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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise intervention | Experimental | 12 week personalised exercise intervention with personal trainer and gym membership, fitbit |
|
| Beetroot juice | Experimental | 12 weeks daily Beet It (beetroot shots) containing nitrate, fitbit |
|
| Exercise and Beetroot | Experimental | 12 week personalised exercise intervention with personal trainer and gym membership and daily Beet It (beetroot shots) containing nitrate, fitbit |
|
| Control group | Active Comparator | No intervention, fitbit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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/ |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Effect of interventions on cardiac output |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward WS Mullins, PhD | Imperial College Healthcare NHS Trust | Principal Investigator |
| Cristoph C Lees, MD | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
Available on application to PI, however this was a feasibility study
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 23, 2023 | |
| Reset | Feb 2, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 23, 2023 | Feb 2, 2024 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| 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. |
|
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 | Change in total peripheral resistance in dyn·s/cm5 from from initial visit to final visit at week 12 | Week 12 |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |