Effect of a structured behavioural intervention targeting dietary salt intake modification among individuals with hypertension, in primary care settings in Nagpur: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Primary outcomes will be the changes in mean dietary intake of salt( salt intake in gram/day ).
研究概览
简要总结
This is a randomised controlled trial to evaluate the effectiveness of a structured behavioural counselling intervention for reducing dietary salt intake among adults with hypertension attending primary health centres in Nagpur, India. The study will include sixteen clusters, with eight clusters assigned to the intervention arm and eight clusters to the control arm. Participants in the intervention arm will receive group counselling sessions, educational materials, and regular reminders to reduce salt consumption, while the control arm will receive routine care. The primary outcome is the change in mean dietary salt intake measured by 24-hour urinary sodium. Secondary outcomes include change in blood pressure and the proportion of participants classified as salt sensitive. The intervention will be implemented over three months, with outcome measurements taken at baseline and three months post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •The diagnosed hypertensive individuals of age group 18 years and above, receiving regular follow-up for more than 3 months, who are willing to participate in the study.
排除标准
- •Bedridden patients, patients with CKD, or any other conditions where a salt-reduction diet is prescribed.
- •Families not providing consent to participate in the study will also be excluded.
结局指标
主要结局
Primary outcomes will be the changes in mean dietary intake of salt( salt intake in gram/day ).
时间窗: Baseline and 3 months post intervention
次要结局
- 1) Changes in Systolic Blood Pressure and Diastolic Blood Pressure (SBP and DBP) in mm/Hg per reduced salt in gram/day.(2)Proportion of participants classified as salt-sensitive, stratified by sex (Salt-sensitive defined as a reduction of five millimetres of mercury or more in systolic or diastolic blood pressure together with a reduction of twenty millimoles per day or more in urinary sodium.))