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

Obesity Clinical Trial

— ACTION Teens  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05013359
• Other study ID #: DAS-003
• Secondary ID: U1111-1262-1190
• Status: Completed
• Start date: August 23, 2021
• Est. completion date: December 13, 2021

Study information

• Verified date: January 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12987
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• No treatment given
No treatment given

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Sydney
Colombia	Novo Nordisk Investigational Site	Bogotá
Italy	Novo Nordisk Investigational Site	Rome
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Mexico	Novo Nordisk Investigational Site	Mexico City
Saudi Arabia	Novo Nordisk Investigational Site	Riyadh
Spain	Novo Nordisk Investigational Site	Madrid
Taiwan	Novo Nordisk Investigational Site	Taipei
Turkey	Novo Nordisk Investigational Site	Istanbul
United Kingdom	Novo Nordisk Investigational Site	Gatwick

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Australia,  Colombia,  Italy,  Korea, Republic of,  Mexico,  Saudi Arabia,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)