Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-30 @ 11:03 AM
Study NCT ID:
NCT05733260
Status:
UNKNOWN
Last Update Posted:
2023-03-06
First Post:
2022-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Resistance Training Program for Black Women: Project F.I.R.E.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2022-12-16', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': '12 weeks', 'description': 'Changes in body fat percentage assessed by dual x-ray absorptiometry'}, {'measure': 'Body Composition', 'timeFrame': '24 weeks', 'description': 'Changes in body fat percentage assessed by dual x-ray absorptiometry'}], 'secondaryOutcomes': [{'measure': 'Adherence to resistance training', 'timeFrame': '12 weeks', 'description': 'The number of days resistance training is completed each week.'}, {'measure': 'Adherence to resistance training', 'timeFrame': '24 weeks', 'description': 'The number of days resistance training is completed each week.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study will utilize a randomized control trial design, with participants randomly assigned to a theoretically-based culturally tailored intervention or standard of care group. Baseline (Week 0), 12-week, and 3-month follow-up (Week 24). Body composition and adherence will be tracked throughout the study. The exercise intervention will include a total body resistance training protocol and will take place at local fitness center. Participants will be randomized to either the theoretical-based culturally tailored intervention group or the standard exercise group in which each will be facilitated and supervised by a Black-trained research personnel following culturally tailored recommendations. All participants will attend a 10-week resistance training program twice per week for a total of 20 sessions from Weeks 2-11. Week 1 will be used to familiarize the participants with the resistance training exercises. Those randomized to the culturally tailored intervention group will receive health education, weekly text messages and self-regulatory strategies to overcome barriers to exercise. Participants will return for post testing at weeks 12 and 24.', 'detailedDescription': 'This study will utilize a randomized control trial design, with participants randomly assigned to a theoretically-based culturally tailored intervention or standard of care group. Baseline (Week 0), 12-week, and 3-month follow-up (Week 24). Body composition and adherence will be tracked throughout the study. The exercise intervention will include a total body resistance training protocol and will take place at local fitness center. Participants will be randomized to either the theoretical-based culturally tailored intervention group or the standard exercise group in which each will be facilitated and supervised by a Black-trained research personnel following culturally tailored recommendations. All participants will attend a 10-week resistance training program twice per week for a total of 20 sessions from Weeks 2-11. Week 1 will be used to familiarize the participants with the resistance training exercises. Those randomized to the culturally tailored intervention group will receive health education, weekly text messages and self-regulatory strategies to overcome barriers to exercise. Participants will return for post testing at weeks 12 and 24.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 and 34 years\n* Identify as a black female\n* Not actively participating in some type of exercise on a regular basis (at least three days a week for the past three months)\n* Low risk for medical complications from exercise (as determined by the PAR-Q),\n* Not pregnant or planning to become pregnant throughout the duration of the study\n* Must live, work, or be a student in the city of Auburn, AL\n\nExclusion Criteria:\n\n* women over 35\n* Women who do not identify as black\n* Regular exercisers,\n* Pregnant women\n* Women who do not have residency within Auburn AL'}, 'identificationModule': {'nctId': 'NCT05733260', 'briefTitle': 'A Resistance Training Program for Black Women: Project F.I.R.E.', 'organization': {'class': 'OTHER', 'fullName': 'Auburn University'}, 'officialTitle': 'A Resistance Training Program for Black Women: Project F.I.R.E.', 'orgStudyIdInfo': {'id': '22-492 FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Culturally Tailored', 'description': '10 weeks of resistance training utilizing culturally tailored prompts, feedback and high autonomy approaches.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': '10 weeks of resistance training', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': '10 weeks of resistance training.', 'armGroupLabels': ['Control', 'Culturally Tailored']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Danielle D Wadsworth, Ph.D.', 'role': 'CONTACT', 'email': 'wadswdd@auburn.edu', 'phone': '3348441836'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Auburn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Danielle D Wadsworth', 'investigatorAffiliation': 'Auburn University'}}}}