; ACTION Steering Group. Predictors of weight loss outcomes in obesity care: results of the national ACTION study. BMC Public Health. 2019 Oct 30;19(1):1422. doi: 10.1186/s12889-019-7669-1.
- 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 United States.
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 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 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 United States. 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 with the care and management of obesity among people with obesity (time frame: Start of interviews day 1 until day 15). The study lists 3 primary outcomes in all. 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 NCT03223493, which also lists 4 linked publications.
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.