Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Other: Control group; Behavioral: Exercise; Dietary Supplement: Beet It shots

• Registration Number: NCT05299450
• Lead Sponsor: Imperial College Healthcare NHS Trust

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.

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-07-31
• Study First Submitted: 2022-02-07
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-18
• Last Update Submitted: 2022-03-18
• Study First Posted: 2022-03-29
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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.

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Exclusion Criteria

• Currently pregnant
• planning pregnancy during the study period, or becoming pregnant during the study period.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	No intervention, fitbit
Exercise intervention	Exercise	12 week personalised exercise intervention with personal trainer and gym membership, fitbit
Beetroot juice	Beet It shots	12 weeks daily Beet It (beetroot shots) containing nitrate, fitbit
Exercise and Beetroot	Exercise	12 week personalised exercise intervention with personal trainer and gym membership and daily Beet It (beetroot shots) containing nitrate, fitbit
Exercise and Beetroot	Beet It shots	12 week personalised exercise intervention with personal trainer and gym membership and daily Beet It (beetroot shots) containing nitrate, fitbit

Primary Outcome Measures

Name	Time	Method
Adherence to intervention	Over 12 week study period	Percent of supplied beetroot shots consumed

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom