Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-26 @ 2:00 PM
Study NCT ID:
NCT05299450
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2022-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-02', 'releaseDate': '2023-05-23'}], 'estimatedResultsFirstSubmitDate': '2023-05-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-18', 'studyFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to intervention', 'timeFrame': 'Over 12 week study period', 'description': '\\>/= mean150 minutes/week physical acitvity recorded by Fitbit;'}, {'measure': 'Adherence to intervention', 'timeFrame': 'Over 12 week study period', 'description': 'Percent of supplied beetroot shots consumed'}], 'secondaryOutcomes': [{'measure': 'Effect of interventions on physical activity', 'timeFrame': 'Week 12', 'description': 'Change in minutes/week of physical activity recorded by FitBit from minutes/week of physical activity in week 1 to minutes/week of physical activity in week 12'}, {'measure': 'Effect of interventions on cardiac output', 'timeFrame': 'Week 12', 'description': 'Change in cardiac output in l/min from initial visit to final visit at week 12'}, {'measure': 'Effect of interventions on total peripheral resistance', 'timeFrame': 'Week 12', 'description': 'Change in total peripheral resistance in dyn·s/cm5 from from initial visit to final visit at week 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood pressure', 'Pre-conception', 'Hypertension', 'Exercise', 'Beetroot', 'Wearable'], 'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The study proposes to evaluate the feasibility of a preconception intervention comprising two proven interventions for reducing blood pressure; Beetroot juice; a source of dietary nitrate which reduces BP by 8/4mmHg after 4 weeks(6); Personalised resistance and endurance exercise programme (as per CMO recommendations) which reduces BP by \\~10/5mm Hg over 8-12 weeks (7).', 'detailedDescription': 'A feasibility study will be conducted for a randomised, controlled trial of preconception interventions.\n\nThe study will advertise using posters, social media and on departmental emails at Imperial College Healthcare NHS Trust or Imperial College for women aged 18-45 planning a pregnancy at any time in the future.\n\nThe study will randomise women to 1 of 4 arms Arm 1: Exercise intervention for weeks 1-12 Arm 2: Beetroot juice for weeks 1-12 Arm 3. Exercise and Beetroot juice for weeks 1-12 Arm 4: Control group\n\nWomen will be provided with daily Beetroot juice shots (as per study arm), membership to an Everybody Active centre close to their home, personal training sessions to tailor an exercise program to them (2 initial sessions then monthly), a wearable to track their physical activity and a home BP monitor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-45\n* considering pregnancy at some time in the future\n* no health contra-indications to moderate-vigorous exercise\n* employed by ICHT NHS Trust or Imperial College.\n\nExclusion Criteria:\n\n* Currently pregnant\n* planning pregnancy during the study period, or becoming pregnant during the study period.'}, 'identificationModule': {'nctId': 'NCT05299450', 'acronym': 'CONCEIVE 2', 'briefTitle': 'Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College Healthcare NHS Trust'}, 'officialTitle': 'Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy', 'orgStudyIdInfo': {'id': '274808'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise intervention', 'description': '12 week personalised exercise intervention with personal trainer and gym membership, fitbit', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Beetroot juice', 'description': '12 weeks daily Beet It (beetroot shots) containing nitrate, fitbit', 'interventionNames': ['Dietary Supplement: Beet It shots']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise and Beetroot', 'description': '12 week personalised exercise intervention with personal trainer and gym membership and daily Beet It (beetroot shots) containing nitrate, fitbit', 'interventionNames': ['Dietary Supplement: Beet It shots', 'Behavioral: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'No intervention, fitbit', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Beet It shots', 'type': 'DIETARY_SUPPLEMENT', 'description': "In addition to the procedures for the control group, women will be supplied with 84 Beet-It shots which they will be asked to take every morning with breakfast for 12 weeks. Women below 60kg will be advised to take a proportion of the 'shot' in order to comply with European Commission Accepted Daily Intake for nitrate, the active ingredient, of 0-5mg/kg. https://www.beet-it.com/product/beet-it-sport-shot/", 'armGroupLabels': ['Beetroot juice', 'Exercise and Beetroot']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'In addition to the procedures for the control group, women will be supplied with gym membership for 12 weeks, 2 initial personal training sessions to design a personal exercise program followed by monthly personal training sessions.', 'armGroupLabels': ['Exercise and Beetroot', 'Exercise intervention']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Women will be supplied with a wearable device to measure physical activity, weighing scales and a home blood pressure monitor. They will be asked to record minutes of physical activity, exercise undertaken, resting blood pressure, resting heart rate and weight daily for 12 weeks.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Edward WS Mullins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College Healthcare NHS Trust'}, {'name': 'Cristoph C Lees, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College Healthcare NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Available on application to PI, however this was a feasibility study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College Healthcare NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-05-23', 'type': 'RELEASE'}, {'date': '2024-02-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Imperial College Healthcare NHS Trust'}}}}