Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy

Conditions
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Blood Pressure

Intervention / Treatment
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* Dietary Supplement: Beet It shots
* Behavioral: Exercise
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise intervention<br>12 week personalised exercise intervention with personal trainer and gym membership, fitbit | Behavioral: Exercise<br>* 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.<br>|
| Experimental: Beetroot juice<br>12 weeks daily Beet It (beetroot shots) containing nitrate, fitbit | Dietary Supplement: Beet It shots<br>* 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/<br>|
| Experimental: Exercise and Beetroot<br>12 week personalised exercise intervention with personal trainer and gym membership and daily Beet It (beetroot shots) containing nitrate, fitbit | Dietary Supplement: Beet It shots<br>* 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/<br>Behavioral: Exercise<br>* 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.<br>|
| Active Comparator: Control group<br>No intervention, fitbit | Other: Control group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to intervention | >/= mean150 minutes/week physical acitvity recorded by Fitbit; | Over 12 week study period | 
| Adherence to intervention | Percent of supplied beetroot shots consumed | Over 12 week study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 12 | 
| Effect of interventions on cardiac output | Change in cardiac output in l/min from initial visit to final visit at week 12 | 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 | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Pre-conception, Hypertension, Exercise, Beetroot, Wearable