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Running head: HYPERTENSION CONTROL STUDY

Effectiveness of Hypertension Control with Modifiable Lifestyle Changes and Medication

Mary-Margaret Whitten, Kenyatta Wilson, Rebecca Yanci

Old Dominion University

HYPERTENSION CONTROL STUDY 2

Abstract

Aim: To assess whether lifestyle changes alone, are equally as affective as taking

antihypertensive medications to decrease blood pressure.

Background: Hypertension affects 40% of the world’s population, and accounts for 13% of

deaths worldwide. Modifiable risk factors such as unhealthy dietary habits, low levels of

physical activity and excessive alcohol consumption can contribute to the development of

hypertension. If left uncontrolled, hypertension leads to an increased risk of stroke, heart attack,

aneurysm, and kidney disease.

Methods: This study will be a Randomized Control Trail (RCT), using a quantitative

experimental design. The study will include participants ages 18-55, living in the Hampton

Roads area of Virginia. Participants must have received a first time diagnosis of hypertension

during their physical exams, and must not have begun an antihypertensive medication regime.

Participants will be divided into two groups. The results of following the DASH diet and a

moderate exercise program (group 1) will be compared to the results of the group taking

antihypertensive medication, without suggested lifestyle modifications (group 2); in order to

compare their effectiveness in reducing blood pressure readings for each group.

Analysis: The weekly blood pressure results taken by the research team will be recorded in

statistical software, IBM SPSS Statistics. At the conclusion of the study, measures of central

tendency and dispersion will be used to analyze the data. Blood pressure changes associated with

medication use (group 1) and blood pressure changes associated with lifestyle interventions

(group 2) will both reveal a statistical significance level of less than 0.05. When blood pressure

changes from group one are compared to group two, the primary outcome will show that group

two will have decreased their blood pressures as effectively as group one.
HYPERTENSION CONTROL STUDY 3

Limitations: Limitations to this study include the lack of education regarding diet and exercise

for the medication only group (group 1). These participants will follow their own usual diet and

exercise plan, if any, which will vary dramatically. This study was not intended to compare the

effects of various medications against one another. Also, there is a lack of geographic diversity

in the sample. It could be recommended that more researchers be enlisted in various geographic

areas to decrease this limitation. It could also be recommended that studies more narrow in scope

be performed, that are designed to compare lifestyle modifications with specific classes of

medication.
HYPERTENSION CONTROL STUDY 4

Effectiveness of Hypertension Control with Modifiable Lifestyle Changes and Medication

Hypertension (HTN) affects 40% of the world’s population and accounts for 13% of

deaths worldwide (Akinlua, Meakin, Fadahunsi, & Freemantle, 2016). In patients with HTN,

both modifiable and non-modifiable risk factors contribute to the development of the disease.

Modifiable risk factors are those that a patient can change, including living a sedentary lifestyle,

having unhealthy dietary habits, excess consumption of alcohol, and tobacco use. Non-

modifiable risk factors are inherited or unchangeable such as age, race and gender. Uncontrolled

HTN results in an increased force pushing against blood vessel walls, resulting in serious health

complications (Akinlua et al, 2016). Left untreated, HTN increases a patient’s risk of stroke,

heart attack, aneurysm, and kidney disease. It is important to address how HTN can be

controlled to help individuals avoid complications, and premature death from this treatable

disease.

HTN can be treated with both antihypertensive medications and lifestyle changes.

Lifestyle changes affecting modifiable risk factors can reduce a patient’s reliance on medication

therapy, and increase the patient’s overall health status. Over time, studies have determined that

combining lifestyle changes along with medication therapy can reduce both systolic and diastolic

blood pressure reliably (Warren, 2014). More recent studies have suggested that HTN may be

controlled with lifestyle changes alone, and that patients who achieve and maintain control of

their hypertension using lifestyle changes tend to have better long term outcomes, as opposed to

patients who control hypertension with medication alone (Warren, 2014). The purpose of this

study is to use the Integrated Theory of Health Behavior Change (ITHBC), framework to help

determine whether lifestyle changes alone, are equally as affective as taking antihypertensive

medications to decrease blood pressure. It is hypothesized that lifestyle modifications in the form
HYPERTENSION CONTROL STUDY 5

of adherence to the DASH diet and moderate exercise will decrease blood pressure, as

effectively as antihypertensive medication.

