Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy

NCT05299450 | Completed

• 1 other identifier: 274808
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Blood Pressure

Keywords

Blood pressure; Pre-conception; Hypertension; Exercise; Beetroot; Wearable

Outcome Measures

Primary Outcomes (2)

• Adherence to intervention

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

  Over 12 week study period

• Adherence to intervention

  Percent of supplied beetroot shots consumed

  Over 12 week study period

Secondary Outcomes (3)

• Effect of interventions on physical activity

  Week 12

• Effect of interventions on cardiac output

  Week 12

• Effect of interventions on total peripheral resistance

  Week 12

Study Arms (4)

Exercise intervention

EXPERIMENTAL

12 week personalised exercise intervention with personal trainer and gym membership, fitbit

Behavioral: Exercise

Beetroot juice

EXPERIMENTAL

12 weeks daily Beet It (beetroot shots) containing nitrate, fitbit

Dietary Supplement: Beet It shots

Exercise and Beetroot

EXPERIMENTAL

12 week personalised exercise intervention with personal trainer and gym membership and daily Beet It (beetroot shots) containing nitrate, fitbit

Dietary Supplement: Beet It shots; Behavioral: Exercise

Control group

ACTIVE COMPARATOR

No intervention, fitbit

Other: Control group

Interventions

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/

Beetroot juice; Exercise and Beetroot

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.

Exercise and Beetroot; Exercise intervention

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.

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Hypertension; Motor Activity

Interventions

Exercise; Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Edward WS Mullins, PhD

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

• Cristoph C Lees, MD

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 29, 2022
• Study Start: December 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: July 31, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)