Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-30 @ 3:14 PM
Study NCT ID:
NCT04660851
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2020-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Diet Protein Intake in Middle-aged Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-07', 'studyFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2020-12-07', 'lastUpdatePostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in dietary protein intake from baseline', 'timeFrame': '12 weeks', 'description': 'Assessed changes in dietary protein intake from three 24-hour dietary recalls collected at baseline.'}], 'secondaryOutcomes': [{'measure': 'Changes in muscle mass', 'timeFrame': '12 weeks', 'description': 'Changes in muscle mass from baseline were measured using bioelectrical impedance analysis'}, {'measure': 'Changes in upper body muscle strength', 'timeFrame': '12 weeks', 'description': 'Changes in handgrip strength from baseline were measured using hand dynamometer'}, {'measure': 'Changes in lower body muscle strength and function', 'timeFrame': '12 weeks', 'description': 'Changes in 5-chair stand times from baseline were assessed'}, {'measure': 'Changes in muscle function', 'timeFrame': '12 weeks', 'description': 'Changes in 4 meter gait speed from baseline were assessed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Protein intake, coaching, strength'], 'conditions': ['Dietary Habits']}, 'descriptionModule': {'briefSummary': 'The study sought to examine the effectiveness of nutrition education with and without diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.', 'detailedDescription': 'The study sought to examine the effectiveness of nutrition education alone and with 10 weeks of diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able to understand and respond to questions or instructions in English\n* working telephone\n* willingness to consume protein-containing animal products,\n* willingness to make changes to the diet\n\nExclusion Criteria:\n\n* self-reported information that they have been told by a medical doctor that they have kidney (renal) disease\n* current or past history of a diagnosed eating disorder\n* have an internal cardiac pacemaker/defibrillator or other metal-type implant present\n* vegan dietary practices\n* refusal to make changes to usual dietary protein intake\n* usual dietary protein intake greater than 1.2 g per kg body weight'}, 'identificationModule': {'nctId': 'NCT04660851', 'briefTitle': 'Improving Diet Protein Intake in Middle-aged Women', 'organization': {'class': 'OTHER', 'fullName': 'Florida Atlantic University'}, 'officialTitle': 'Improving Diet Protein Intake in Middle-aged Women', 'orgStudyIdInfo': {'id': '1440147-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coached', 'description': '10 weeks of diet coaching', 'interventionNames': ['Behavioral: Coached']}, {'type': 'NO_INTERVENTION', 'label': 'Not-coached', 'description': 'No coaching provided'}], 'interventions': [{'name': 'Coached', 'type': 'BEHAVIORAL', 'description': '10-weeks of diet coaching weekly by telephone to improve dietary protein intake', 'armGroupLabels': ['Coached']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33431', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Atlantic University', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}], 'overallOfficials': [{'name': 'Sareen S Gropper, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor, College of Nursing, Florida Atlantic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida Atlantic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sareen Gropper, PhD, RDN, LDN', 'investigatorAffiliation': 'Florida Atlantic University'}}}}