Investigating the Correlations between Sleep Quality Dietary Factors and the Impact of Dietary and Lifestyle Interventions on Sleep Improvement in Patients with Cardiometabolic Syndrome within the GHRU North India Cohort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- We anticipate that there is a relationship between sleep quality and dietary patterns of individuals with cardiometabolic syndrome. We hypothesize that there is a significant relation between all components of PSQI scores, nutrient intake value, and clinical parameters. This provides an understanding of the relationship between sleep quality and cardiometabolic health.We anticipate that there is the relationship between sleep quality and physical activity in individuals with cardiometabolic syndrome.
研究概览
简要总结
This study aims to investigate the correlations between sleep quality, dietary patterns, and the impact of dietary and lifestyle interventions on improving sleep in individuals diagnosed with cardiometabolic syndrome within the GHRU North India Cohort. Eligible participants aged 20–75 years will be screened based on standard clinical criteria for cardiometabolic syndrome and randomly assigned in a 1:1 ratio to either an intervention or control group using computer-generated randomization in Microsoft Excel. The intervention group will receive structured dietary and lifestyle guidance focusing on nutrient intake, physical activity, and sleep hygiene across 11 interaction points (including face-to-face and telephonic sessions) over 12 months. The control group will receive general health advice. Key parameters, including PSQI (Pittsburgh Sleep Quality Index), 24-hour dietary recall (via DietCal software), clinical biomarkers (lipid profile, fasting glucose, HbA1c, blood pressure, BMI, waist circumference) for baseline, 6 months, and 12 months, and baseline ECG readings (will be assessed at baseline only). The primary outcomes include changes in sleep quality and nutrient intake, while secondary outcomes assess correlations between sleep quality and ECG findings (baseline only). This study addresses an important research gap by exploring holistic, lifestyle-based interventions for improving sleep and cardiometabolic health in a North Indian population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants enrolled in the GHRU North India Cohort (CTRI Registration: (CTRI/2022/02/040650)) will be considered eligible for inclusion.
- •Eligibility is based on the diagnostic criteria for Cardiometabolic Syndrome as defined by Alberti et al.
- •(2009), Circulation, 120(16), 1640–
- •DOI: https://doi.org/10.1161/CIRCULATIONAHA.109.192644.Participants must also demonstrate willingness and ability to provide informed consent, adhere to study procedures, and be available for follow-up assessments over the 12-month study period.
排除标准
- •Pregnant and lactating women Renal patients Age of the individual less than 20 years and more than 75 years.
结局指标
主要结局
We anticipate that there is a relationship between sleep quality and dietary patterns of individuals with cardiometabolic syndrome. We hypothesize that there is a significant relation between all components of PSQI scores, nutrient intake value, and clinical parameters. This provides an understanding of the relationship between sleep quality and cardiometabolic health.We anticipate that there is the relationship between sleep quality and physical activity in individuals with cardiometabolic syndrome.
时间窗: Baseline, 6 and 12 months
次要结局
- 1.We anticipate the correlation between ECG findings & all components of PSQI scores in individuals suffering from cardiometabolic syndrome.(Baseline)
研究者
Chahat Arora
MSMAIR, MAX-MIME and AcSIR