Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-04 @ 9:51 AM
Study NCT ID:
NCT03468257
Status:
WITHDRAWN
Last Update Posted:
2024-03-08
First Post:
2018-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing a Novel Stress-induced Eating Intervention for Cancer Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study never started', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2018-03-11', 'studyFirstSubmitQcDate': '2018-03-11', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthy Eating Index', 'timeFrame': '14 days after last dose', 'description': 'The Healthy Eating Index was developed by the USDA to capture diet quality. The total score is able to capture both the healthiness of fruits and the unhealthiness of classic comfort foods that are high in calories, fat, and sugar.'}], 'secondaryOutcomes': [{'measure': 'Calorie intake', 'timeFrame': '14 days after last dose', 'description': 'Calorie intake will be recorded across all the foods that the participants choose to eat in the outcome assessment buffet.'}, {'measure': 'Acceptability/Credibility', 'timeFrame': '14 days after last dose', 'description': 'The Credibility/Expectancy Questionnaire is a validated measure to access issues of intervention acceptability, credibility, and expectancy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['7-dose Control - Progressive Muscle Relaxation Only', '5-dose - Pairs Progressive Muscle Relaxation With Fruit 5 Consecutive Days', '7-dose - Pairs Progressive Muscle Relaxation With Fruit 7 Consecutive Days', '9-dose - Pairs Progressive Muscle Relaxation With Fruit 9 Consecutive Days']}, 'descriptionModule': {'briefSummary': 'Subjects will be enrolled in a stress-induced eating intervention with 5, 7, or 9 treatments or control. Treatment will comprise imagining a stressful event, engaging in a stress relief activity (Progressive Muscle Relaxation), and consuming a fruit once per day. There will be one lab visit at baseline in which participants undergo an acute laboratory stressor (i.e., speech and math tasks) and consume food from a buffet. There will be another lab visit at two weeks post-intervention. In the second (and final) lab visit, participants will repeat the acute laboratory stressor (i.e., speech and math tasks) and buffet, and additionally complete questionnaires about their experience in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 or older\n* fluent in English\n* access to an internet-connected device\n* reporting a neutral taste and moderate novelty for at least one fruit\n* reporting household size-adjusted income less than or equal to 200% of the federal poverty threshold\n* perceived stress scale score of 21.82 (1 SD above the national mean)\n* BMI 25\n* scoring 3.23 on the Dutch Eating Behavior-Emotional Eating Questionnaire\n\nExclusion Criteria:\n\n* on a diet that would compel them to refrain from eating food in the laboratory buffet\n* allergy to any foods presented in the buffet\n* selecting a fruit as one or more of top three choices of foods that would make them feel better if stressed'}, 'identificationModule': {'nctId': 'NCT03468257', 'briefTitle': 'Testing a Novel Stress-induced Eating Intervention for Cancer Prevention', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Testing a Novel Stress-induced Eating Intervention for Cancer Prevention', 'orgStudyIdInfo': {'id': '16-000893'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Progressive Muscle Relaxation only', 'description': 'Condition 1: 7-dose control - Progressive Muscle Relaxation only', 'interventionNames': ['Behavioral: Pavlovian Conditioning']}, {'type': 'EXPERIMENTAL', 'label': 'Pairs Progressive Muscle Relaxation with fruit', 'description': 'Condition 2: 5-dose - Pairs Progressive Muscle Relaxation with fruit 5 consecutive days; Condition 3: 7-dose - Pairs Progressive Muscle Relaxation with fruit 7 consecutive days; Condition 4: 9-dose - Pairs Progressive Muscle Relaxation with fruit 9 consecutive days', 'interventionNames': ['Behavioral: Pavlovian Conditioning']}], 'interventions': [{'name': 'Pavlovian Conditioning', 'type': 'BEHAVIORAL', 'description': 'Imagining a stressful event, engaging in progressive muscle relaxation, and eating fruit', 'armGroupLabels': ['Pairs Progressive Muscle Relaxation with fruit', 'Progressive Muscle Relaxation only']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'A. Janet Tomiyama', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}