Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT06335056
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-28
First Post:
2024-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this 12-week long intervention project, 480 adolescent participants are randomized, at the school level, to 2 arms - ProudMe or waitlist control conditions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Activity self-efficacy', 'timeFrame': '12 weeks', 'description': "An individual-level covariate. Activity self-efficacy refers to adolescents' belief in their capability to participate in physical activity despite barriers. Adolescent participants will complete an 8-item activity self-efficacy measure, to assess activity self-efficacy during free time on most days overall, despite barriers (screen time, weather, location, schedule, social support)."}, {'measure': 'Self-monitoring', 'timeFrame': '3-5 times per week over 12 weeks', 'description': 'An individual-level covariate. Adolescent participants set up daily goals for physical activity, screen time, dietary behaviors, and sleep; track their behavior efforts, and evaluate goal attainment on the ProudMe Tech system.'}, {'measure': 'Social support', 'timeFrame': '12 weeks', 'description': 'An interpersonal-level covariate. To assess the sources and types of social support.'}, {'measure': 'School Wellness Policy', 'timeFrame': '12 weeks', 'description': 'The Wellness School Assessment Tool 3.0 (WellSAT 3.0) to assess environmental/policy changes in schools (pre to post tests).'}, {'measure': 'Cafeteria Nutrition', 'timeFrame': '12 weeks', 'description': 'School Cafeteria Nutrition Assessment (SCNA) to evaluate the lunch menus and observe foods offered in the cafeteria (monthly).'}], 'primaryOutcomes': [{'measure': 'Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers', 'timeFrame': '12 weeks', 'description': 'Self-reported screen time'}, {'measure': 'Screen time', 'timeFrame': '12 weeks', 'description': 'a screen time questionnaire'}, {'measure': 'Food environment', 'timeFrame': '12 weeks', 'description': 'Parent-reported Food Frequency Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Body mass index z score', 'timeFrame': '12 weeks', 'description': "Body mass index (BMI) z scores and BMI scores are converted by weight and height. Body weight is measured to the nearest 0.1kg with a calibrated Seca Model 770 scale. Raw BMI score is calculated from height and body weight as follows: BMI (kg/m2) = Body weight (kg) / Height (m)2. BMI-z score is calculated to examine how many standard deviations adolescents' BMI is above or below the average BMI value for their age group and gender."}, {'measure': 'Waist circumference', 'timeFrame': '12 weeks', 'description': 'Waist circumference at the umbilicus is assessed to the nearest 0.5cm using a constant tension tape.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Treatment (ProudMe)', 'Waitlist Control']}, 'descriptionModule': {'briefSummary': 'This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe. The study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools) and expect to observe improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to the control. The investigators also collect mixed-methods data from 24 school implementers at the 6 ProudMe schools and expect to observe appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost.', 'detailedDescription': 'The Louisiana-based, 12-week, multi-level, multi-component, ecological intervention is called Preventing Obesity Using Digital-assisted Movement and Eating (ProudMe). Guided by robust theories and prior work, this project involves multiple trained student researchers to address two specific aims.\n\nAim 1: to test the effectiveness of the ProudMe intervention in Louisiana middle schools. Informed by power analysis (80% statistical power), the study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools). Quantitative data on obesity-prevention behaviors (i.e., physical activity, screen-based sedentary behavior, diet behaviors) and weight status (i.e., body mass index z score, waist circumference) are collected from all adolescent participants using validated instruments and procedures. The investigators hypothesize the multi-level modeling analyses to show improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to a waist-list control, after controlling for sociodemographic factors at multiple ecological levels.\n\nAim 2: to test the implementation outcomes of the ProudMe intervention in Louisiana middle schools. The investigators collect mixed-methods data from 24 school implementers (i.e., teachers, administrators, and staff), 96 adolescents, and 96 parents at the 6 ProudMe schools, to capture adaptation and implementation indicators. The investigators evaluate the adaptations made across three phases (early, mid, late) of the implementation (i.e., what, at what level, when, how, why, by whom, and impact to intervention). In addition, the investigators assess reach, fidelity, penetration, sustainability, and cost of the implementation across early, mid, and late phases of the implementation. The investigators expect the ProudMe schools to show appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost.\n\nBuilding on previously funded work (e.g., R21HD090513, PI: Dr. Chen), this project is led by a strong, collaborative, transdisciplinary team with experts from kinesiology, developmental psychology, nutrition, childhood obesity, computer science, statistics, and implementation science. The project significantly strengthens the research environment of the Louisiana State University (LSU) - a primarily undergraduate student serving institution under-funded by the NIH. The project creates unique opportunities that are otherwise unavailable for LSU students who aspire to seek advanced education or careers in biomedical and health fields.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'genderBased': True, 'genderDescription': 'All genders are eligible to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students enrolled in 6th, 7th, or 8th grades in participating schools.\n* Students with parental consent and child assent.\n\nExclusion Criteria:\n\n* Students enrolled in grades other than 6th, 7th, or 8th grades\n* Students in non-participating schools.\n* Students without parental consent and child assent.\n* Students without adequate readiness for physical activity.'}, 'identificationModule': {'nctId': 'NCT06335056', 'acronym': 'ProudMe', 'briefTitle': 'Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University and A&M College'}, 'officialTitle': 'Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools', 'orgStudyIdInfo': {'id': 'IRBAM-21-0702'}, 'secondaryIdInfos': [{'id': '1R15HD108765-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R15HD108765-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ProudMe', 'description': 'The ProudMe condition involves three key components: (a) artificial intelligence (AI)-assisted behavior management system (i.e., ProudMe Tech), (b) ProudMe physical/health education (PE) and lunchroom reform (ProudMe Cafeteria), (c) customized implementation training (ProudMe Training).', 'interventionNames': ['Behavioral: ProudMe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist Control', 'description': 'The waitlist control involves (a) regular physical/health education and lunchroom, (b) professional development training on the importance of quality physical/health education, health eating and foot environment. It does not involve AI-assisted behavior management system.', 'interventionNames': ['Behavioral: Waitlist Control']}], 'interventions': [{'name': 'ProudMe', 'type': 'BEHAVIORAL', 'description': 'ProudMe Tech: Regular human/computer interaction (3-5 times per week) to engage in SMART goal-setting, behavior monitoring, and self-reflection as assisted by AI-enabled feedback.\n\nProudMe Physical Education \\[PE\\]: 12 lessons to acquire knowledge, skill, and dispositions to improve physical activity, diet, screen-based sedentary behaviors.\n\nProudMe Cafeteria: Purposely enabling policy and environmental changes in school cafeteria (recognize areas of strengths and weaknesses; set goals and action plans; make changes to improve scores assessed by the Smarter Lunchroom Scorecard).\n\nProudMe Training: 4-hour implementation training + regular check-in and support (via motivational interviewing techniques)', 'armGroupLabels': ['ProudMe']}, {'name': 'Waitlist Control', 'type': 'BEHAVIORAL', 'description': 'The waitlist control involves (a) regular physical/health education and lunchroom, (b) professional development training on the overall importance of quality physical/health education, health eating and foot environment. It does not involve AI-assisted behavior management system.', 'armGroupLabels': ['Waitlist Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70803', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Pedagogical Kinesiology Lab', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louisiana State University and A&M College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, {'name': 'Texas A&M University', 'class': 'OTHER'}, {'name': 'University of Nevada, Las Vegas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}