Research Protocol April 14

T2D is a major global health issue, characterized by the increasing rate of incidence and a high number of associated complications, which include cardiovascular conditions, neuropathy, nephropathy, and retinopathy (1). In the US for instance, there approximately 34.2 million people living with T2D, with the projections indicating an upward trend in the prevalence of the disease (2). The worsening situation of T2D involves slope of the burden to the morbidity and mortality rates maybe costs in healthcare system (1). The prevalence of T2D in women has increased globally as well. According to a research by Bommer et al. (2018), by 2045, adult women's global T2D prevalence is expected to rise from 9.5% in 2017 to 9.9%. Similarly, the age-standardized prevalence of diabetes in women developed from 4.1% in 1980 to 7.4% in 2014, according to a comprehensive analysis carried out by NCD Risk Factor Collaboration (NCD-RisC) (3). Comment by Rehana Rasul: Is this the correct reference for the incidence rate? Be specific on the actual incidence rate change if you’re specifying trend change Comment by Rehana Rasul: What are the projections- provide the rate change Comment by Rehana Rasul: I don’t understand this wording Comment by Rehana Rasul: What are the mortality rates? What is the incidence? This was not stated above Comment by Rehana Rasul: Is this the correct reference again Comment by Rehana Rasul: Why are you highlighting women? Diabetes is increasing among both men and women. Need rationale Comment by Rehana Rasul: Need Bommer ref here

While there was a significant gender difference in Type 1 and Type 2 diabetes prevalence in England between 2022 and 2023, with more cases reported in the male gender population than in the female population. For instance, statistics from this time period indicated that only 44.4 percent of those diagnosed with Type 2 diabetes were female, compared to 55.6 percent of men. The gender distribution of those registered with diabetes in England in 2022–2023 can be observed in this data (4). Comment by Rehana Rasul: Not sure why this is a new paragraph if your discussion of women started above.

The aetiology of type 2 diabetes is multifactorial, affected by several genetic, lifestyle and environmental mechanisms (1). In addition to these factors, the alternate consuming behavior also has a very significant impact on the formation and the progression of this illness. Many researchers have indicated that some eating habits can result in higher risk of T2D development. In addition, there is a strong association between higher consumption of diets rich in processed foods, sugar-sweetened beverages, and refined carbohydrates and the increased risk of T2D (5, 6). The opposite is true for the dietary pattern in which wholegrain foods, fruits, vegetables, and lean proteins are more consumed; it has been related to the decreased risk of T2D (7, 8). [Mechanisms] Comment by Rehana Rasul: You can reduce these sentences and get right into the statement that T2D can be caused by eating. Unnecessarily verbose Comment by Rehana Rasul: Need refs Comment by Rehana Rasul: These are old refs. Probably a better ref may be meta-analyses of these relationships Comment by Rehana Rasul: Same comment as above. These are old refs and meta-analyses of these should be provided.

The state of New York, characterized by its high population density and diversity, offers an ideal setting for researching the relationship between dietary habits and the incidence of type 2 diabetes in women. The occurrence and treatment of type 2 diabetes in women can be greatly impacted by variables such socioeconomic level, healthcare access, cultural norms, and lifestyle choices (9). Comment by Rehana Rasul: What is the diabetes burden in NY? We are suddenly now shifting to a different pop without any rationale Comment by Rehana Rasul: Why is NY ideal for studying this? Comment by Rehana Rasul: Is your study on women? This is not in your title. Comment by Rehana Rasul: Not sure what the relevance of this sentence is here. You need to build your rationale to your aims in the introduction

Given the rapidly growing incidence of T2D and the substantial part played by dietary patterns in determining risks, there is a need to conduct further studies on the connection between diets and T2D in women. The recognition of the discriminative dietary factors that cause T2D risk can be used to develop strategies for the prevention of the disease and inform public health interventions that focus on reducing the disease burden level. Comment by Rehana Rasul: What’s the gap? How is it connected to NY? NY women? The introduction is not logically ordered to lead to your research question

To investigate the dietary patterns pre valent among women in New York over a 10-year period. Comment by Rehana Rasul: Which dietary patterns? Shilpitha, I already told you to be more specific in the first draft comments and my discussions with you after class. This draft does not address the points I raised. You really need to start over and be more logical or you will end up having the same failing grade as with the first draft. Comment by Rehana Rasul: Please give the time period

· Hypothesis: this study hypothesizes that the dietary patterns of women in New York will show a shift towards higher consumption of processed and high-calorie foods over the 10-year study period.

