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Completed

NCT Number: NCT05299450

Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy

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).

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Key information

Conditions

Blood Pressure Behavior Cardiovascular Diseases Hypertension Motor Activity Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Beet It shots

Dietary 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/

Exercise

Behavioral

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 Group

Other

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.

Primary outcomes

  1. Adherence to intervention

    Time frame: Over 12 week study period

    >/= mean150 minutes/week physical acitvity recorded by Fitbit;

  2. Adherence to intervention

    Time frame: Over 12 week study period

    Percent of supplied beetroot shots consumed

Secondary outcomes

  1. Effect of interventions on physical activity

    Time frame: 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

  2. Effect of interventions on cardiac output

    Time frame: Week 12

    Change in cardiac output in l/min from initial visit to final visit at week 12

  3. Effect of interventions on total peripheral resistance

    Time frame: Week 12

    Change in total peripheral resistance in dyn·s/cm5 from from initial visit to final visit at week 12

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Registry information

Acronym: CONCEIVE 2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2022
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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