Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy (CONCEIVE 2)

March 18, 2022 updated by: Imperial College Healthcare NHS Trust
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to intervention
Time Frame: Over 12 week study period
>/= mean150 minutes/week physical acitvity recorded by Fitbit;
Over 12 week study period
Adherence to intervention
Time Frame: Over 12 week study period
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
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
Week 12
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
Week 12
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
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College Healthcare NHS Trust

Investigators

  • Principal Investigator: Edward WS Mullins, PhD, Imperial College Healthcare NHS Trust
  • Principal Investigator: Cristoph C Lees, MD, Imperial College Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 274808

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Available on application to PI, however this was a feasibility study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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