Faisalabad Initiative of Research and Management of NCDs

Background:

The burden of noncommunicable diseases (NCDs) continues to rise globally, and they have become the leading cause of morbidity and mortality, accounting for over 70% of deaths worldwide¹. Rapid lifestyle transitions and increasing urbanization have disproportionately affected low- and middle-income countries, which now bear a substantial share of the global NCD burden.

Pakistan, with a population of 241.5 million, is experiencing a double burden of both communicable diseases and NCDs¹³. The widespread adoption of sedentary lifestyles and unhealthy dietary patterns has contributed to a marked increase in NCDs across the country².

According to the WHO Hypertension profile 2025, it is the most prevalent NCD in Pakistan, affecting approximately 42% (41% males and 44% females) of the population¹¹, followed by diabetes, with a reported prevalence of 30.8%¹². Additionally, a recent cross-sectional study among adults attending a tertiary care hospital in Islamabad reported dyslipidemia in 71.6% of men and 78.4% of women, indicating a substantial underlying community burden³. Pakistan also ranks tenth among 188 countries in terms of overweight and obesity prevalence, with nearly half of its population classified as overweight or obese⁴. According to World Health Organization data, 58.1% of Pakistanis are overweight, and 43.9% fall within the obese category⁴.

Despite their profound public health and economic implications, efforts to address NCDs remain fragmented and insufficient.17 There remains a significant research gap in community-based NCD screening initiatives, particularly within the suburban and peri-urban communities of Faisalabad creating an unmet need to initiate a preventive strategy at community level to raise awareness about these diseases. This direction will minimize the increasing incidence and prevalence of NCDs and will ensure the quality health outcomes for better future.

Timely identification of these diseases through screening is a critical step in reducing their impact on individuals and societies. Early detection enables cost-effective management, improved patient outcomes and a higher quality of life.14 One of the most important ways of reducing deaths from noncommunicable diseases (NCDs) is to control the risk factors that lead to their development.6 In this context, the present study aims to evaluate a community-based project focusing on disease awareness, screening, and structured referral to trained treating physicians for early diagnosis and management of major NCDs. The findings are expected to inform scalable, evidence-based interventions to reduce NCD burden and improve population health outcomes in Pakistan.

Primary Objective: To determine the prevalence of obesity, diabetes, hypertension, and dyslipidemia (ODHD) in the suburban areas of Faisalabad through community-based health screenings.

Secondary Objective: To establish and pilot a formal referral pathway that connects newly diagnosed and/ or at-risk individuals from suburban Faisalabad to healthcare facility for confirmation of diagnosis and management and treatment adherence through periodic follow-up.

Methodology: This study will be a community-based cohort with a cross-sectional perspective involving creating awareness, screening for (ODHD) with follow-up of participants over a period of three months.

The study will be conducted in selected low-to-middle socioeconomic areas of Faisalabad, Pakistan, located in proximity to Faisalabad Medical Center (FMC).

Faisalabad Medical Center (FMC) will serve as the clinical and research site responsible for diagnostic confirmation, clinical evaluation, treatment initiation, follow-up assessments, and study data management under the supervision of the Principal Investigator.

Participants Eligibility Criteria

Inclusion criteria:

* Age: 18 years and above * Gender: Both male and female * Permanent residents of the selected study areas * Willing to participate and provide informed consent

Exclusion criteria:

* Pregnant and lactating women * Oral and injectable contraceptive users * Individuals with severe physical or cognitive impairments that prevent them from providing informed consent or participating in the screening procedures * Individuals with implanted electronic medical devices (e.g., pacemakers or implantable cardioverter-defibrillators) will not undergo bioelectrical impedance analysis (BIA) for body composition assessment.

Data collection procedures Phase I :Community based screening in the camps (First Contact)

1. Participant recruitment and informed consent: All individuals aged 18 years and older residing within 5-10 kms vicinity of Faisalabad Medical Center (FMC) will be invited to participate in the screening camps. Screening will be performed to identify at risk individuals for obesity, diabetes, hypertension, and dyslipidemia (ODHD). Individuals meeting the predefined screening-positive criteria will be considered eligible for enrollment into the study cohort. Screen-negative individuals will receive counseling and health education but will not be enrolled in the follow-up cohort. Written informed consent will be obtained from all participants before initiation of any screening activity. 2. Baseline data collection

* Interview and screening questionnaire administration: screening camps will be organized to administer a structured questionnaire contains sociodemographic factors (gender, education, marital status), medical and family history of ODHD, physical measurements (blood pressure, anthropometric), and point of care biochemical assessments (random blood glucose, total cholesterol). * Biological samples collected for point-of-care testing and laboratory investigations will be used solely for the purposes described in the protocol. No biological samples will be stored for future research, biobanking, or secondary analyses. Following completion of the required testing, all remaining biological materials will be disposed of in accordance with institutional biosafety procedures.