Background

Populations Affected by Lifestyle Changes

HTN can affect all ages, from childhood through geriatric patients. The highest rates of

HTN occurs in patients ages 65 and older (Gillespie & Hurvitz, 2013). Currently, the United

States is battling an obesity epidemic, which adversely affects HTN. People consume more

sodium and less potassium in their diets than in the past, and HTN is increasing because of it.

Working to alter modifiable risk factors such as increasing exercise and following a healthy diet,

such as the Dietary Approaches to Stop Hypertension (DASH) diet can contribute to a healthy

lifestyle and control of hypertension (Abdel Hai, Khafagy, & Helmy, 2015).

Without adequate attention, the number of patients with uncontrolled and undiagnosed

hypertension will continue to rise. Additionally, the age at which patients are being diagnosed is

creeping lower, and school age children are commonly receiving hypertension diagnosis. Three

to 12% of children worldwide are currently diagnosed with hypertension (Ramanathan,

Senguttuvan, Prakash, Vengadesan, & Padmaraj, 2016).

Despite the fact that HTN can affect all ages, our study will primarily focus on patients

between the ages of 18 to 55 who are newly diagnosed with the disease. The purpose of these

parameters is to begin a study prior to patients treating the disease, in order to gauge the

effectiveness of lifestyle changes to lower blood pressure compared to antihypertensive

medications.
HYPERTENSION CONTROL STUDY 6

Lifestyle Changes Related to Hypertension Management with Medication

Lifestyle changes affecting modifiable risk factors can reduce a patient’s reliance on

medication therapy, and increase the patient’s overall health status. Over time, studies have

determined that combining lifestyle changes along with medication therapy can reduce both

systolic and diastolic blood pressure reliably (Warren, 2014). More recent studies have suggested

that HTN may be controlled with lifestyle changes alone, and that patients who achieve and

maintain control of their hypertension using lifestyle changes tend to have better long term

outcomes, as opposed to patients who control hypertension with medication alone (Warren,

2014).

Modifiable risk factors such as smoking, excessive alcohol intake, consuming a diet high

in sodium, calories, and fat in combination with living a sedentary lifestyle contribute to the

development of HTN, and can be altered to manage hypertension without medication use

(Warren, 2014). It is important to explore options outside of medication in order to provide

patients with holistic options to manage their health. Because lifestyle changes are free, this is an

important option for those who cannot afford the high cost of commonly prescribed

antihypertensive medication. Incorporating lifestyle changes is also an option for those who

cannot tolerate unpleasant side effects known to certain antihypertensive agents.

Significance

In the United States (US) 36 million Americans suffer from uncontrolled hypertension

despite medical interventions (Laliberte, 2015). The current estimation is one in three adults have

hypertension and approximately one-fifth of these individuals are not aware (Laliberte, 2015).

Hypertension is a major risk factor for heart disease and stroke; which are the first and fourth

leading cause of death in US respectively (Laliberte, 2015). The federal government’s focus for
HYPERTENSION CONTROL STUDY 7

hypertension, according to the Centers for Disease Control (CDC) Healthy People 2020

objective, is “to reduce the prevalence of hypertension among adults to 26.9% (objective HDS-

5.1) and to increase the prevalence of blood pressure control among adults with hypertension to

61.2% (objective HDS-12)” (Gillespie & Hurvitz, 2013). Despite efforts such as the Million

Hearts initiative, launched by Health and Human Services in 2011, no change in the prevalence

of hypertension has changed in the US.

Integrated Theory of Health Behavior Change

The Integrated Theory of Health Behavior Change (ITHBC) is a midrange descriptive

theory developed to facilitate specific changes in health behaviors related to chronic conditions

(Ryan, 2009). The theory is based on research that more than 50% of chronic illnesses are related

to personal behavior and lifestyle (Ryan, 2009). According to ITHBC self-regulation is key to

changing personal behaviors and

persons will be more likely to engage in the recommended health behaviors if they have

information about and embrace health beliefs consistent with behavior, if they develop

self-regulation abilities to change their health behaviors, and if they experience social

facilitation that positively influences and supports them to engage in preventative health

behavior (Ryan, 2009).

This is to say that knowledge alone will not lead to behavior change. In order to effect change, a

patient requires self-regulation and management behaviors which are rooted in both knowledge

and personal health beliefs (Ryan, 2009). For our purposes, patients will be educated on healthier

dietary habits and the importance of engaging in physical activities. Participants will receive

reminder text messages to provide encouragement and social support. Self-regulation and

accountability will be incorporated in the study through the use of tracking logs.
HYPERTENSION CONTROL STUDY 8

Methods

Design

This will be a randomized controlled trail (RCT), using a quantitative experimental

design. Patients who received a first time diagnosis of HTN during their physical exam, and have

not yet started an antihypertensive medication are eligible participants for the study.

Sample

Participants will be selected from Sentara, Riverside, and Mary Immaculate Medical

Center databases in the area of Hampton Roads Virginia; which will include participants from

the following major cities: Hampton, Newport News, Williamsburg, Virginia Beach, Norfolk,

Chesapeake, Portsmouth and Suffolk. Search queries will be performed in the medical centers’

databases to identify patients who received a first time diagnosis of essential HTN, within a

recent two-week timespan. Filters will be added to exclude patients who are pregnant, lactating,

or who have suffered from strokes or heart attacks. Filters will also exclude patients who have

any comorbidity contraindicating participation in moderate exercise or adhering to the DASH

diet.

The inclusion criteria will consist of patients between the ages of 18-55 who have been

diagnosed with HTN. Participants must be able to adhere to the DASH diet, and perform

moderate exercise for at least 30 minutes per day, three times per week (Abdelhai et al, 2015).

Participants must not have begun a pharmaceutical regime to reduce blood pressure, be willing to

accept phone text messages, and literate in English. Demographic factors such as race, gender

and socioeconomic background are not variables the study will intend to control or track.

Rational for design

HYPERTENSION CONTROL STUDY 9

The Hampton Roads area of Virginia has been selected based on its wide demographic

profile, and due to the geographical location of the research team. A two-week first time

diagnosis timeframe (i.e. July15, 2016- July 29, 2016) will be chosen to give researchers the

opportunity to locate participants meeting the above criteria. The chosen time frame also allows

for ample time to select a sample size of at least 50 participants; which is the minimum amount

of participants needed for the study to proceed. The age range of 18-55 maximizes the inclusion

of adult participants, while minimizing the probability that participants may have age induced

hypertension, resulting from a decreased in vascular resistance overtime (American Heart

Association, 2014).

The DASH diet consists of eating foods that are low in cholesterol, total fat, saturated fat,

sodium, and added sugar. Eating more vegetables, fruits, whole grains, poultry, nuts, and fish are

a cornerstone to this dietary approach (Abdelhai et al, 2015). The DASH diet also includes

consuming zero to moderate amounts of alcoholic beverages. Moderate alcohol consumption is

defined as no more than one serving of alcohol per day for females, and no more than two

servings per day for males (Abdelhai et al, 2015). The United States Health and Human Services

Department (USHHSD) recommends following the Dash diet to reduce blood pressure readings.

Cohort, meta-analytical and primary studies have concluded that following the dietary

recommendations of the DASH diet may significantly reduce blood pressure readings in patients

with hypertension (Abdelhai et al, 2015). Previous studies have been conducted combining the

DASH diet in combination with antihypertensive medications. Studies have also been conducted

using the DASH diet within specific parameters such as participants being of a certain race or

social class. These studies show positive results but do not answer the broader question that our

study is designed to answer.

HYPERTENSION CONTROL STUDY 10

Procedures

Two-hundred potential participants from the medical centers’ databases will be contacted

via phone by the Whitten-Wilson-Yanci (WWY) Research Team. The researchers will advise the

patients how their information was obtained and explain the reason for the call. The researchers

will conduct a brief phone survey to screen participants for the study. The survey will consist of

a series of questions that are a mix of open-ended and closed-ended questions (see Appendix A).

The survey is only intended to confirm that the patients meet the inclusion criteria. Participants

will be randomly assigned using probability sampling, such that every subject in the sample has

an equal chance to be chosen for either group (Fain, 2013). The study will be an eight-week trial.

Each participant will attend an initial educational session at the WWY Research Center. The

participants will be educated on the nature of HTN, the effects of HTN and the various treatment

options, according to the National Heart Association Guidelines. During this educational session,

baseline blood pressure readings will be obtained for each participant. Participants will learn to

take accurate blood pressure readings using electronic blood pressure cuffs. Participants in group

one will learn how to complete daily medication and blood pressure logs (see appendix B), and

receive daily text messages reminding them to log and take their medications and blood

pressures. Participants in group one will meet weekly at the WWY Research Center for blood

pressure readings and medication evaluation. Changes to medications may be made based on the

preceding weeks blood pressure logs and patient feedback.

In addition to receiving education about HTN and blood pressure logs, participants in

group two will learn how to incorporate the DASH diet into their lifestyles. Individualized

exercise plans will be established, and education will be provided in regards to completing daily
HYPERTENSION CONTROL STUDY 11

food and exercise logs (see appendix C & D).Participants in group two will also receive daily

text messages related to their diet and exercise regime. These messages will also prompt the

group to complete their daily blood pressure, exercise and food logs. Group two participants will

come to the WWY Research Center once a week for blood pressure readings, and diet and

exercise evaluation. This time will allow the participants to receive personal feedback and extra

education and tips related to maintaining their new lifestyle. Social support will be available as

needed during these meetings to encourage and motivate the participants to continue making

progress.

Instruments

The WWY Research Group creates surveys that are experiment specific. These surveys

are independently verified to meet the criteria for being valid and reliable. All surveys used by

WWY Research Group meet the new instrument standard coefficient alpha score of 0.07 for

reliability. The selected survey has been designed to gather data to confirm that participants meet

the inclusion criteria for this particular study.

Participants will be provided with automatic, cuff-style, bicep monitors that have been

tested, validated and approved by the Association for the Advancement of Medical

Instrumentation, as recommended by the American Heart Association (American Heart

Association, 2014). The participants will receive individual training on how and when to use the

monitors, as well as be given a chance to ask questions regarding the monitors. Participants will

perform reverse demonstrations to display competency.

Tracking logs for blood pressure, dietary intake, physical activity and medication intake

will be provided, and patients will be instructed on when and what to track in their logs.

Tracking instruments that are convenient, user friendly, and appropriate to the participant needs
HYPERTENSION CONTROL STUDY 12

is all that is required. There will be a variety of tracking logs for participants to select from based

on personal preference. Detailed instructions on how to complete the logs will be provided

during the initial meeting, and will be based on the American Heart Association guidelines.

Proposed Analysis

The weekly blood pressure results that were taken by the research team will be recorded

in statistical software, IBM SPSS Statistics. At the conclusion of the study, measures of central

tendency and dispersion will be used to analyze the data. Blood pressure changes associated with

medication use (group 1) and blood pressure changes associated with lifestyle interventions

(group 2) will both reveal a statistical significance level of less than 0.05. When blood pressure

changes from group one are compared to group two, the primary outcome will show that group

two will have decreased their blood pressures as effectively as group one.

Protection of Human Subjects

Prior to beginning the study, informed consent will be obtained from all participants.

Physician approval will also be secured for validating patient participation in the study.

Education regarding hypertensive medications, exercise, and the DASH diet will be explained

thoroughly before informed consent is obtained. Participants must be over the age of 18 and have

the mental capacity to consent.

Risk related to the study include hypotension, or low blood pressure resulting from

prescribed medications. Signs and symptoms include dizziness, decreased urination, thirst, or

nausea (American Heart Association, 2014). The study aims to minimize this risk by requiring

patients to check their blood pressure twice daily, in the morning and evening, as well as

receiving education on the signs and symptoms of hypotension. Participants are instructed to call

their doctor if they experience hypotension and seek immediate medical care if necessary.
HYPERTENSION CONTROL STUDY 13

Institutional Review Board (IRB) approval will be obtained from Old Dominion University, as

the researchers are participants of this university.

Limitations

Limitations to this study include the lack of education regarding diet and exercise for the

medication only group (group 1). These participants will follow their own usual diet and exercise

plan, if any, which will vary dramatically. Additionally, group one members will be prescribed

different antihypertensive medications, with varying classifications of medications. Because of

this, the drugs prescribed may have different mechanisms of action and may react differently in

different patients. This may have a positive or negative affect on blood pressure readings and

may lead to inaccuracy in external validity when comparing effectiveness of antihypertensive

medications across the board. This study was not intended to compare the effects of various

medications against one another. Finally, there is a lack of geographic diversity in the sample.

The limitation to one geographic area, Hampton Roads, Virginia, is due to the inability of

researchers to cover a larger area. It could be recommended that more researchers be enlisted in

various geographic areas to decrease this limitation. It could also be recommended that studies

more narrow in scope be performed, that are designed to compare lifestyle modifications with

specific classes of medication.

HYPERTENSION CONTROL STUDY 14

References

Abdelhi, R., Khafagy, G., & Helmy, H., (2015). DASH diet: How much time does it take to

reduce blood pressure in pre-hypertensive and hypertensive group Egyptian patients?

Middle East Journal of Family Medicine, 13(5), 12-21.

Akinlua, J.T., Meakin, R., Fadahunsi, P., & Freemantle, N. (2016). Beliefs of health care

providers, lay health care providers and lay persons in Nigeria regarding hypertension. A

systematic mixed studies review. Plops One, 11(5), e0154287.

doi:10.1371/journal.pone.0154287

American Heart Association. (2014, August 4). Low blood pressure.

http://www.heart.org/HEARTORG/Conditions/HighBloodPressure/AboutHighBloodPres

sure/Low-Blood-Pressure_UCM_301785_Article.jsp#.V4eL3Y7F6i5

Blumenthal, J.A., Sherwood, A., Smith, P. J., Mabe, S., Watkins, L., Lin, P.H., … Hinderliter, A.

(2015). Lifestyle modification for resistant hypertension: The TRIUMPH randomized

clinical trial. Am Heart J, 170(5), 986-994. doi:10.1016/j.ahj.2015.08.006

Bobrow, K., Farmer, A.J., Springer, D., Shanyined, M., Yu, L.M., Brennan, T., … Levitt, N.

(2016). Mobile phone text messages to support treatment adherence in adults with high

blood pressure (SMS-Text Adherence Support [StAR]): A single-blind, randomized trial.

Circulation, 133(6), 592-600. doi:10.1161/CIRCULATIONAHA.115.017530

Gillespie C. D., Hurvitz, K. A. (2013). Prevalence of hypertension and controlled hypertension –

United States, 2007-2010. MMWR: Morbidity and Mortality Weekly Report, 62, 144-148.
HYPERTENSION CONTROL STUDY 15

Hasandokht, T., Farajzadegan, Z., Siadat, Z.D., Paknahad, Z., & Rajati, F. (2015). Lifestyle

interventions for hypertension treatment among Iranian women in primary health-care

settings: Results of a randomized control trial. Journal of Research in Medical Sciences,

20, 54-61.

Hop, L., & Rittenmeyer, L. (2012). Introduction to evidence-based practice. Philadelphia: F.A.

Davis.

Khatib, R., Schwalm, J.D., Yusuf, S., Haynes, R. B., McKee, M., Kahn, M., & Nieuuwlaat, R.

(2014). Patient and healthcare provider barriers to hypertension awareness, treatment and

follow up: a systematic review and meta-analysis of qualitative and quantitative studies.

PLoS One, 9(1), doi:10.1371/journal.pone.0084238

Laliberte, R. (2015, September 21). Problem Solved! High blood pressure.

http://www.prevention.com/health/high-blood-pressure-remedies

Margolis, K. L., Asche, S. E., Bergdall, A. R., Dehmer, S. P., Maciosek, M. V., Nyboer, R. A.,

…Green, B. B. (2015) A successful multifaceted trial to improve hypertension control in

primary care: Why did it work? J Gen Intern Med, 30(11), 1665-1672.

doi:10.1007/s11606-015-3355-x

Margolius, D., Bodenheimer, T., Bennett, H., Wong, J., Ngo, V., Padilla, G., & Thom, D. H.

(2012). Health coaching to improve hypertension treatment in a low-income, minority

population. Ann Fam Med, 10(3), 199-205. doi:10.1370/afm.1369

Posadzki, P., Cramer, H., Kuzdal, A., Lee, M. S., & Ernst, E. (2014). Yoga for hypertension: a

systematic review of randomized clinical trials. Complement Ther Med, 22(3), 511-522.

doi:10.1016.jctim.2014.03.009
HYPERTENSION CONTROL STUDY 16

Punita, P., Trakroo, M., Rp, S., Subramanian, S., Bhavanani, A., & Madhaven, C. (2015).

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Warren, E. (2014). Hypertension: why we measure it, why we treat it. Practice Nurse, 44(12),

14-19.
HYPERTENSION CONTROL STUDY 17

Appendix A

Phone Survey Questions:

1. Since the time of diagnosis, have you been treated with any antihypertensive medications?

2. Are you between the ages of 18 and 55? If so, please state your age.

3. Would you be willing to exercise at least 30 min a day, three times a week?

4. Do you drink alcohol?

5. If yes, on average, how many drinks do you have per week?

6. Would you be willing to be on a special diet for the time of this study?

7. What is your main spoken language?

8. Will you be able to receive/send text messages throughout this study?

9. Will you be able to get transportation to/from our research center for weekly blood pressure

readings?
HYPERTENSION CONTROL STUDY 18

Appendix B
HYPERTENSION CONTROL STUDY 19

Appendix C

http://what-is-the-dash-diet-plan.blogspot.com/2015/04/dash-diet-meal-planner.html#.V4e-QMLmrvY
HYPERTENSION CONTROL STUDY 20

(AHA, 2014)
HYPERTENSION CONTROL STUDY 21

Appendix D

. https://laminating.blackanddecker.com/home/food-and-health/exercise-logs/exercise-log-back-to-basics.html
HYPERTENSION CONTROL STUDY 22

Honor Code

“I pledge to support the Honor System of Old Dominion University. I will refrain from

any form of academic dishonesty or deception, such as cheating or plagiarism. I am aware that as

a member of the academic community it is responsibility to turn in all suspected violators of the

Honor Code. I will report to a hearing if summoned.”

Name: Mary-Margaret Whitten, Kenyatta Wilson, Rebecca Yanci

Signature: Mary-Margaret Whitten, Kenyatta Wilson, Rebecca Yanci

Date: ___________07/15/2016__________________________