EVIDENCE BASED PROJECT PROPOSAL 2

Keywords: Diet, calorie reduced diet, low carbohydrate diet, moderate carbohydrate diet, exercise, aerobics, moderate physical activity, Type 2 Diabetes, HbA1c, A1c, HbA1c, resistance training, vegetarian, vegan, Mediterranean.

Introduction: Evidence-Based Project Proposal

This proposed project seeks to discover if adults with Type 2 Diabetes Mellitus (T2DM) blood glucose levels are best controlled with a moderate exercise program alone, or if diet paired with exercise has the most significant impact on HbA1c levels. The focus will be on adults, ages 18 and over. T2DM is the most common type of diabetes. In 2017, it was estimated that 425 million adults in the United States had diabetes (Levy, 2019). The projected increase in those with T2DB over the next twenty-five years is a staggering 629 million. This number represents a forty-eight percent increase. The death toll of T2DM-related incidents across the world in 2017 was over four million adults, with a cost of nearly 730 billion dollars for managing the disease (Levy, 2019). There is a need to direct more funding to decrease health disparities to aid in managing chronic diseases such as T2DM (Meit & Knudson, 2017). Implementing research on best practices to manage T2DM, particularly in underserved communities, will result in better health outcomes and decreased disease management costs.

Overview of the Problem: Type 2 Diabetes Management

Diabetes results when insulin production is decreased, or receptor sites fail to function correctly. T2DM makes up ninety-five percent of individuals diagnosed with diabetes and is a disease related to poor diet and overweight or obesity (Levy, 2019). This disease can affect any age group. Just like Type1 diabetes, T2DM is a chronic disease. However, T2DM can be controlled with diet and behavior modification and does not always require pharmacotherapy (Levy, 2019).

HbA1c is a non-fasting blood glucose test that gives a snapshot of blood glucose of the past 90 to 120 days. The test is an accurate measure of control of HbA1c (Levy, 2019). The use of the HbA1c test is an appropriate measure for monitoring those diagnosed with T2DM. Managing chronic illnesses such as T2DM is supported by community healthcare workers and providers of community care. HbA1c levels may be better managed with community healthcare providers who help oversee the management of the disease process. Education and follow up are key to controlling the disease process (Levy, 2019).

Community health nurses can play an active role in the management of T2DM via education and accountability (Crespo, Christiansen, Tieman & Wittberg, 2020). Diet and exercise play a significant role in the management of blood glucose levels. This paper will explore the best outcomes comparing exercise alone to a diet and exercise regime. In rural communities, there are increased smoking incidents, poor diet, obesity, and diabetes, making diabetes management even more critical. Addressing the needs of those in rural and urban communities and increasing access to medical care can be improved by using online healthcare as a community outreach (Goh, Gao & Agarwal, 2016). The use of online community outreach can reinforce teaching and behavior modification (Goh et al., 2016). Evaluating how exercise and exercise coupled with diet impacts HbA1c levels can improve health outcomes, increase the quality of life, and reduce costs related to unmanaged T2DM.

As the number of individuals living with T2DM increases, more studies are being conducted. T2DM sometimes requires management with medication. The ability to control some factors of T2DM makes it worth researching how this disease process can be best managed for individuals who may not have adequate access to medical care or fully understand the disease process and management.

Project Purpose: Controlling Type 2 Diabetes with Diet and Exercise

This project aims to proposed an intervention based on the review of literature regarding the management of Type 2 Diabetes (T2DM) using exercise alone and comparing that to the outcome of using a combination of training and a controlled diet. By searching evidence-based research and practice, better results for those living with T2DM can be achieved. This paper will seek to review the literature on the use of various types of diets and intensity and duration of exercise for best outcomes.

Background and Significance: Type 2 Diabetes Management

T2DM is considered a common disease, seen globally in the first world. It is a common disease that has both reversible and irreversible risk factors. Immutable factors that contribute to T2DM are age, genetics, race, and ethnicity. Reversible factors contributing to T2DM include smoking, diet, and physical activity level (Levi, 2019). Studies have revealed that diet and lifestyle are rapidly increasing the incidence in countries that are developing (Sami, Ansari, Butt & Hamid, 2017). It is reported that greater than fifty percent of those living with T2DM die of cardiovascular disease, evidencing the impact elevated blood sugar has on internal organs (Sami et al., 2019). A large number of studies have shown a correlation between inactivity and T2DM. Being active creates a sensitivity to insulin, helping to control blood sugar. Additionally, exercise reduces abdominal fat associated with T2DM (Sami et al., 2018).

As T2DM is slated to increase in overwhelming numbers, and most cases are related to lifestyle, this project comes at a significant time. It is more likely that there are a considerable number of people working from home, sheltering at home, and being inactive than has ever experienced before. The onset of COVID-19 has thrown society into an idle state without a conscious commitment to fight the lifestyle being lived. Physical inactivity and sedentary lifestyles have already been a pandemic of their own, wreaking havoc on health and increasing cases of T2DM. With the addition of a global pandemic and the effects of being sent inside, the sedentary lifestyle has worsened. It has been hypothesized that sheltering at home as a result of COVID-19, the impact of a physically sedentary lifestyle could further negatively impact health outcomes for several years to come (Hall, Laddu, Phillips, Lavie & Arena, 2020). As the effects of a sedentary lifestyle negatively impact those who are otherwise healthy, individuals with T2DM suffer a more significant impact when activity is reduced, making research surrounding combatting T2DM even more significant.

