- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05299450
Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy (CONCEIVE 2)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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London, Royaume-Uni, W12 0HS
- Imperial College Healthcare NHS Trust
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Exercise intervention
12 week personalised exercise intervention with personal trainer and gym membership, fitbit
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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.
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Expérimental: Beetroot juice
12 weeks daily Beet It (beetroot shots) containing nitrate, fitbit
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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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Expérimental: 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/
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Comparateur actif: Control group
No intervention, fitbit
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Adherence to intervention
Délai: Over 12 week study period
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>/= mean150 minutes/week physical acitvity recorded by Fitbit;
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Over 12 week study period
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Adherence to intervention
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Effect of interventions on physical activity
Délai: 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
Délai: Week 12
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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
Délai: Week 12
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Change in total peripheral resistance in dyn·s/cm5 from from initial visit to final visit at week 12
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Week 12
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Edward WS Mullins, PhD, Imperial College Healthcare NHS Trust
- Chercheur principal: Cristoph C Lees, MD, Imperial College Healthcare NHS Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 274808
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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