To analyze the relationship between dietary patterns and the incidence of type 2 diabetes among women in New York. Comment by Rehana Rasul: Which?

· Hypothesis: We hypothesize that specific dietary patterns characterized by high intake of sugary beverages, refined carbohydrates, and saturated fats will be positively correlated with the incidence of type 2 diabetes among women in New York.

To identify potential dietary risk factors associated with the development of type 2 diabetes in this population. Comment by Rehana Rasul: Drop this. It is not an associational aim. We use predictive modeling for this if we don’t have a particular risk factor. This is also very vague.

· Hypothesis: We hypothesize that dietary risk factors such as low intake of fruits, vegetables, and fiber, coupled with high consumption of processed and fried foods, will be associated with an increased risk of developing type 2 diabetes among women in New York

METHODOLOGY OF THE STUDY

Study Design Comment by Rehana Rasul: We already talked about this. This is inconsistent with your aim

This study will apply a retrospective cohort design to assess the role of various dietary patterns in development of type 2 diabetes among women in New York over 10 years. Retrospective cohort studies are developed by identifying subjects who already have a specific disease (type 2 diabetes) and by looking back comparing their exposures (dietary patterns in this case) with those who don't have the disease.

Women living in New York between the ages of 40 and 65 who have been diagnosed with type 2 diabetes and have sought treatment at certain hospital facilities make up the research group. Comment by Rehana Rasul: This doesn’t make sense. How do you determine the outcome if everyone already has the outcome? I thought you were looking at incident T2D?

1. Female gender

2. Age between 40-65 years

3. Already diagnosed with type 2 diabetes

4. Seeking medical care in the government hospitals of New York

Exclusion Criteria:

1. Male gender

2. 40<age>65 years

3. Diagnosed with type 1 Diabetes and comorbidities

The study will start with a comprehensive analysis of medical records that will be gathered from collaboration health facilities wHith a special attention directed towards the cases of middle-aged females that have been diagnosed with type 2 diabetes. These records, which will be examined, contain all the relevant details such as demographic details, medical history, laboratory test results, and any diabetes-related complications that are well documented. Comment by Rehana Rasul: How are you reaching out to the hospitals? What will you then do? The study procedures should be an overview of the actual plan. This soundss more like data collection

The study will start with a comprehensive analysis of medical records that will be gathered from collaboration health facilities with a special attention directed towards the cases of middle-aged females that have been diagnosed with type 2 diabetes. These records, which will be examined, contain all the relevant details such as demographic details, medical history, laboratory test results, and any diabetes-related complications that are well documented. Comment by Rehana Rasul: This is a repeat of the above, but more appropriate in this subheading

As well as medical history review, the study will obtain dietary surveys from participants that capture their dietary patterns over the last decade. These surveys will be deployed for assessment of diet intake through the use of standardized valid instruments that are usually employed for the examination of the frequency of food consumption, the serving sizes, and compliance to specific dietary patterns such as the Mediterranean diet and DASH diet. Comment by Rehana Rasul: References for these dietary patterns? I already told you to pick and define a specific instrument. How will you contact these people to provide this instrument? What about the outcome? How do you determine incident diabetes from the EMR?

