- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05299450
Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy (CONCEIVE 2)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
A feasibility study will be conducted for a randomised, controlled trial of preconception interventions.
The 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.
The 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
Women 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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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London, Verenigd Koninkrijk, W12 0HS
- Imperial College Healthcare NHS Trust
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Aged 18-45
- considering pregnancy at some time in the future
- no health contra-indications to moderate-vigorous exercise
- employed by ICHT NHS Trust or Imperial College.
Exclusion Criteria:
- Currently pregnant
- planning pregnancy during the study period, or becoming pregnant during the study period.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Exercise intervention
12 week personalised exercise intervention with personal trainer and gym membership, fitbit
|
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.
|
Experimenteel: Beetroot juice
12 weeks daily Beet It (beetroot shots) containing nitrate, fitbit
|
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/
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Experimenteel: Exercise and Beetroot
12 week personalised exercise intervention with personal trainer and gym membership and daily Beet It (beetroot shots) containing nitrate, fitbit
|
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.
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/
|
Actieve vergelijker: Control group
No intervention, fitbit
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Adherence to intervention
Tijdsspanne: Over 12 week study period
|
>/= mean150 minutes/week physical acitvity recorded by Fitbit;
|
Over 12 week study period
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Adherence to intervention
Tijdsspanne: Over 12 week study period
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Percent of supplied beetroot shots consumed
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Over 12 week study period
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Effect of interventions on physical activity
Tijdsspanne: Week 12
|
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
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Week 12
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Effect of interventions on cardiac output
Tijdsspanne: Week 12
|
Change in cardiac output in l/min from initial visit to final visit at week 12
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Week 12
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Effect of interventions on total peripheral resistance
Tijdsspanne: Week 12
|
Change in total peripheral resistance in dyn·s/cm5 from from initial visit to final visit at week 12
|
Week 12
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Edward WS Mullins, PhD, Imperial College Healthcare NHS Trust
- Hoofdonderzoeker: Cristoph C Lees, MD, Imperial College Healthcare NHS Trust
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 274808
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
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