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.

1. 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)

1. 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 Test (Creatinine, BUN, eGFR, Electrolytes, Albumin) Obesity Diabetes Hypertension Dyslipidemia
• Final diagnosis will be established by physicians at FMC based on a combination of clinical evaluation, laboratory findings, and relevant diagnostic criteria, in accordance with national and international standard guidelines for non-communicable diseases.

1. Management and treatment plan for identified Non- Communicable Diseases All participants diagnosed with non-communicable diseases (NCDs) following confirmatory evaluation at Faisalabad Medical Center (FMC) will be managed in accordance with national and international standard guidelines. General Lifestyle and Non-Pharmacological Management All at-risk individuals and diagnosed participants will receive counseling and guidance on the following lifestyle modification measures as the first-line management strategy:

• Adoption of a healthy and balanced diet, including reduced salt intake, reduced refined sugars, and appropriate fat intake
• Weight management through healthy dietary practices
• Promotion of regular physical activity, as per individual capacity
• Smoking cessation counseling
• Reduction or avoidance of alcohol consumption
• Behavioral counseling to encourage long-term adherence to healthy lifestyle practices These interventions will be reinforced during follow-up visits and referrals. Disease-Specific Management In addition to general lifestyle modifications, disease-specific management will be provided where clinically indicated. Detailed treatment protocols aligned with standard clinical guidelines are provided in the respective annexures.
• Management of Obesity- Annexure I Pharmacological therapy will be considered where clinically indicated, in accordance with American Diabetes Association (ADA) guidelines, alongside nutritional, physical, and behavioral therapies.
• Management of Diabetes - Annexure I Pharmacological therapy will be initiated where clinically indicated, following the American Diabetes Association (ADA) guidelines.
• Management of Hypertension - Annexure II Pharmacological treatment will be initiated where clinically indicated, in accordance with the 4th National Hypertension Guidelines.
• Management of Dyslipidemia Annexure III Statin therapy and other pharmacological interventions will be initiated as per AHA Guidelines on Management of Blood Cholesterol Phase III: Faisalabad Medical Center (Third Contact)

1. Follow-up and Monitoring Participants initiated on treatment will be followed up at 1 month for safety data and at 3-months for evaluating the control of the disease. Follow-up will assess

• Self-reported adherence to prescribed medications and lifestyle advice
• Self-reported occurrence of any adverse effects related to prescribed treatment
• Repeat measurements / Laboratory investigations where required Data Collection Team and Personnel Data collection will be carried out by a trained multidisciplinary field team under the supervision of the principal investigator. The team will comprise around 5 personnel, organized into screening and coordination roles to ensure efficient and standardized implementation of community-based screening activities.

Team Composition and Roles

Field Screening Team:

Community screening activities will be conducted by trained healthcare workers, supported by two field workers (1 male \& 1 Female) and one field manager. The healthcare workers will be responsible for participant registration, informed consent, questionnaire administration, anthropometric measurements, blood pressure assessment, and point-of-care testing for blood glucose and cholesterol. The field workers will assist with community mobilization and on-site logistics.

The field manager will oversee daily screening activities, ensure adherence to study protocols, verify completeness and accuracy of collected data, and ensure timely referral of participants to Faisalabad Medical Center.

Clinical, Research, and Data Management Team:

The study will be conducted by a qualified physician and 2 research associates (1 male, 1 female). The physician will perform clinical evaluations, confirm diagnoses, and initiate treatment according to standard-of-care guidelines. The research associates will ensure participants' consent, questionnaire completion, facilitate physician's consultations, ensure completion of required laboratory investigations, participant follow-up and management, perform data entry and secure storage of study data and complete adverse drug reaction (ADR) forms during follow-up if any participant experiences medication-related side effects.

Data Storage, Confidentiality, and Access Control All paper-based study documents, including consent forms and screening questionnaires, will be stored in locked filing cabinets at Faisalabad Medical Center (FMC) under the supervision of the Principal Investigator. Electronic data will be entered into a password-protected and access-restricted database maintained on secure institutional computers at FMC.

