Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy

Blood Pressure Clinical Trial

— CONCEIVE 2  

Official title:

Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05299450
• Other study ID #: 274808
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2022
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to intervention	>/= mean150 minutes/week physical acitvity recorded by Fitbit;	Over 12 week study period
Primary	Adherence to intervention	Percent of supplied beetroot shots consumed	Over 12 week study period
Secondary	Effect of interventions on physical activity	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
Secondary	Effect of interventions on cardiac output	Change in cardiac output in l/min from initial visit to final visit at week 12	Week 12
Secondary	Effect of interventions on total peripheral resistance	Change in total peripheral resistance in dyn·s/cm5 from from initial visit to final visit at week 12	Week 12