Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy
NCT ID: NCT05299450
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2020-12-01
2021-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exercise intervention
12 week personalised exercise intervention with personal trainer and gym membership, fitbit
Exercise
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.
Beetroot juice
12 weeks daily Beet It (beetroot shots) containing nitrate, fitbit
Beet It shots
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/
Exercise and Beetroot
12 week personalised exercise intervention with personal trainer and gym membership and daily Beet It (beetroot shots) containing nitrate, fitbit
Beet It shots
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/
Exercise
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.
Control group
No intervention, fitbit
Control group
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.
Interventions
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Beet It shots
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/
Exercise
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.
Control group
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* planning pregnancy during the study period, or becoming pregnant during the study period.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Imperial College Healthcare NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Edward WS Mullins, PhD
Role: PRINCIPAL_INVESTIGATOR
Imperial College Healthcare NHS Trust
Cristoph C Lees, MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College Healthcare NHS Trust
Locations
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Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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Other Identifiers
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274808
Identifier Type: -
Identifier Source: org_study_id
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