Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-21 @ 1:36 AM
Study NCT ID:
NCT02777918
Status:
COMPLETED
Last Update Posted:
2019-07-29
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Changing Habits and Lifestyles in Older Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'k.appleton@bournemouth.ac.uk', 'phone': '+441202965985', 'title': 'Prof. Katherine Appleton', 'organization': 'Bournemouth University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Anticipated, but small sample. Should be treated as a pilot study.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'self-report questionnaire assessing number of unusual experiences of nausea, digestive issues (e.g. constipation or diarrhoea), stomach aches/cramps, hunger, bloating/uncomfortable fullness, thirst, headaches, fatigue/tiredness, restlessness, dizziness, or skin rashes.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': '6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.\n\nRecipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 53, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 47, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Questionnaire self-report', 'notes': 'Any unspecified general physical disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 53, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 47, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Egg Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.\n\nRecipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks'}, {'id': 'OG001', 'title': 'Control', 'description': 'Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '20', 'groupId': 'OG000'}, {'value': '4', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Egg intake at the end of the intervention period, assessed using an adapted Food Frequency Questionnaire (FFQ)', 'unitOfMeasure': 'eggs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.\n\nRecipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks'}, {'id': 'OG001', 'title': 'Control', 'description': 'Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Self-declared adverse events over the intervention period, assessed by questionnaire', 'unitOfMeasure': 'Adverse events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change in Dietary Protein Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.\n\nRecipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks'}, {'id': 'OG001', 'title': 'Control', 'description': 'Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations'}], 'classes': [{'categories': [{'measurements': [{'value': '-3', 'spread': '29', 'groupId': 'OG000'}, {'value': '3', 'spread': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Change in dietary protein intake over the intervention and follow-up period, assessed using an adapted FFQ', 'unitOfMeasure': 'g/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Muscle Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.\n\nRecipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks'}, {'id': 'OG001', 'title': 'Control', 'description': 'Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Muscle function over the intervention and follow-up period, assessed using the Short Physical Performance Battery (Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. (1994) A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 49:M85-M94). Higher scores denote better ability - range - 5.0 to +5.0.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Lean Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.\n\nRecipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks'}, {'id': 'OG001', 'title': 'Control', 'description': 'Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '12.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Lean body mass over the intervention and follow-up period, assessed using bioimpedance', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Egg Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.\n\nRecipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks'}, {'id': 'OG001', 'title': 'Control', 'description': 'Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '22', 'groupId': 'OG000'}, {'value': '1', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Egg intake over the follow-up period, assessed using an adapted FFQ.', 'unitOfMeasure': 'eggs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.\n\nRecipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks'}, {'id': 'OG001', 'title': 'Control', 'description': 'Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Self-declared adverse events over the follow-up period, assessed by questionnaire', 'unitOfMeasure': 'Number of adverse events reported', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': '6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.\n\nRecipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks'}, {'id': 'FG001', 'title': 'Control', 'description': 'Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Medical reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Too busy / stressed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': '6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.\n\nRecipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks'}, {'id': 'BG001', 'title': 'Control', 'description': 'Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70', 'spread': '8', 'groupId': 'BG000'}, {'value': '70', 'spread': '7', 'groupId': 'BG001'}, {'value': '70', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-26', 'size': 440779, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-25T03:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2016-05-17', 'resultsFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2016-05-17', 'lastUpdatePostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-03', 'studyFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Egg Intake', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Egg intake at the end of the intervention period, assessed using an adapted Food Frequency Questionnaire (FFQ)'}, {'measure': 'Adverse Events', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Self-declared adverse events over the intervention period, assessed by questionnaire'}], 'secondaryOutcomes': [{'measure': 'Change in Dietary Protein Intake', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Change in dietary protein intake over the intervention and follow-up period, assessed using an adapted FFQ'}, {'measure': 'Muscle Function', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Muscle function over the intervention and follow-up period, assessed using the Short Physical Performance Battery (Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. (1994) A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 49:M85-M94). Higher scores denote better ability - range - 5.0 to +5.0.'}, {'measure': 'Lean Body Mass', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Lean body mass over the intervention and follow-up period, assessed using bioimpedance'}, {'measure': 'Egg Intake', 'timeFrame': '6 months', 'description': 'Egg intake over the follow-up period, assessed using an adapted FFQ.'}, {'measure': 'Number of Adverse Events Reported', 'timeFrame': '6 months', 'description': 'Self-declared adverse events over the follow-up period, assessed by questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['food intake'], 'conditions': ['Eating Behaviour']}, 'descriptionModule': {'briefSummary': 'This is an intervention study, aiming to increase protein intake, by increasing egg consumption in community dwelling older adults aged 55 years and over, by providing recipes to increase flavour and variety in egg dishes.', 'detailedDescription': 'Individuals will be randomized to either receive the intervention or to a control group, where the intervention group will receive 6 recipes every two weeks for a 12 week period, and at the start, after 12 weeks and after 6 months egg intake, protein intake, body protein status, and various functional measures of muscle function will be assessed in both intervention and control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals can be considered for inclusion if they meet the following inclusion criteria:\n\n* being over 55 years old\n* living in the community\n* being able to give consent\n* not being allergic to eggs\n* not suffering from known renal insufficiency, or having a pacemaker or defibrillator.\n* not suffering from known hypercholesterolaemia, or known familial hypercholesterolaemia.\n* not having undergone chemotherapy or radiotherapy in the last 6 months\n* not suffering from any condition, or receiving medication or treatment that the participants feel affects their eating or sense of flavour.\n* being able to perform the physical performance tests (e.g. walk, sit on a chair)\n* being able to read and understand English'}, 'identificationModule': {'nctId': 'NCT02777918', 'briefTitle': 'Changing Habits and Lifestyles in Older Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Bournemouth University'}, 'officialTitle': 'Changing Habits and Lifestyles in Older Individuals', 'orgStudyIdInfo': {'id': 'BUREC12036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.', 'interventionNames': ['Behavioral: Recipe provision']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations'}], 'interventions': [{'name': 'Recipe provision', 'type': 'BEHAVIORAL', 'description': '6 recipes will be provided every 2 weeks by post for 12 weeks', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Katherine M Appleton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bournemouth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Group data will be made available on publication of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bournemouth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'British Egg Industry Council', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}