Each participant will be assigned a unique study identification number. Identifiable information will be stored separately from study data in a password-protected linkage file accessible only to the Principal Investigator. All analyses will be conducted using de-identified (coded) datasets.

Access to identifiable data will be strictly limited to the Principal Investigator and designated authorized study personnel. Co-investigators and data analysts will have access only to coded or anonymized data. Incase needed the data will only be shared in encrypted form as permitted by the Principle Investigator. The study sponsor (Getz Pharma (Pvt) Limited) will not have access to identifiable or individual-level coded data and will only receive aggregated, anonymized results for reporting and regulatory purposes.

All study data will be retained securely for five years after study completion in accordance with institutional policies and ethical guidelines. Thereafter, paper records will be securely destroyed, and electronic data will be permanently deleted or stored in encrypted archives as per institutional requirements.

Quality Assurance and Confidentiality Daily review of completed forms will be performed by field manager for screening data and by principal investigator for post-diagnosis and treatment data to identify missing data or inconsistencies in dataset. All personnel will be trained in data confidentiality and participant privacy. Participants will be identified using unique study identification numbers, and access to identifiable data will be restricted to PI and authorized study staff only.

Sampling Methodology and Sampling Frame This study will utilize a community-based, consecutive sampling approach. Two suburban communities of Faisalabad will be purposively selected based on population density, accessibility, and limited access to structured NCD screening services. Within each community, temporary screening camps will be established, supported by a structured awareness and mobilization campaign involving local leaders, community volunteers, and informational outreach to encourage participation.

The sampling frame will include all adults (≥18 years) residing in the selected communities who attend the screening camps during the study period. Participants will be enrolled consecutively until the target sample size is achieved. This approach is appropriate for community health screening initiatives where individuals voluntarily self-present, and it allows efficient recruitment while ensuring broad community coverage. The final sample size of 3,000 participants (including 10% overestimation for attrition) will be distributed across the two communities.

Sample size

Sample size for the study has been calculated as per the prevalence of each disease. Below mentioned formula for sample size calculation is used:

N=(z2 * P * Q)/e2 N= Sample Size Z= Z-Score (1.96) P= Prevalence Q= Non-Prevalence e= Margin of error (5%)

Disease Prevalence % Sample Size Obesity[17] 58% 374 Diabetes[18] 31% 328 Hypertension[24] 43% 374 Dyslipidemia[19] 75% 288 Total sample 1364 (As two areas will be included, the total estimated sample size will be 2,728) Attrition rate 10% of total sample 273 Overall sample ≈ 3000

Statistical Analysis Plan Data will be entered, cleaned, and analyzed using statistical software SPSS v-22. Data will be checked for completeness, consistency, and outliers before performing the analysis. Continuous variables will be assessed for normality using graphical methods (histograms, Q-Q plots) and statistical tests where appropriate.

Descriptive Analysis Descriptive statistics will be used to summarize the study population. Continuous variables will be presented as mean ± standard deviation (SD) for normally distributed data, or median with interquartile range (IQR) for skewed data. Categorical variables will be summarized as frequencies and percentages.

The prevalence of obesity, diabetes, hypertension, and hyperlipidemia will be calculated as proportions with corresponding 95% confidence intervals (CIs). Each condition will be defined according to standard clinical criteria.

Bivariate analyses will be conducted to assess associations between each outcome variable (obesity, diabetes, hypertension, and hyperlipidemia) and independent variables such as age, sex, socioeconomic status, physical activity, dietary habits, smoking status, and family history. The Chi-square test (or Fisher's exact test where appropriate) will be used for associations between categorical variables. Independent sample t-tests or Mann-Whitney U tests will be applied for comparisons involving continuous variables, depending on data distribution.

