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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- MSMAIR
- Enrollment
- 302
- Locations
- 2
- Primary Endpoint
- 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.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Pregnant and lactating women Renal patients Age of the individual less than 20 years and more than 75 years.
Outcomes
Primary Outcomes
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.
Time Frame: Baseline, 6 and 12 months
Secondary Outcomes
- 1.We anticipate the correlation between ECG findings & all components of PSQI scores in individuals suffering from cardiometabolic syndrome.(Baseline)
Investigators
Chahat Arora
MSMAIR, MAX-MIME and AcSIR