Data collection from medical records and dietary surveys will be carried out and later a unified integration process will be utilized to manage the generated information in the centralized data base. The next phase is data integration, which includes standardizing the data format preferred, identifying key variables of interest, and performing quality assurance to ascertain the accuracy and consistency of the dataset. Comment by Rehana Rasul: Redundant Comment by Rehana Rasul: How? Statements too general. Recall how I went over the PCL-5 instrument and explained the scoring system in class, the validity and reliability, … this is not adequate

The sample size for this study will be calculated based on the anticipated incidence rate of type 2 diabetes among women in New York, the assumed effect size wof dietary patterns on diabetes risk, and required statistical power. Previous studies suggested that a diabetes type 2 among this population was 5% of the annual incidence rate (2). When a large effect size is considered, alpha level is kept as 0.05 and power at 80%, a sample size of 500 participants is the minimum to be able to detect associations between dietary patterns and diabetes incidence rate (10). In order to compensate a possible loss of participants and ensure the strength of results, the final sample size may be augmented by a maximum of 20%. Comment by Rehana Rasul: Not necessary. Keep your text to your study Comment by Rehana Rasul: So is this prospective?

Statistical analysis will use both descriptive and inferential statistics methods for testing the dietary patterns on type 2 diabetes rates. The descriptive analysis will present participant characteristics, their food patterns, and diabetes-related outcomes using average, frequency, and percentage figures. Various inferential tests will be used here such as bivariate comparisons using chi-square tests and t-tests, multivariable regression models to check independent associations, and survival analysis techniques to examine time to events relationships (11, 12). Sensitivity analyses (13) will be used to validate the results, and then determine the extent to which any potential biases still prevail. Comment by Rehana Rasul: I already told you about this sentence.

DATA AND SAFETY MONITORING PLAN Comment by Rehana Rasul: I already told you about this.

A data and safety monitoring plan will be used for the study as part of ensuring the research integrity and ethical conduct of human subjects. Regular monitoring will be done to avoid inconsistencies or gaps in data collection process. A data monitoring committee will be set in place to oversee the progress of the study, as well as to review interim analyses and to make sure that adherence to ethical guidelines and regulatory requirements is met (14).

Recall bias, observational design, generalizability to women 40–65 years of age, exclusion of pre-existing chronic medical conditions, and recruitment from healthcare facilities are some of the limitations of this study on dietary patterns and type 2 diabetes in women in New York. Longer follow-up periods may be required for understanding more extensive relationships, and the study's conclusions might not apply to other demographic groups or geographical regions. To strengthen the case for preventative measures and public health initiatives, the study does, however, seek to offer insightful information on how eating habits affect the prevalence of diabetes. Comment by Rehana Rasul: Where does the recall bias come in? What are the issues with the observational design relevant to this study? Are you recruiting? I don’t understand at all how you’re conducting this study. Comment by Rehana Rasul: Not needed.. general

This study will follow ethical guidelines to preserve participants' rights, privacy, and anonymity. The Institutional Review Board or Ethics Committee will provide ethical approval, and participants will provide informed consent. Data will be securely maintained in password-protected electronic databases, anonymised during analysis, and subject to HIPAA laws. The study will follow the ethical principles of beneficence, nonmaleficence, autonomy, and fairness while maximizing participant welfare and reducing damage. The study team will be trained on ethical research practices and human subject protection. This study seeks to contribute responsibly to scientific knowledge and public health development (15). Comment by Rehana Rasul: This whole paragraph is general and doesn’t connect to your study Comment by Rehana Rasul: Not clear if you’re following people with a retrospective design? Comment by Rehana Rasul: Who is the study team? What are their roles?

The results of this study will be getting out in a multi-faceted fashion that will reach not only the stakeholders but also maximize the gravity of the findings. Academic communication is expected to be carried out through the publication of scientific papers in peer-reviewed journals, which will provide extensive information about the study methodology, results, and implications. Scientific conference presentations offer an opportunity for exchange of ideas with the aim of collaborations among researchers, medical professionals, and policymakers now and in the future. Furthermore, digital distribution channels like social media outlets and institutional web pages will be used on the contrary to improve accessibility and reach to a larger population. With an array of dissemination methods, the study findings will be diffused to individuals, communities, and relevant institutions, thus enabling to observe improved public health outcomes. Comment by Rehana Rasul: Most of this is not needed. Just explain your particular study’s dissemination of findings. Be specific to Scientific Conferences and groups interested in this topic.

