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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05013359




Registration number
NCT05013359
Ethics application status
Date submitted
6/08/2021
Date registered
19/08/2021

Titles & IDs
Public title
Awareness, Care & Treatment In Obesity Management - An International Observation Among Teens (ACTION Teens)
Scientific title
Awareness, Care & Treatment In Obesity Management - An International Observation Among Teens (ACTION Teens)
Secondary ID [1] 0 0
U1111-1262-1190
Secondary ID [2] 0 0
DAS-003
Universal Trial Number (UTN)
Trial acronym
ACTION Teens
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No treatment given

Adolescents Living with Obesity (ALwO) - Recruited from online, general population consumer panels

Health Care Providers (HCPs) - HCPs treating adolescents who have obesity

Caregivers - A parent or legal guardian of an adolescent with obesity


Other interventions: No treatment given
No treatment given
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Attitudes about obesity, attitudes about people with obesity, and beliefs about the impact of obesity
Timepoint [1] 0 0
At the time of survey response (Day 1)
Primary outcome [2] 0 0
Weight loss attempts in past year, motivations to lose weight, barriers to losing weight, and definition of successful weight loss/management
Timepoint [2] 0 0
At the time of survey response (Day 1)
Primary outcome [3] 0 0
History and frequency of conversations about weight, initiator of weight conversations, and responsibility for initiating weight conversations that occur between adolescents living with obesity/their caregivers and healthcare providers
Timepoint [3] 0 0
At the time of survey response (Day 1)
Primary outcome [4] 0 0
Assessment of interactions between adolescents living with obesity/their caregivers and healthcare providers, reasons why obesity may not be discussed, frequency of obesity diagnosis, and frequency of follow-up appointments made to discuss obesity
Timepoint [4] 0 0
At the time of survey response (Day 1)
Primary outcome [5] 0 0
Sources of information used to learn about obesity, healthy lifestyles, weight loss, and weight management
Timepoint [5] 0 0
At the time of survey response (Day 1)

Eligibility
Key inclusion criteria
Inclusion Criteria for Adolescents living with obesity:

* Informed consent obtained by parent/legal guardian and ALwO before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male or female, aged 12 to less than 18 years at the time of signing informed consent.
* Lives in one of the participating countries: Italy, Spain, UK, Mexico, Colombia, Australia, Saudi Arabia, Turkey, South Korea, and Taiwan.
* Has a current BMI-for-age (based on self-reported sex, age, height, and weight) greater than or equal to 95th percentile for age and sex based on charts appropriate locally for the country of residence.

Inclusion Criteria for Caregivers of Adolescents living with obesity:

* Informed consent before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male or female, age above or equal to 24 years at the time of signing informed consent.
* Lives in one of the participating countries: Italy, Spain, UK, Mexico, Colombia, Australia, Saudi Arabia, Turkey, South Korea, and Taiwan.
* Has an adolescent in the household with a current BMI-for-age (based on self-reported sex, age, height, and weight) greater than or equal to 95th percentile for age and sex based on charts appropriate locally for the country of residence.
* Resides in the same household as the ALwO at least 50% of the time.
* Is involved in the healthcare decisions of the ALwO.

Inclusion Criteria for Health Care Providers:

* Informed consent before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Is a physician.
* Practices in one of the participating countries: Italy, Spain, UK, Mexico, Colombia, Australia, Saudi Arabia, Turkey, South Korea, and Taiwan
* In clinical practice more than or equal to 2 years.
* Spends at least 50% of time in direct patient care.
* Has seen/treated at least ten adolescent patients (age 12 to less than 18 years) with obesity in a typical month (defined as BMI-for-age greater than or equal to 95th percentile for age and sex based on charts appropriate locally for the country of residence).
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for Adolescents living with obesity:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation.
* Has had significant weight loss or weight gain due to major injury or illness/condition (e.g., cancer, accident, pregnancy) in the past 6 months.
* Considers themselves to be extremely muscular.

Exclusion Criteria for Caregivers of Adolescents living with obesity:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation.
* ALwO they care for has had significant weight loss or weight gain due to major injury or illness/condition (e.g., cancer, accident, pregnancy) in the past 6 months.
* Considers the ALwO they care for to be extremely muscular.

Exclusion Criteria for Health Care Providers:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/12/2021
Sample size
Target
Accrual to date
Final
12987
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Sydney
Recruitment postcode(s) [1] 0 0
NSW 2060 - Sydney
Recruitment outside Australia
Country [1] 0 0
Colombia
State/province [1] 0 0
Bogotá
Country [2] 0 0
Italy
State/province [2] 0 0
Rome
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
Mexico
State/province [4] 0 0
Mexico City
Country [5] 0 0
Saudi Arabia
State/province [5] 0 0
Riyadh
Country [6] 0 0
Spain
State/province [6] 0 0
Madrid
Country [7] 0 0
Taiwan
State/province [7] 0 0
Taipei
Country [8] 0 0
Turkey
State/province [8] 0 0
Istanbul
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Gatwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05013359