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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: No treatment given

• Study Type: Observational
• Enrollment (Actual): 12987

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia, NSW 2060
    • Novo Nordisk Investigational Site
• Colombia
  • Bogotá, Colombia, 110111
    • Novo Nordisk Investigational Site
• Italy
  • Rome, Italy, 00144
    • Novo Nordisk Investigational Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 05510
    • Novo Nordisk Investigational Site
• Mexico
  • Mexico City, Mexico, 11560
    • Novo Nordisk Investigational Site
• Saudi Arabia
  • Riyadh, Saudi Arabia, 13315
    • Novo Nordisk Investigational Site
• Spain
  • Madrid, Spain, 28033
    • Novo Nordisk Investigational Site
• Taiwan
  • Taipei, Taiwan, 106
    • Novo Nordisk Investigational Site
• Turkey
  • Istanbul, Turkey, 34335
    • Novo Nordisk Investigational Site
• United Kingdom
  • Gatwick, United Kingdom, RH6 0PA
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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).

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adolescents Living with Obesity (ALwO); Recruited from online, general population consumer panels	Other: No treatment given; No treatment given
Health Care Providers (HCPs); HCPs treating adolescents who have obesity	Other: No treatment given; No treatment given
Caregivers; A parent or legal guardian of an adolescent with obesity	Other: No treatment given; No treatment given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): December 13, 2021
• Study Completion (Actual): December 13, 2021

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: DAS-003; U1111-1262-1190 (Other Identifier: World Health Organization)

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 device product: No