Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Adherence to intervention
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Currently pregnant
- •planning pregnancy during the study period, or becoming pregnant during the study period.
研究组 & 干预措施
Exercise intervention
12 week personalised exercise intervention with personal trainer and gym membership, fitbit
干预措施: Exercise (Behavioral)
Beetroot juice
12 weeks daily Beet It (beetroot shots) containing nitrate, fitbit
干预措施: Beet It shots (Dietary Supplement)
Exercise and Beetroot
12 week personalised exercise intervention with personal trainer and gym membership and daily Beet It (beetroot shots) containing nitrate, fitbit
干预措施: Beet It shots (Dietary Supplement)
Exercise and Beetroot
12 week personalised exercise intervention with personal trainer and gym membership and daily Beet It (beetroot shots) containing nitrate, fitbit
干预措施: Exercise (Behavioral)
Control group
No intervention, fitbit
干预措施: Control group (Other)
结局指标
主要结局
Adherence to intervention
时间窗: Over 12 week study period
\>/= mean150 minutes/week physical acitvity recorded by Fitbit;
次要结局
- Effect of interventions on total peripheral resistance(Week 12)
- Effect of interventions on physical activity(Week 12)
- Effect of interventions on cardiac output(Week 12)