Infection Prevention, Biosafety, and Quality Control Procedures * All point-of-care blood glucose and cholesterol testing will be performed by trained healthcare personnel in accordance with standard infection prevention and control practices. * Prior to sample collection, participants will undergo hand hygiene where appropriate, and healthcare personnel will perform hand hygiene before and after each participant encounter. * Sterile, single-use lancets will be used for each participant for capillary blood collection and will be discarded immediately after use. Lancets will never be reused between participants. * Healthcare personnel will wear appropriate personal protective equipment (PPE), including disposable gloves, during blood collection and point-of-care testing procedures. Gloves will be changed between participants. * Used lancets and other sharps will be disposed of immediately into puncture-resistant, leak-proof sharps containers located at the screening site. * Contaminated consumables and biomedical waste generated during screening activities will be segregated, handled, transported, and disposed of in accordance with institutional biosafety procedures and applicable biomedical waste management regulations. * Point-of-care testing devices, including glucometers and cholesterol analyzers, will be operated according to manufacturer instructions and will undergo routine maintenance, calibration, and quality control checks to ensure accuracy and reliability of results. * All personnel involved in screening activities will receive training before study initiation on study procedures, informed consent procedures, infection prevention and control measures, biosafety practices, proper use of screening equipment, specimen collection and handling, waste disposal procedures, participant confidentiality, and study documentation requirements. * Screening for Obesity: Anthropometric measurements will include height, weight, waist circumference, and body mass index (BMI). Additionally, a body composition analysis would also be done to measure body fat%. * Screening for Diabetes: Participants will undergo a diabetes risk assessment and those having a score of 4 or greater will further be assessed by measuring random blood glucose (RBG) using a glucometer. * Screening for Hypertension: Blood pressure will be measured using a digital sphygmomanometer, with two readings taken at 1-2-minute intervals and the average recorded. * Screening for Hypercholesterolemia: Biochemical assessments for measuring blood cholesterol will involve point-of-care (POC) testing for cholesterol. 3. Classification of individuals for referral and diagnosis Participants will be classified based on predefined clinical, anthropometric, and biochemical criteria identified during baseline screening. All participants identified based on the below mentioned criteria will be referred to Faisalabad Medical Center (FMC) for further assessment and diagnostic confirmation.

• Obesity referral criteria\[20\]: Body mass index (BMI) ≥ 25 kg/m² will be classified and referred for consultation at Faisalabad Medical Center (FMC).

• Diabetes Risk Assessment and High Blood Glucose referral criteria\[21\]: A diabetes risk score will be calculated for all participants. Individuals with a total risk score of ≥ 4 will undergo capillary blood glucose testing. Participants with a capillary blood glucose level of ≥ 140 mg/dL will be referred to the FMC for confirmation of the diagnosis.

• Severity of Blood Pressure criteria\[29\]: Participants with an average on-site blood pressure reading of ≥ 140/90 mmHg will be provided with non-pharmacological therapy and will be reassessed in 3 months. These participants will be contacted to visit FMC for confirmation of the diagnosis.

• Hypercholesterolemia referral criteria\[23\]: Participants with a point-of-care (POC) cholesterol reading of ≥ 200 mg/dL will be referred to the FMC for confirmation of the diagnosis.

Emergency Safety and Referral Procedures

Participants identified during community screening with critically abnormal findings or acute medical symptoms will receive immediate medical attention and will not be managed through the routine referral pathway. Critically abnormal findings may include, but are not limited to: * Severe hypertension (e.g., systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥120 mmHg), particularly when accompanied by symptoms. * Markedly elevated blood glucose levels associated with symptoms suggestive of hyperglycemia. * Chest pain suggestive of a cardiac event. * Stroke-like symptoms, including sudden weakness, facial drooping, difficulty speaking, or altered consciousness. * Syncope (fainting), severe dizziness, or any other acute medical condition requiring urgent intervention.

Such participants will be immediately assessed by a designated healthcare professional at the screening site. Where clinically indicated, emergency medical services will be contacted and the participant will be referred to the nearest emergency department or appropriate healthcare facility for urgent evaluation and management. Family members or attendants will be informed whenever feasible, and all emergency referrals will be documented in study records.

Phase II: Faisalabad Medical Center (Second Contact) 4. Diagnostic Confirmation

* Participants will provide additional information through a diagnosis confirmation questionnaire, which will include details on employment and working status, profession, smoking habits, alcohol consumption, dietary intake assessed, and physical activity assessed using a standardized physical activity questionnaire. * All at-risk participants will then undergo appropriate laboratory investigations.

HbA1c FBS Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides, VLDL) Renal Function T

• Treatment adherence and Disease Control [Срок оценки: Patients will be followed for three months]