| CTRI Number |
CTRI/2025/09/094704 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Diet and Lifestyle Changes to Improve Sleep Quality in People with High ~ Blood Pressure, Cholesterol, Sugar Levels and Body Weight. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chahat Arora |
| Designation |
PhD Scholar |
| Affiliation |
MSMAIR, MAX-MIME and AcSIR |
| Address |
MSMAIR (Max Society of Medical Academic Innovation and Research), 26, Community Centre, Behind PVR Anupam,
Goldy Traders Building,
Saket, New Delhi – 110017,India
South
DELHI
110017
India |
| Phone |
9871842533 |
| Fax |
|
| Email |
Chahat.Arora1@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chahat Arora |
| Designation |
PhD Scholar |
| Affiliation |
MSMAIR, MAX-MIME and AcSIR |
| Address |
MSMAIR (Max Society of Medical Academic Innovation and Research), 26, Community Centre, Behind PVR Anupam,
Goldy Traders Building,
Saket, New Delhi – 110017,India
South
DELHI
110017
India |
| Phone |
9871842533 |
| Fax |
|
| Email |
Chahat.Arora1@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Chahat Arora |
| Designation |
PhD Scholar |
| Affiliation |
MSMAIR, MAX-MIME and AcSIR |
| Address |
MSMAIR (Max Society of Medical Academic Innovation and Research), 26, Community Centre, Behind PVR Anupam,
Goldy Traders Building,
Saket, New Delhi – 110017,India
South
DELHI
110017
India |
| Phone |
9871842533 |
| Fax |
|
| Email |
Chahat.Arora1@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| MSMAIR(Max Society of Medical Academics Innovation and Research), Imperial College London, National Institute of Health and Care Research, Devki Devi Foundation |
|
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Primary Sponsor
|
| Name |
MSMAIR |
| Address |
MSMAIR
26, Community Centre, Behind PVR Anupam,
Goldy Traders Building,
Saket, New Delhi – 110017 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Imperial College London ICL and National Institute of Health and Care Research NIHR |
School of Public Health
Imperial College London
Faculty of Medicine
St Mary’s Campus
Norfolk Place, Paddington
London W2 1PG |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Kumar Chopra |
Devki Devi Foundation, India |
2, Press Enclave Road, Saket, New Delhi-110017
South
DELHI |
9650896800
Vijay.Chopra@maxhealthcare.com |
| Chahat Arora |
MSMAIR (Max Society of Medical Academics Innovation and Research) |
MSMAIR
26, Community Centre, Behind PVR Anupam,
Goldy Traders Building,
Saket, New Delhi – 110017
South
DELHI |
9871842533
chahat.arora1@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee, Devki Devi Foundation, Max Super Speciality Hospital(East Block),Saket, New Delhi-110017 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Participants in this group will be provided general advice on diet and lifestyle, including:
1. Eating healthy, balanced food.
2. Avoiding fast food and sugary drinks.
3. Engaging in regular brisk walking. |
| Intervention |
Intervention Group |
Intervention Group – Dietary, Lifestyle, and Sleep Hygiene
Participants in the intervention group will receive a structured awareness aimed at improving sleep quality and promote healthier Dietary habits. The program will cover three main components: (1) Dietary modification – guidance on a balanced nutrition plan emphasizing whole grains, lean proteins, fruits, vegetables, and low-fat dairy, with avoidance of fried foods and sugary drinks. Minor adjustments may be made based on the financial affordability of food items. (2) Physical activity – promotion of regular movement through daily brisk walking, light-to-moderate exercise, and integration of activity into daily routines (e.g., using stairs instead of lifts, walking children to school, or family walks after dinner). (3) Sleep hygiene practices – maintaining a consistent sleep–wake schedule, reducing screen exposure before bedtime, avoiding caffeine close to bedtime, limiting heavy meals close to bedtime, and creating a quiet, dark, and comfortable sleep environment. The awareness program will be delivered through 11 structured sessions over 12 months: 3 initial face-to-face interactions, 3 additional face-to-face sessions, and 5 telephone follow-ups. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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), 1640–1645. 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. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Renal patients
Age of the individual less than 20 years and more than 75 years
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
Baseline, 6 and 12 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1.We anticipate the correlation between ECG findings & all components of PSQI scores in individuals suffering from cardiometabolic syndrome. |
Baseline |
|
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Target Sample Size
|
Total Sample Size="302"
Sample Size from India="302"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
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