Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT05013359
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2021-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Awareness, Care & Treatment In Obesity Management - An International Observation Among Teens (ACTION Teens)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12987}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2021-08-06', 'studyFirstSubmitQcDate': '2021-08-12', 'lastUpdatePostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': '5-point Likert scales (e.g., agreement, impact, frequency)\n\n\\- Proportion of responses in each category will be reported.'}, {'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)', 'description': 'Yes/No; percentage of participants\n\nMulti-select from defined list\n\n\\- Percentage of respondents selecting an item or items will be reported.'}, {'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)', 'description': 'Numeric entry; percentage of participants Single select from defined list; percentage of time each initiates Single select from defined list'}, {'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)', 'description': '5-point Likert scales Multi-select from defined list Yes/No; percentage of patients Yes/No; percentage of patients'}, {'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)', 'description': 'Multi-select from defined list'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '40657891', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39043586', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38717596', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '36264113', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The respondent population will include Adolescents living with obesity (ALwO), Caregivers of ALwO, and HCPs treating adolescents who have obesity.', 'eligibilityCriteria': 'Inclusion Criteria for Adolescents living with obesity:\n\n* 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).\n* Male or female, aged 12 to less than 18 years at the time of signing informed consent.\n* Lives in one of the participating countries: Italy, Spain, UK, Mexico, Colombia, Australia, Saudi Arabia, Turkey, South Korea, and Taiwan.\n* 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.\n\nInclusion Criteria for Caregivers of Adolescents living with obesity:\n\n* Informed consent before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).\n* Male or female, age above or equal to 24 years at the time of signing informed consent.\n* Lives in one of the participating countries: Italy, Spain, UK, Mexico, Colombia, Australia, Saudi Arabia, Turkey, South Korea, and Taiwan.\n* 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.\n* Resides in the same household as the ALwO at least 50% of the time.\n* Is involved in the healthcare decisions of the ALwO.\n\nInclusion Criteria for Health Care Providers:\n\n* Informed consent before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).\n* Male or female, age above or equal to 18 years at the time of signing informed consent.\n* Is a physician.\n* Practices in one of the participating countries: Italy, Spain, UK, Mexico, Colombia, Australia, Saudi Arabia, Turkey, South Korea, and Taiwan\n* In clinical practice more than or equal to 2 years.\n* Spends at least 50% of time in direct patient care.\n* 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).\n\nExclusion Criteria for Adolescents living with obesity:\n\n* Previous participation in this study. Participation is defined as having given informed consent in this study.\n* Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation.\n* 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.\n* Considers themselves to be extremely muscular.\n\nExclusion Criteria for Caregivers of Adolescents living with obesity:\n\n* Previous participation in this study. Participation is defined as having given informed consent in this study.\n* Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation.\n* 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.\n* Considers the ALwO they care for to be extremely muscular.\n\nExclusion Criteria for Health Care Providers:\n\n* Previous participation in this study. Participation is defined as having given informed consent in this study.\n* Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation.'}, 'identificationModule': {'nctId': 'NCT05013359', 'acronym': 'ACTION Teens', 'briefTitle': 'Awareness, Care & Treatment In Obesity Management - An International Observation Among Teens (ACTION Teens)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Awareness, Care & Treatment In Obesity Management - An International Observation Among Teens (ACTION Teens)', 'orgStudyIdInfo': {'id': 'DAS-003'}, 'secondaryIdInfos': [{'id': 'U1111-1262-1190', 'type': 'OTHER', 'domain': 'World Health Organization'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adolescents Living with Obesity (ALwO)', 'description': 'Recruited from online, general population consumer panels', 'interventionNames': ['Other: No treatment given']}, {'label': 'Health Care Providers (HCPs)', 'description': 'HCPs treating adolescents who have obesity', 'interventionNames': ['Other: No treatment given']}, {'label': 'Caregivers', 'description': 'A parent or legal guardian of an adolescent with obesity', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'No treatment given', 'armGroupLabels': ['Adolescents Living with Obesity (ALwO)', 'Caregivers', 'Health Care Providers (HCPs)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NSW 2060', 'city': 'Sydney', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '110111', 'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '11560', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '13315', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '05510', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '28033', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '106', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '34335', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': 'RH6 0PA', 'city': 'Gatwick', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.16667, 'lon': -0.18333}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}