NCT05299450

Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Imperial College Healthcare NHS Trust · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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/
BEHAVIORAL	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.
OTHER	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.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-04-30
• Completion: 2021-07-31
• First posted: 2022-03-29
• Last updated: 2022-03-29

Locations

1 site across 1 country: United Kingdom