Blood Pressure
Conditions
Keywords
Blood pressure, Pre-conception, Hypertension, Exercise, Beetroot, Wearable
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.
Interventions
DIETARY_SUPPLEMENTBeet 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/
BEHAVIORALExercise
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.
OTHERControl 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.
Sponsors
Imperial College Healthcare NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to intervention | Over 12 week study period | \>/= mean150 minutes/week physical acitvity recorded by Fitbit; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of interventions on physical activity | 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 |
| Effect of interventions on cardiac output | Week 12 | Change in cardiac output in l/min from initial visit to final visit at week 12 |
| Effect of interventions on total peripheral resistance | Week 12 | Change in total peripheral resistance in dyn·s/cm5 from from initial visit to final visit at week 12 |
Countries
United Kingdom
Outcome results
None listed