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

Imperial College Healthcare NHS Trust

Status: Completed

Conditions: Blood Pressure

Treatments: Other: Control group; Behavioral: Exercise; Dietary Supplement: Beet It shots

Study type: Interventional

Funder types: Other

Identifiers

NCT05299450

274808

Details and patient eligibility

About

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).

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 4 patient groups

Exercise intervention

Experimental group

Description:

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

Treatment:

Behavioral: Exercise

Beetroot juice

Experimental group

Description:

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

Treatment:

Dietary Supplement: Beet It shots

Exercise and Beetroot

Experimental group

Description:

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

Treatment:

Dietary Supplement: Beet It shots

Behavioral: Exercise

Control group

Active Comparator group

Description:

No intervention, fitbit

Treatment:

Other: Control group