Multivariable logistic regression analysis will be performed to identify independent factors associated with each outcome. Separate regression models will be constructed for obesity, diabetes, hypertension, and hyperlipidemia. Variables with a p-value <0.20 in bivariate analysis, as well as those considered clinically relevant, will be included in the multivariable models. Adjusted odds ratios (AORs) with 95% confidence intervals will be reported. Model assumptions will be assessed, including multicollinearity using variance inflation factors (VIF).

Missing data will be assessed for extent and pattern. If the proportion of missing data is minimal (<5%), complete case analysis will be performed. For higher levels of missingness, appropriate methods such as multiple imputation may be considered.

All statistical tests will be two-sided, and a p-value of <0.05 will be considered statistically significant.

Follow-up Analysis (3-Month Cohort of at-Risk Individuals) Participants identified as at-risk at baseline will be enrolled in a 3-month follow-up cohort. Laboratory investigations and clinical measurements will be obtained at baseline and at 3 months.

Changes in clinical and laboratory parameters (e.g., blood glucose, blood pressure, lipid profile, BMI) between baseline and 3 months will be assessed using paired t-test for normally distributed variables and Wilcoxon signed-rank test for non-normally distributed variables. Effect of treatment and adherence outcomes will be compared across treatment groups (on treatment vs not on treatment) and adherence categories (good vs poor adherence) using independent t-test or Mann-Whitney U test for two groups and ANOVA or Kruskal-Wallis test for more than two groups as appropriate.

Regression models (e.g., linear regression for continuous outcomes, logistic regression for binary outcomes) will be used to assess predictors of improvement at 3 months, adjusting for baseline values and potential confounders.

Study Outcomes Primary Outcomes

1. Proportion of screened participants identified for:

• Overweight and Obesity
• Diabetes mellitus
• Hypertension
• Dyslipidemia

1. Proportion of participants who convert to standard-of-care treatment following diagnostic confirmation within three months.

Secondary Outcomes

The secondary outcomes of this study include:

1. Treatment adherence

• Proportion of participants with confirmed NCD diagnoses who report adherence to prescribed medications and recommended lifestyle modifications at three-month follow-up.

1. Disease Control o To measure the reduction in ODHD symptoms and laboratory investigations through repeat assessments at follow up.

Ethical Considerations

• This study will be conducted in accordance with the Declaration of Helsinki and all relevant national ethical guidelines.
• Ethical approval will be sought from ERC-AEIRC prior to initiation of the study.
• Permission and administrative authorization from the local administration of the Community of Faisalabad will be obtained to ensure community acceptance, and smooth operational implementation of field activities.
• Written informed consent will be obtained from all eligible participants before any study-related screening, assessment, data collection, or health evaluation is conducted.
• Participation will be entirely voluntary, and participants may withdraw at any time from the study.
• All participants identified with abnormal screening results will be counseled and referred appropriately for further evaluation and management at Faisalabad Medical Center.
• Participants identified with urgent or life-threatening clinical conditions during screening will receive immediate referral to emergency medical services or an appropriate healthcare facility. Participant safety will take precedence over all study procedures.
• Confidentiality of participant information will be strictly maintained. Personal identifiers will be removed from all used for analysis, and data will be stored securely with restricted access to the research team only.
• Any adverse events or issues arising during the study will be reported promptly and addressed according to ethical guidelines.

Conflict of Interest This study is sponsored and funded by Getz Pharma (Pvt) Limited. The project is being implemented by Liver Foundation Trust in collaboration with Faisalabad Medical Center (FMC), which serves as the clinical and research site. The sponsor will provide financial and logistical support for the conduct of the study. The sponsor will have no role in determining participant eligibility, diagnosis, treatment allocation, prescribing practices, clinical decision-making, data collection procedures, statistical analyses, interpretation of study findings, manuscript preparation, or publication decisions. The sponsor will not have access to identifiable participant information and will only receive aggregated and anonymized study reports. The principal investigator and study team declare that they have no personal financial or other conflicts of interest related to the conduct, analysis, interpretation, or reporting of study findings. Any potential conflicts arising during the study will be disclosed and managed in accordance with institutional and ethical committee policies.