Clinical trial NCT05013359: Awareness, Care & Treatment In Obesity Management - An International Observation Among Teens (ACTION Teens)
Official title: Awareness, Care & Treatment In Obesity Management - An International Observation Among Teens (ACTION Teens)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-08-19
Enrollment: 12987
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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.

Primary outcomes:
measure: Attitudes about obesity, attitudes about people with obesity, and beliefs about the impact of obesity
timeFrame: At the time of survey response (Day 1)
measure: Weight loss attempts in past year, motivations to lose weight, barriers to losing weight, and definition of successful weight loss/management
timeFrame: At the time of survey response (Day 1)
measure: 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
timeFrame: At the time of survey response (Day 1)
measure: 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
timeFrame: At the time of survey response (Day 1)
measure: Sources of information used to learn about obesity, healthy lifestyles, weight loss, and weight management
timeFrame: At the time of survey response (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Novo Nordisk Investigational Site
city: Bogotá
country: Colombia
facility: Novo Nordisk Investigational Site
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Mexico City
country: Mexico
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Taipei
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Gatwick
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References:
citation: 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.