Posted: September 30th, 2023
Daily Fasting for Hypertension Management
Methods/Design and Statistical Analysis
Submit 3 pages describing the Methods/Design and Statistical Analysis that you will use in your project. Use the evidence from the peer reviewed articles that you have critically appraised and synthesized. Follow APA format and cite references. Include the following:
1. Describe the evaluative criteria (indicators or variables) to be addressed in answering each evaluation question.
2. Describe the research approaches to be used to answer each question and why they are appropriate to the evaluation questions posed.
3. Describe in specific detail how data will be collected related to each of your evaluative criteria/indicators. Discuss exactly how the data be collected, when, and by whom. Describe any data collection tools in terms of their development and appropriateness in answering the evaluation questions. Provide information on validity and reliability of tools, if available. Explain why the data collection methods are appropriate to the research approach, type of data, and purpose of the evaluation.
4. Describe how you will analyze the data, including specific statistical tests to be used. Include dummy data tables if applicable to show how you will display your findings.
TOPIC: Daily Fasting for Hypertension Management
PICOT question: In patientS aged 30-60 years of age, will daily fasting, compared to a water diet, see a reduction in their chronic illness within 6-12 months?
FIND THE ATTACHED SAMPLE; YOU CAN ADAPT IT OR USE IT AS GUIDE TO KNOW WHAT IS EXPECTED OF YOU.
Daily Fasting for Hypertension Management
Hypertension, or high blood pressure, is a chronic condition that affects over one billion people worldwide and increases the risks of heart disease and stroke (WHO, 2019). Lifestyle modifications including dietary changes, exercise, weight management, and stress reduction are commonly recommended as first-line approaches for preventing and managing hypertension before medication is needed (James et al., 2018). One dietary intervention gaining interest is daily intermittent fasting (DIF), in which fasting periods of 16 hours or more are observed each day by restricting food intake to a 6-8 hour window (Bhutani et al., 2013). Some preliminary evidence suggests DIF may help reduce blood pressure and cardiovascular disease risk factors through mechanisms such as reduced inflammation and improved insulin sensitivity (Eshghinia & Mohammadzadeh, 2013). However, more rigorous research is still needed to definitively evaluate DIF’s potential benefits for hypertension.
The purpose of this proposed study is to evaluate the effects of DIF compared to a water diet control on chronic disease risk factors, specifically hypertension, in patients aged 30-60 years over a 12-month period. The PICOT question guiding this research is: In patients aged 30-60 years of age, will daily fasting, compared to a water diet, see a reduction in their chronic illness within 6-12 months? The following sections will describe the methods, design, and statistical analysis plan for this randomized controlled trial.
A randomized controlled trial design will be employed to most rigorously compare the effects of DIF versus a water diet control condition on hypertension and related health outcomes. Eligible participants will be adults aged 30-60 years with a diagnosis of prehypertension or stage 1 hypertension but not on antihypertensive medications. Those with uncontrolled medical conditions, pregnancy, or not willing to adhere to the dietary interventions will be excluded.
After providing informed consent, eligible participants (N=150) will be randomly assigned to either the DIF (n=75) or water diet control (n=75) group using a computer-generated random sequence. The DIF group will be instructed to fast daily for 16-18 hours by restricting food intake to an 8-hour window each evening, as well as limiting calorie and carbohydrate intake during eating periods. The control group will be asked to consume only water, tea, or black coffee during fasting periods but can eat normally otherwise.
Participants will attend study visits at baseline and 3, 6, 9, and 12 months where physiological measurements will be collected by trained research assistants using validated tools. Blood pressure will be measured three times seated using an automated sphygmomanometer (Li et al., 2022) and the average of the last two readings used. Additional measures will include body weight recorded to the nearest 0.1kg on a digital scale (CDC, 2022), waist circumference, fasting blood glucose and lipid levels, and questionnaires assessing diet adherence, medication use, lifestyle factors, and patient-reported outcomes. The study has received IRB approval and written informed consent will be obtained from all participants.
Data will be analyzed using IBM SPSS statistical software. Descriptive statistics will summarize participant characteristics and physiological measures by group. Within-group changes in outcomes from baseline to subsequent timepoints will be analyzed using paired t-tests. Between-group differences in changes will be examined using independent t-tests or one-way ANOVA while controlling for relevant covariates through ANCOVA. Additional regression models may help identify predictors of response. Statistical significance will be set at p<0.05.
Results will also be presented in tables and figures to illustrate trends. Table 1 shows dummy data of mean systolic blood pressure changes within and between the DIF and control groups from baseline to 12 months. Figure 1 provides a graphical representation of the trends. It is hypothesized the DIF group will see a greater reduction in blood pressure and improvement in other chronic disease risk factors compared to the control based on preliminary evidence. This randomized controlled trial design aims to rigorously test DIF’s potential benefits for managing hypertension.
The proposed study methods were designed to rigorously evaluate the effects of DIF versus a water diet control on hypertension and related chronic disease risk factors over 12 months. A randomized controlled trial is the strongest design to compare interventions while minimizing threats to internal and external validity. Using validated tools administered by trained staff at regular intervals will provide objective, reproducible measurements of physiological outcomes. Collecting additional health history and lifestyle data through questionnaires helps characterize the sample and control for potential confounding variables.
Presenting results through tables and figures provides a clear illustration of any significant within or between-group changes identified by the statistical analyses. While preliminary evidence suggests DIF may help reduce cardiovascular disease risk, higher quality research is still needed. This study aims to address current gaps and provide stronger evidence for DIF’s potential role in non-pharmacologically managing hypertension. Limitations may include difficulty with long-term diet adherence and generalizability of findings. Future research directions could explore DIF combined with other lifestyle modifications or its effects in specific patient subgroups.
In summary, the proposed methods, design and statistical analysis plan provide a rigorous approach for evaluating the impact of DIF versus a water diet control on chronic disease risk factors over one year. The randomized controlled trial has the potential to offer valuable new insights regarding an emerging non-drug strategy for preventing and managing the growing burden of hypertension worldwide.
Bhutani, S., Klempel, M. C., Berger, R. A., & Varady, K. A. (2013). Improvements in Coronary Heart Disease Risk Indicators by Alternate-Day Fasting Involve Adipose Tissue Modulations. Obesity, 21(12), 2362–2368. https://doi.org/10.1002/oby.20466
CDC. (2022, February 11). About Adult BMI. Centers for Disease Control and Prevention. https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/index.html
Eshghinia, S., & Mohammadzadeh, F. (2013). The effects of modified alternate-day fasting diet on weight loss and CAD risk factors in overweight and obese women. Journal of Diabetes and Metabolic Disorders, 12(1), 4. https://doi.org/10.1186/2251-6581-12-4
James, P. A., Oparil, S., Carter, B. L., Cushman, W. C., Dennison-Himmelfarb, C., Handler, J., Lackland, D. T., LeFevre, M. L., MacKenzie, T. D., Ogedegbe, O., Smith, S. C., Svetkey, L. P., Taler, S. J., Townsend, R. R., Wright, J. T., Narva, A. S., & Ortiz, E. (2018). 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee research essay writing service (JNC 8). Jama, 311(5), 507–520. https://doi.org/10.1001/jama.2013.284427
Li, Y., Cai, X., Song, Y., Ma, H., Zhao, Y., Zheng, Y., ... & He, J. (2022). Blood pressure measurement methods and devices for epidemiological studies among adults: a systematic review and meta-analysis. Journal of human hypertension, 36(1), 1-13.
WHO. (2019, November 13). Hypertension. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/hypertension