Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT05001633
Status:
UNKNOWN
Last Update Posted:
2022-05-17
First Post:
2021-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will not know what group they are allocated to until the intervention is delivered.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2-arm parallel group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortisol levels', 'timeFrame': 'up to 4 hours', 'description': 'To characterise the effect of a modified media content upon cortisol secretion in people living with obesity.'}], 'secondaryOutcomes': [{'measure': 'heart rate', 'timeFrame': 'up to 4 hours', 'description': 'To characterise the impact of a modified media content on heart rate'}, {'measure': 'systolic and diastolic blood pressure', 'timeFrame': 'up to 4 hours', 'description': 'To characterise the impact of a modified media content on blood pressure'}, {'measure': 'blood glucose', 'timeFrame': 'up to 4 hours', 'description': 'To characterise the impact of a modified media content on blood glucose'}, {'measure': 'salivary hormones', 'timeFrame': 'up to 4 hours', 'description': 'To characterise the impact of a modified media content on salivary hormones - what hormones will be analysed will depend on the availability of assays and will be decided later on at the end of the study'}, {'measure': 'inflammatory cytokines', 'timeFrame': 'up to 4 hours', 'description': 'To characterise the impact of a modified media content on inflammatory cytokines - what cytokines will be analysed will depend on the availability of assays and will be decided later on at the end of the study'}, {'measure': 'dietary intake', 'timeFrame': 'up to 4 hours', 'description': 'To characterise the impact of a modified media content on dietary intake through the use of an online recalling diary called Intake24'}, {'measure': 'experience', 'timeFrame': 'up to 4 hours', 'description': "To evaluate participants' experience through semi-structure interviews"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'media content'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study will explore the impact of exposure to popular media content on patients living with obesity. Findings from this study will provide new insights that will extend current understanding of exposure to media portrayal. This is a proof of principle pilot study that will evaluate the feasibility of recruitment, randomisation, assessment procedures and implementation of the intervention with the aim to facilitate the planning and the conduct of a full-scale randomised controlled trial.', 'detailedDescription': 'This study will explore the impact of exposure to popular media content on patients living with obesity. Findings from this study will provide new insights that will extend current understanding of exposure to media portrayal. This is a proof of principle pilot study that will evaluate the feasibility of recruitment, randomisation, assessment procedures and implementation of the intervention with the aim to facilitate the planning and the conduct of a full-scale randomised controlled trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Not based on self-representation of gender identity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female adults aged 18-65 years.\n2. Body Mass Index equal or greater than 30 kg/m2.\n3. Weight stable at time of recruitment, defined as less than 5% variation in body weight over the preceding 3 months.\n4. Proficient in written and spoken English.\n5. Able to comply with study protocol.\n6. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Type 1 and type 2 diabetes (in view of altered circulated gut hormone profiles and gustatory function).\n2. Smoking (in view of the fact that smoking affects salivary cortisol).\n3. Diagnosed with uncontrolled severe depression.\n4. Diagnosed with uncontrolled psychiatric disorder.\n5. Previous bariatric surgery.\n6. Acute illness or chronic conditions that may impact HPA including Cushing syndrome.\n7. Known or suspected history of HIV, Hepatitis B or C or other blood-borne diseases (in view of safety regulations regarding exposure to blood products).\n8. Currently using glucocorticoids.\n9. Pregnancy or lactation.\n10. Elevated self-perceived stress as assessed by the Perceived Stress Scale.'}, 'identificationModule': {'nctId': 'NCT05001633', 'briefTitle': 'A Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'A Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity', 'orgStudyIdInfo': {'id': '135462'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'modified media content experience', 'interventionNames': ['Behavioral: modified media content paradigm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'media content experience', 'interventionNames': ['Behavioral: control']}], 'interventions': [{'name': 'modified media content paradigm', 'type': 'BEHAVIORAL', 'description': 'media content', 'armGroupLabels': ['Intervention']}, {'name': 'control', 'type': 'BEHAVIORAL', 'description': 'media content experience', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Adrian C Brown, PhD', 'role': 'CONTACT', 'email': 'a.c.brown@ucl.ac.uk'}, {'name': 'Alisia Carnemolla, PhD', 'role': 'CONTACT', 'email': 'a.carnemolla@ucl.ac.uk'}], 'facility': 'University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Adrian C Brown, PhD', 'role': 'CONTACT', 'email': 'a.c.brown@ucl.ac.uk', 'phone': '02076796308', 'phoneExt': '46308'}, {'name': 'Alisia Carnemolla, PhD', 'role': 'CONTACT', 'email': 'a.carnemolla@ucl.ac.uk', 'phone': '02076796308', 'phoneExt': '46308'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}