NCT05013359

Brief 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. 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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,987

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
10 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

August 23, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2021

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

August 6, 2021

Last Update Submit

February 1, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    At the time of survey response (Day 1)

  • 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.

    At the time of survey response (Day 1)

  • 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

    At the time of survey response (Day 1)

  • 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

    At the time of survey response (Day 1)

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

    Multi-select from defined list

    At the time of survey response (Day 1)

Study Arms (3)

Adolescents Living with Obesity (ALwO)

Recruited from online, general population consumer panels

Other: No treatment given

Health Care Providers (HCPs)

HCPs treating adolescents who have obesity

Other: No treatment given

Caregivers

A parent or legal guardian of an adolescent with obesity

Other: No treatment given

Interventions

No treatment given

Adolescents Living with Obesity (ALwO)CaregiversHealth Care Providers (HCPs)

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.
  • 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.
  • 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.
  • +2 more criteria

You may not qualify if:

  • 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.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Novo Nordisk Investigational Site

Sydney, NSW 2060, Australia

Location

Novo Nordisk Investigational Site

Bogotá, 110111, Colombia

Location

Novo Nordisk Investigational Site

Rome, 00144, Italy

Location

Novo Nordisk Investigational Site

Mexico City, 11560, Mexico

Location

Novo Nordisk Investigational Site

Riyadh, 13315, Saudi Arabia

Location

Novo Nordisk Investigational Site

Seoul, 05510, South Korea

Location

Novo Nordisk Investigational Site

Madrid, 28033, Spain

Location

Novo Nordisk Investigational Site

Taipei, 106, Taiwan

Location

Novo Nordisk Investigational Site

Istanbul, 34335, Turkey (Türkiye)

Location

Novo Nordisk Investigational Site

Gatwick, RH6 0PA, United Kingdom

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Transparency (dept. 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 19, 2021

Study Start

August 23, 2021

Primary Completion

December 13, 2021

Study Completion

December 13, 2021

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

More information

Locations