Blood PressureCONCEIVE 2NCT05299450
Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy
A study testing Beet It shots and Exercise in people with Blood Pressure, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Beet It shots and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Currently pregnant
- planning pregnancy during the study period, or becoming pregnant during the study period.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
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).
Read the 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.
- Conditions
- Blood Pressure
- Being tested
- Beet It shots, Exercise, Control group
- Keywords
- Blood pressure, Pre-conception, Hypertension, Exercise, Beetroot, Wearable
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beet It shotsDietary supplement
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/
ExerciseBehavioural
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | 12 week personalised exercise intervention with personal trainer and gym membership, fitbit Receives: Behavioral: Exercise |
| Beetroot juice | Experimental | 12 weeks daily Beet It (beetroot shots) containing nitrate, fitbit Receives: Dietary Supplement: Beet It shots |
| Exercise and Beetroot | Experimental | 12 week personalised exercise intervention with personal trainer and gym membership and daily Beet It (beetroot shots) containing nitrate, fitbit Receives: Dietary Supplement: Beet It shots; Behavioral: Exercise |
| Control group | Active comparator | No intervention, fitbit Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to intervention
>/= mean150 minutes/week physical acitvity recorded by Fitbit;
Measured: Over 12 week study period
Adherence to intervention
Percent of supplied beetroot shots consumed
Measured: Over 12 week study period
Secondary outcomes (3)
Effect of interventions on physical activity
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
Measured: Week 12
Effect of interventions on cardiac output
Change in cardiac output in l/min from initial visit to final visit at week 12
Measured: Week 12
Effect of interventions on total peripheral resistance
Change in total peripheral resistance in dyn·s/cm5 from from initial visit to final visit at week 12
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Dec 2020
- Primary completion30 Apr 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward WS Mullins, PhD, Principal investigator, Imperial College Healthcare NHS TrustCristoph C Lees, MD, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299450
- Sponsor's protocol ID
- 274808
- Acronym
- CONCEIVE 2
- Status last verified
- Mar 2022
- First submitted
- 7 Feb 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available on application to PI, however this was a feasibility study
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy
- ClinicalTrials.gov ID
- NCT05299450
- Acronym / sponsor ID
- CONCEIVE 2 / 274808
- Conditions
- Blood Pressure
- Keywords
- Blood pressure, Pre-conception, Hypertension, Exercise, Beetroot, Wearable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: Exercise12 week personalised exercise intervention with personal trainer and gym membership, fitbit |
| Beetroot juice | Experimental | Dietary Supplement: Beet It shots12 weeks daily Beet It (beetroot shots) containing nitrate, fitbit |
| Exercise and Beetroot | Experimental | Dietary Supplement: Beet It shots, Behavioral: Exercise12 week personalised exercise intervention with personal trainer and gym membership and daily Beet It (beetroot shots) containing nitrate, fitbit |
| Control group | Active comparator | Other: Control groupNo intervention, fitbit |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Currently pregnant
- planning pregnancy during the study period, or becoming pregnant during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beet It shotsIn 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/ | Dietary supplement | Beetroot juice, Exercise and Beetroot |
| ExerciseIn 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. | Behavioural | Exercise and Beetroot, Exercise intervention |
| Control groupWomen 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. | Other | Control group |
Primary outcome
Adherence to intervention
Time frame: Over 12 week study period
>/= mean150 minutes/week physical acitvity recorded by Fitbit;
Adherence to intervention
Time frame: Over 12 week study period
Percent of supplied beetroot shots consumed
3 secondary outcomes
Effect of interventions on physical activity
Time frame: Week 12
Effect of interventions on cardiac output
Time frame: Week 12
Effect of interventions on total peripheral resistance
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No. Available on application to PI, however this was a feasibility study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward WS Mullins, PhD principal investigator
Imperial College Healthcare NHS Trust
Cristoph C Lees, MD principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beet It shots and Exercise in people with Blood Pressure, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to intervention (time frame: Over 12 week study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.