- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03223493
Awareness, Care & Treatment in Obesity Management (ACTION) Study (ACTION)
July 17, 2019 updated by: Novo Nordisk A/S
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
3767
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Honeoye Falls, New York, United States, 14472
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Completion of a questionnaire
|
|
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
|
Completion of a questionnaire
|
|
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
|
Completion of a questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Start of interviews day 1 until day 15
|
|
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
|
Start of interviews day 1 until day 15
|
|
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
|
Start of interviews day 1 until day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Jinnett 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.
- Look 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.
- Dhurandhar 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 29, 2015
Primary Completion (Actual)
November 12, 2015
Study Completion (Actual)
November 12, 2015
Study Registration Dates
First Submitted
July 18, 2017
First Submitted That Met QC Criteria
July 18, 2017
First Posted (Actual)
July 21, 2017
Study Record Updates
Last Update Posted (Actual)
July 19, 2019
Last Update Submitted That Met QC Criteria
July 17, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INS-4409
- U1111-1198-9657 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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