Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-02-21 @ 11:45 PM
Study NCT ID:
NCT04096404
Status:
UNKNOWN
Last Update Posted:
2019-09-19
First Post:
2019-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015438', 'term': 'Health Behavior'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2019-08-16', 'studyFirstSubmitQcDate': '2019-09-17', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight in kg', 'timeFrame': '3 years', 'description': 'Weight will be measured to the nearest 0.1 kg'}, {'measure': 'Body fat percentage', 'timeFrame': '3 years', 'description': 'Body fat percentage will be measured to the nearest 0.1%'}, {'measure': 'Body mass index in Kg/m2', 'timeFrame': '3 years', 'description': 'calculated from measured height and weight'}], 'secondaryOutcomes': [{'measure': 'Dietary intake', 'timeFrame': '3 years', 'description': 'using a four day food diary collected using a food diary and nutritional analysis app (Libro, 2018)'}, {'measure': 'Physical activity', 'timeFrame': '3 years', 'description': 'using the Epic Physical Activity Questionnaire (EPAQ2) (Wareham et al., 2002)'}, {'measure': 'Participants motivation to eat healthily', 'timeFrame': '3 years', 'description': 'measured using the Healthy Eating Motivation Score (Naughton et al., 2015)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adiposity', 'Behavior, Health']}, 'descriptionModule': {'briefSummary': 'A longitudinal study to determine the effect of gene-based personalised diet and physical activity advice on adiposity indices in university students.', 'detailedDescription': "The study uses a randomised controlled design; data for all variables (participant characteristics, height, weight, body mass index (BMI), waist circumference (WC), body fat percentage (BF%), healthy eating motivation, dietary intake and physical activity) will be collected initially from participants at St Mary's University during September and October 2019. Participants will be genotyped, stratified randomisation (based on genotype and BMI) will be used to allocate participants to three different groups (1. Control: no advice, 2. Non genetic personalised advice: dietary and physical activity advice based on reported dietary intake and physical activity 3. Genotype- based personalised advice: dietary and physical activity advice based on genotype, reported dietary intake and physical activity. Following allocation to groups participants in groups 2 and 3 will receive appropriate dietary and physical activity advice via email (appendix a) and all participants will complete the healthy eating motivation questionnaire for a second time. In April/May 2020 follow up variables (smoking status, weight, BMI, WC, BF%, healthy eating motivation, dietary intake and physical activity) will be measured again. These follow up variables will be measured every September and April/May until September 2022. After each follow up participants in groups 2 and 3 will be resent their dietary and physical activity advice and updated information based on their reported dietary intake and physical activity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Age 18-25 years\n\nExclusion Criteria:\n\n* Pregnancy and lactation\n* Chronic disease\n* A history of disordered eating and following a restricted diet.'}, 'identificationModule': {'nctId': 'NCT04096404', 'briefTitle': 'Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students', 'organization': {'class': 'OTHER', 'fullName': "St Mary's University College"}, 'officialTitle': 'A Longitudinal Study to Determine the Effect of Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students', 'orgStudyIdInfo': {'id': 'SMEC_2018-19_052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'no advice'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non genetic personalised advice', 'description': 'dietary and physical activity advice based on reported dietary intake and physical activity', 'interventionNames': ['Behavioral: Non genetic personalised advice']}, {'type': 'EXPERIMENTAL', 'label': 'Genotype- based personalised advice', 'description': 'dietary and physical activity advice based on genotype, reported dietary intake and physical activity', 'interventionNames': ['Genetic: Genotype- based personalised advice', 'Behavioral: Non genetic personalised advice']}], 'interventions': [{'name': 'Genotype- based personalised advice', 'type': 'GENETIC', 'description': 'Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their genotype via email', 'armGroupLabels': ['Genotype- based personalised advice']}, {'name': 'Non genetic personalised advice', 'type': 'BEHAVIORAL', 'description': 'Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their reported intake, BMI and activity via email', 'armGroupLabels': ['Genotype- based personalised advice', 'Non genetic personalised advice']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St Mary's University College", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}