AzTrials
AzTrials

ObesityACTION TeensNCT05013359

Awareness, Care & Treatment In Obesity Management - An International Observation Among Teens (ACTION Teens)

An observational study of Obesity, run by Novo Nordisk A/S at 10 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

ACTION Teens is a multinational cross-sectional survey-based study. The study consists of a quantitative online survey to be conducted among three groups of respondents in ten countries worldwide. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Obesity
What is being tested?
No treatment given
How many people
12,987 participants
Where
10 sitesin 10 countries
Study dates
23 Aug 2021to 13 Dec 2021
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 12 years and older
  • All sexes
  • Child, Adult, Older adult

Study population: The respondent population will include Adolescents living with obesity (ALwO), Caregivers of ALwO, and HCPs treating adolescents who have obesity.

Who may be able to join

  • 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).
Show all 18Show fewer
  • 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.
  • 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).

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.
  • 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.

Trial locations and contacts

10 sites in 10 countries.

10 sites in 10 countries

Australia1 site
  • Novo Nordisk Investigational Site

    Sydney, NSW 2060

Other trials in Australia

Colombia1 site
  • Novo Nordisk Investigational Site

    Bogotá, 110111

Other trials in Colombia

Italy1 site
  • Novo Nordisk Investigational Site

    Rome, 00144

Other trials in Italy

Mexico1 site
  • Novo Nordisk Investigational Site

    Mexico City, 11560

Other trials in Mexico

Saudi Arabia1 site
  • Novo Nordisk Investigational Site

    Riyadh, 13315

Other trials in Saudi Arabia

South Korea1 site
  • Novo Nordisk Investigational Site

    Seoul, 05510

Other trials in South Korea

Spain1 site
  • Novo Nordisk Investigational Site

    Madrid, 28033

Other trials in Spain

Taiwan1 site
  • Novo Nordisk Investigational Site

    Taipei, 106

Other trials in Taiwan

Turkey (Türkiye)1 site
  • Novo Nordisk Investigational Site

    Istanbul, 34335

Other trials in Turkey (Türkiye)

United Kingdom1 site
  • Novo Nordisk Investigational Site

    Gatwick, RH6 0PA

Other trials in United Kingdom

About this study

ACTION Teens is a multinational cross-sectional survey-based study. The study consists of a quantitative online survey to be conducted among three groups of respondents in ten countries worldwide. The respondent population will include Adolescents Living with Obesity (ALwO), Caregivers of ALwO, and HCPs treating adolescents who have obesity.

The goal of this study is to provide insights to drive awareness around the needs of adolescents living with obesity and their caregivers, as well as to identify key areas of misalignment between adolescents, their caregivers and the HCPs involved in obesity treatment and management. ACTION Teens is designed to generate evidence to identify and address these challenges on both a global and local level, extending the insights from the previously conducted ACTION-IO study.

Conditions
Obesity
Being tested
No treatment given
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No treatment givenOther

    No treatment given

Study groups in NCT05013359
Study groupRoleWhat they receive
Adolescents Living with Obesity (ALwO)Recruited from online, general population consumer panels
Receives: Other: No treatment given
Health Care Providers (HCPs)HCPs treating adolescents who have obesity
Receives: Other: No treatment given
CaregiversA parent or legal guardian of an adolescent with obesity
Receives: Other: No treatment given

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Attitudes about obesity, attitudes about people with obesity, and beliefs about the impact of obesity

    5-point Likert scales (e.g., agreement, impact, frequency)

    • Proportion of responses in each category will be reported.

    Measured: At the time of survey response (Day 1)

  2. Weight loss attempts in past year, motivations to lose weight, barriers to losing weight, and definition of successful weight loss/management

    Yes/No; percentage of participants

    Multi-select from defined list

    • Percentage of respondents selecting an item or items will be reported.

    Measured: At the time of survey response (Day 1)

  3. 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

    Numeric entry; percentage of participants Single select from defined list; percentage of time each initiates Single select from defined list

    Measured: At the time of survey response (Day 1)

  4. 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

    5-point Likert scales Multi-select from defined list Yes/No; percentage of patients Yes/No; percentage of patients

    Measured: At the time of survey response (Day 1)

  5. Sources of information used to learn about obesity, healthy lifestyles, weight loss, and weight management

    Multi-select from defined list

    Measured: At the time of survey response (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2021
  2. Study start23 Aug 2021
  3. Primary completion13 Dec 2021
  4. Study completion13 Dec 2021

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
12,987 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05013359
Sponsor's protocol ID
DAS-003
Other IDs
U1111-1262-1190
Acronym
ACTION Teens
Status last verified
Jan 2022
First submitted
6 Aug 2021
Last updated
2 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Kwok C, Bentley N, Curran J, Lister N, Truby H, Baur LA. Misaligned Attitudes and Perceptions Among Adolescents Living With Obesity, Caregivers and Healthcare Professionals: ACTION Teens Australia Survey Study. J Paediatr Child Health. 2025 Oct;61(10):1573-1581. doi: 10.1111/jpc.70146. Epub 2025 Jul 14.

    PubMed 40657891
  • Halford JCG, Brown A, Clare K, Ells LJ, Ghosh A, Giri D, Hughes C, Senniappan S. Insights from the ACTION Teens Study: a survey of adolescents living with obesity, their caregivers and healthcare professionals in the UK. BMJ Open. 2024 Jul 23;14(7):e086391. doi: 10.1136/bmjopen-2024-086391.

    PubMed 39043586
  • Maffeis C, Busetto L, Wasniewska M, Di Pauli D, Maccora C, Lenzi A. Perceptions, attitudes, and behaviors among adolescents living with obesity, caregivers, and healthcare professionals in Italy: the ACTION Teens study. Eat Weight Disord. 2024 May 8;29(1):35. doi: 10.1007/s40519-024-01663-7.

    PubMed 38717596
  • Mooney V, Baur LA, Bereket A, Bin-Abbas B, Chen W, Fernandez-Aranda F, Nieto NG, Lopez Siguero JP, Maffeis C, Osorto CK, Reynoso R, Rhie YJ, Toro-Ramos M, Halford JC. The views of teenagers with obesity, their caregivers, and doctors: a plain language summary of the ACTION Teens global survey. J Comp Eff Res. 2023 Jan;12(1):e220164. doi: 10.2217/cer-2022-0164. Epub 2022 Oct 20.

    PubMed 36264113

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Novo Nordisk A/S at 10 sites in 10 countries.

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 18 inclusion and 11 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 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Australia, Colombia, Italy, Mexico, Saudi Arabia and 5 more countries. 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?

Attitudes about obesity, attitudes about people with obesity, and beliefs about the impact of obesity (time frame: At the time of survey response (Day 1)). The study lists 5 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 NCT05013359, 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 2 Feb 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in