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:
Imperial College Healthcare NHS Trust
Organization:
Study Overview
Official Title:
Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONCEIVE 2
Brief Summary:
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).
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: