Participants
Convenience sampling will be used to choose the participants from Willow Point Rehabilitation and Nursing Center in Vestal, NY. Willow Point Rehabilitation and Nursing Center is a nursing home that has a memory care unit and is home to 300 elderly people (Go Broome County, 2017). The residents with at-risk to mild Alzheimer’s disease will be recruited from the nursing home on a voluntary basis. Since, the patients will might not have the proper mind set to consent for themselves, a proxy will be called upon. Patients who attend this clinic are male and females age 65 years and older. The time frame of this study is from 2018-2020 (24-months) and the sample size will be 170 individuals. The questionnaires and examinations will be given during a set time and meeting place, being the nursing home recreational center, and will be repeated every two weeks following the first time point.
Sample Size
According to Go Broome County’s website (2017), Willow Point Rehabilitation and Nursing Center in Vestal, New York has 300 residents. Since 2010, there is an estimated 504 people that live in a nursing facility in Vestal, NY (City-data, 2010). According to the table for recommended sample sizes, the same size based on the population would be 170 people (Krejcie and Morgan, 1970). The 170 individuals will be spilt into half; 85 being those at risk of Alzheimer’s disease and the other 85 individuals being those with mild Alzheimer’s disease.
This study will utilize an experimental design method to determine the effect of the MIND diet’s composition of macronutrients on the progression of Alzheimer’s disease in participants from Willow Point Rehabilitation and Nursing Center compared to the individual’s usual diet’s composition of macronutrients. This study is designed to determine if the MIND diet’s macronutrient composition effects the development of Alzheimer’s disease. The true experimental design will be utilized to estimate the impact of an intervention on the target population with random assignment.
Research Question.
The research question is: Does the MIND diet and the diet’s macronutrient composition slow the progression of Alzheimer’s more than the individual’s regular diet and its macronutrient composition?
Research Hypotheses.
Null Hypothesis: There will be no significant difference between the effects of the MIND diet’s composition of macronutrients and an individual’s usual diet’s composition of macronutrients on the progression of Alzheimer’s disease.
Alternative Hypothesis: The MIND diet’s composition of macronutrients will have a greater effect on slowing the progression of Alzheimer’s disease than the individual’s usual diet’s composition of macronutrients.
Research Variables. The independent variables will be defined as a diet based on the MIND diet and the individual’s usual diet.
Morris et al. (2015) define the MIND diet as:
The MIND diet consists of the consumption of whole grains approximately three servings per day, leafy green vegetables six days per week, other vegetables at least once per day, berries twice per week, red meats less than four times per week, fish once per week, poultry twice per week, beans three times per week, nuts five times per week, and fast/fried food less than once per week. As well as olive oil being used as primary oil, butter, margarine less than one tablespoon per day, pastries, sweets less than five per week, and alcohol/wine once per day. The diet plan will be broken down into the amounts of macronutrients they contain: carbohydrates, protein, and fat (Table 1, p.13).
The individual’s usual diet will be obtained from the individual using a questionnaire and observations. Since the participants are in an assisted living facility, the meals may be set up for the individual. If so, the diet will be recorded from the individual’s direct care worker. The diet will be broken down into the macronutrients: carbohydrates, protein, and fat by using the meal analyzer from Nutrition Workbench App (Nutrition Workbench LLC, 2017).
Research Setting
The study will take place at Willow Point Rehabilitation and Nursing Center in Vestal, New York. This is a community for elders in Broome County that provides specialized rehabilitation services, specialized memory care units, hospice services, and skilled nursing services such as wound care and IV therapy (Go Broome County, 2017).
Procedure
Permission will be obtained from the administrator at Willow Point Rehabilitation and Nursing Center to coordinate a study that will determine the effects of the MIND diet and the individual’s usual diet on the progression of Alzheimer’s disease who reside at the facility. Then permission will need to be acquired from the Institutional Review Board of Mansfield University to start the research. After permission is given, the researcher will invite participants and begin data collection. Permission from the participants will be gained in an ethical manner; if the participants are unable to give consent on their own then a proxy will give consent for said participant.
This study is a true-experiment; the participants will be chosen on a volunteer basis from the nursing home facility. Advertising techniques will be used to gather interest in the study; this includes informational brochures being placed in the communal area at the nursing home as well as receiving recommendations from the nursing home staff (nurses or doctors). Those who are interested would attend a meeting at the nursing home recreation center, where the summary of the study, variety of questionnaires to be completed, the duration, and the obligation of the volunteers will be reviewed. The males and females 65 years and older, that have mild Alzheimer’s disease or whom are at risk of Alzheimer’s disease, that are willing to partake in the experiment will then sign permission forms or if unable to do so have a proxy sign for the individual.
First, each participant will be given a basic questionnaire, which will take about five minutes. The questions will be about the individual’s age, gender, education, lifestyle factors and family history of Alzheimer’s or dementia. The lifestyle factors consist of cognitively exciting activities such as reading and writing, physical activities such as walking and housework, smoking and alcohol consumption. Moreover, the participants will be asked to keep a 24-hour recall diary to assess their current dietary intake. Medical personnel at the nursing home will do the recall in person. A medical doctor or nurse will test the participant’s APOE- genotype by obtaining a blood sample from the participant (Lab Tests Online, 2014). This blood test will determine if the participant has the APOE-e4 allele, if so, that participant has a higher risk of developing Alzheimer’s disease (Dacks, 2016). The participant’s height and weight will be taken and then calculated into the individual’s BMI (Body Mass Index) by a nurse/medical staff. Self-reports of hypertension or hypertensive medication usage will be recorded and blood pressure will be taken. Medical diagnosis of any heart attacks or diabetes history will be determined by the individual’s self-report. Any history of a stroke will be established on the medical professional’s evaluation of self-reported history and cognitive examinations.
Diagnosis of probable and occurring Alzheimer’s disease will be determined at each meeting, which will be every two weeks for two years. Alzheimer’s diagnosis will be made by an experienced medical professional using data from systematized neurological examinations, medical history, cognitive functioning test scores, as well as with support of an algorithmically based ranking of cognitive impairment (Morris et al., 2015). The diagnosis of Alzheimer’s disease will be based on standards of “the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association. The National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association require a history of cognitive decline with memory impairment and at least one other cognitive domain” (McKhann et al., 1984).
Diet scores will be calculated from the results of a quantitative food frequency questionnaire (FFQ) that was used in a study done by Morris, Tangney, Bienias, Evans, & Wilson (2003). The food frequency questionnaire is made up of 144 food items and the participants will be asked to report usual intake based on the food items over the past six months. Energy density and nutritional value for each item will be based on the RDA (recommended dietary allowance). The group of participants following the MIND diet will be scored on the individual’s adherence to the MIND diet based on the food diary. The MIND diet group will keep a food diary that is done with the help of the individual’s direct care worker and the diary will be collected upon meeting every two weeks. The group of participants following their usual diet will keep food diaries with the help of the individual’s direct care worker and the diaries will be collected upon meeting every two weeks. Then the researcher will gather the diaries and calculate the macronutrients by using the Nutrition Workbench App (Nutrition Workbench LLC, 2017) for each individual’s diet both from the participants following the MIND diet and those following their usual diet.
To test the cognitive status of participants adhering to the assigned diets, will be calculated by the Mini-Mental State Examination (MMSE) and Clock Drawing Test (CDT). The Mini-Mental State Examination is a test used to determine the cognitive status of an individual using a score of 30 points being the highest and zero being the lowest. The MMSE should take about 5 to 10 minutes to administer. Examples of questions include: “What is the year? Season? Where are we now?” (Dementia Today, 2012). The Clock Drawing Test is a test to screen people for Alzheimer’s and dementia (Alzheimer’s Association, 2017; Heerema, 2017). For this test, a medical professional asks the participant to fill in the correct number order on a clock. If the test is completed correctly then it indicates that there is no dementia present (score of 1 point). If the test was not completed correctly then it means that further evaluation is necessary (score of 0 points) (Heerema, 2017). The Mini-Mental State Examination and the Clock Drawing Test will be repeated every four weeks during one of the follow-up meetings.
Upon completion of the initial questionnaires and testing, the participant will be assigned randomly into two groups. The MIND diet group will be the experimental group and the usual diet group will be the control group. The first group will be instructed to follow the MIND diet, which will be defined as a diet rich in complex carbohydrates, moderate protein, healthy fats, and low in refined sugars. For the second group, participants will be instructed to consume their everyday diet. Both groups will be provided with a dietitian that can assist them in choosing the proper foods to consume. Participants will have a daily food diary that is produced by their direct care worker medical staff to ensure the correct food and amount will be listed. The food diary will also ensure that the participants are following their prescribed diets.
Every two weeks until the 24-month period is up, all participants will go through the same procedure as at the start of the study. BMI will be calculated, blood pressure will be taken, and blood will be drawn for testing as well as the completion of the cognitive examinations. The results at the end of the two years will be compared between the experimental and control groups.
Statistical Analysis
The analysis of the collected data will be done by using the one way multivariate analysis of variance (MANOVA) (Creswell, p. 166). “This statistical testing measures group differences between more than two independent variables and two or more dependent variables” (Creswell, p.166). Cognitive status, BMI, blood pressure, and APOE-genotype (dependent variables) will be recorded for each participant in both the MIND diet and usual diet (independent variables) groups. Finally, the four factors above will be compared between the MIND and usual diet groups to establish any significant (p<0.05) differences.
Ethical Issues
In order for this research to be ethical approval should be sought through the IRB at Mansfield University. In addition, all participants should receive the same examinations and as volunteers they should not be pressured into signing consent forms. The participants may be incompetent so, a proxy should be called upon for consent. Respect of the site and participants should be maintained. The collected data should be kept for five years after the conclusion of the study (Creswell, p. 90-91).