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

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Novo Nordisk

Status

Completed

Conditions

Obesity

Treatments

Other: No treatment given

Study type

Observational

Funder types

Industry

Identifiers

NCT05013359
U1111-1262-1190 (Other Identifier)
DAS-003

Details and patient eligibility

About

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.

Enrollment

12,987 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

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.

Trial design

12,987 participants in 3 patient groups

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

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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