APPENDIX

1. DAG Comment by Rehana Rasul: You can’t copy someone else’s DAG, especially without reference to them. Directed acyclic graph (DAG) for the causal relationship between... | Download Scientific Diagram (researchgate.net) This DAG doesn’t even make any sense for your proposal. Your exposure is diet pattern, not education, which is what the source was testing. Please use Daggity,net to make your DAG. This is unacceptable and can result in a failing grade.

2. Diet pattern instrument Comment by Rehana Rasul: What instrument is this? Where is the reference?

The following questionnaire is designed to assess the dietary patterns and habits of participants enrolled in the study. Please answer the questions to the best of your ability, providing accurate information about your typical dietary intake over the specified time period.

Section 1: Demographic Information

1. Age:

2. Gender:

3. Ethnicity:

4. Education level:

5. Occupation:

6. Marital status:

Section 2: Dietary Intake

1. How often do you consume fruits and vegetables in a typical week?

· Daily

· 3-4 times per week

· 1-2 times per week

· Rarely

· Never

2. What types of fruits do you commonly consume? (Select all that apply)

· Apples

· Oranges

· Bananas

· Berries (e.g., strawberries, blueberries)

· Grapes

· Other (please specify): ________________

3. What types of vegetables do you commonly consume? (Select all that apply)

· Leafy greens (e.g., spinach, kale, lettuce)

· Cruciferous vegetables (e.g., broccoli, cauliflower, Brussels sprouts)

· Root vegetables (e.g., carrots, potatoes, beets)

· Tomatoes

· Peppers (e.g., bell peppers, chili peppers)

· Other (please specify): ________________

4. How often do you consume whole grains (e.g., brown rice, quinoa, whole wheat bread)?

· Daily

· 3-4 times per week

· 1-2 times per week

· Rarely

· Never

5. What types of protein sources do you commonly consume? (Select all that apply)

· Lean meats (e.g., chicken breast, turkey)

· Fish and seafood

· Legumes (e.g., beans, lentils, chickpeas)

· Nuts and seeds

· Dairy products (e.g., milk, yogurt, cheese)

· Other (please specify): ________________

6. How often do you consume processed or sugary foods and beverages?

· Daily

· 3-4 times per week

· 1-2 times per week

· Rarely

· Never

Section 3: Meal Patterns

1. How many meals do you typically eat per day?

· Three meals per day

· Four meals per day

· Five or more meals per day

· Two meals per day

· One meal per day

2. Do you regularly eat snacks between meals?

· Yes

· No

3. What types of snacks do you commonly consume? (Select all that apply)

· Fruits

· Vegetables

· Nuts and seeds

· Crackers or chips

· Yogurt or cheese

· Other (please specify): ________________

4. How often do you eat out or order takeout each week?

· Daily

· 3-4 times per week

· 1-2 times per week

· Rarely

· Never

Section 4: Beverage Consumption

1. How many cups of water do you drink per day on average?

2. How many cups of coffee or tea do you drink per day on average?

3. Do you consume sugary beverages such as soda, juice, or energy drinks?

· Yes

· No

Section 5: Additional Information

1. Are there any specific dietary restrictions or preferences that you follow? (e.g., vegetarian, gluten-free, lactose intolerant)

2. Have you made any recent changes to your diet or eating habits? If yes, please describe.

3. Do you take any dietary supplements or vitamins regularly? If yes, please specify.

Thank you for completing the questionnaire. Your responses will help us better understand the relationship between dietary patterns and the incidence of Type 2 diabetes among women in New York.

1. American Diabetes Association. (2020). 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2020. Diabetes Care, 43(Supplement 1), S14–S31. Comment by Rehana Rasul: I would expect to see references for your dietary instrument and relationships to diabetes. This reference list is not adequate

2. Centers for Disease Control and Prevention. (2020). National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services.