This innovative proposed research project seeks to discover how physical activity alone compares to physical activity combined with diet helps control T2DM. In this proposed project, a group of individuals with T2DM will be randomly selected into three intervention groups. Group one will enter: an exercise program of aerobic walking or other similar exercises for 45 minutes per day, three days per week with caloric restriction and no emphasis on the type of foods consumed. Group two will enter a program of aerobic walking or other similar exercises for 45 minutes per day, 3 days per week and will be placed on a carbohydrate-controlled diet with calorie restriction. Group three will enter a program of aerobic walking or other similar exercises for 45 minutes per day, three days per week and will be placed on a vegan/vegetarian with no animal products other than non-fat and low-fat dairy and calorie restriction. The result will be recorded over 16 weeks and the outcome data will compare the HbA1C levels between the three groups. The outcomes may be able to help direct providers in providing the best approach to managing T2DM.

The potential impact on individuals with T2DM is assumed to increase healthy outcomes and improve quality of life. The combination of diet and exercise is expected to result in the most exceptional outcomes. As exercise intensity increases, HbA1c levels drop more (Kirwan, Sacks & Nieuwoudt, 2017). The combination of a target heart rate during exercise may prove substantial for many individuals with T2DM and offer greater blood sugar control. The addition of different diet types could prove to be very beneficial at controlling HbA1c levels and finding what diet works best for each individual.

PICOT Formatted Clinical Project Question

The subject for Research from United States University Approved List is [Walking 3x/week or Other exercise activity] for 45-minutes Reduce Blood Sugar levels in [African- Americans or population] with Type 2 Diabetes.

The PICOT Question for Evidence-Based Project Proposal is: In adults with Type 2 Diabetes (P), how do moderate physical activity at least three times per week (I) compare to a modified diet and moderate physical activity at least three times per week (C) affect HbA1c levels (O) after 16 weeks (T)?

Literature Review and Summaries

Key terms used in this search were "diet", "calories reduced diet", "low carbohydrate diet", "moderate carbohydrate diet", "exercise", "aerobics", "moderate physical activity", "Type 2 Diabetes", "HbA1c", "A1c", "controlling HbA1c", "lowering HbA1c", "diet and HbA1c levels", "exercise and HbA1c levels", "social determinants of health", and "access to healthcare". The search engines used were PubMed, CINHAL Complete, ProQuest Nursing, and Allied Health Source, and Google Scholar. All search engines were accessed through the United States University Library. Boolean operators such as "and" and "or" were used to broaden or define research where needed.

The first systematic review is entitled "Clinical Outcomes and Glycaemic Responses to Different Aerobic Exercise Training Intensities in Type 2 Diabetes", and includes 27 randomized control trials with a total of 1372 participants were evaluated for their results (Grace, Chan, Giallauria, Graham & Smart, 2017). The study was published in Cardiovascular Diabetology and included adults over the age of 18. RCTs included in this review were six weeks or longer in duration and all participants had elevated HbA1c levels. Studies of Type1 diabetes were excluded. HbA1c levels were used to determine impact of exercise as well as peak VO2 as HbA1c levels may not be impacted at the 6-week timeframe. Also recorded were baseline lean body mass, BMI, body composition, fasting glucose and insulin (Grace et al., 2017). Duration of exercise, frequency and intensity of exercise, and the length of the exercise program were also recorded. Resistance training studies were excluded as they do not impact peak VO2. All study groups were compared to a control group. More than 13 studies included were conducted poorly and nine out of 27 studies did not clearly report the method of randomization. Only four studies reported blinding. Exercise intensity was only reviewed in five studies. A systematic search was used to identify studies using MEDLINE from 1985 to September 2, 2016, CINHAL, SPORTDiscus, Cochrane Controlled Trial Registry from 1966 to September 2, 2016, and Science Citation Index. The strategy used was a mix of free text terms and MeSH for key concepts. The searches were limited to randomized controlled trials that included aerobic activity of individuals with T2DM who were 18 years of age and older and lasted for two weeks (Grace et al., 2017).

This first systematic review of exercise revealed a 0.71% decrease in HbA1c levels with moderate exercise and a 1.03% decrease in HbA1c with intense exercise performed at peak levels (Grace et al., 2017). The study duration was two weeks. Included were 737 exercise groups and 636 control groups. This review evaluated exercise intensity on the control of HbA1c levels. The study discusses the benefits of lifestyle modification, namely diet and exercise, as beneficial to those with Type 2 Diabetes and HbA1c control. The focus, however, was on exercise intensity. It was discovered that various modalities of exercise result in different effects on HbA1c levels. Combining aerobic activity and resistance training is superior at controlling blood glucose levels for those with T2DM according to this article (Grace et al., 2017). For example, it was discovered that one 4-minute session of High-Intensity Interval Training (HIIT) was not as effective as four 4-minute sessions on HbA1c levels. However, according to this study, moderate exercise is still considered preferable as clinical improvements are seen at a moderate intensity and can be performed by most people (Grace et al., 2017). The primary outcome data in all RCTs were HbA1c levels. The instruments of measurement were HbA1c levels, fasting blood glucose, and weight loss validating the results (Grace et al., 2017).

This systematic review includes Level I evidence and is at the top of the evidence pyramid scale. The strengths of this article include a clear review of studies and benefits supporting a moderate exercise program. Additionally, the number of randomized control trials (RCTs) and participants provides for a detailed analysis. The study points out a weakness in findings related to exercise and red blood cells. Exercise increases red blood cells, and red blood cell lifespan is approximately four months in length. As this study points out, research on the impact of physical activity on HbA1c levels should last a minimum of four months to coincide with the red blood cell lifespan. HbA1C levels are a twelve-week look at plasma glucose concentration. Other parameters for testing should be included for a closer look at exercise related to blood glucose levels in the long run. The studies in this review lasted six weeks or longer, with the highest amount of time being twelve weeks or less (Grace et al., 2017). All findings were consistent and support exercise as a viable means for controlling blood glucose levels. Also, the longer the study continued, the more significant the impact on HbA1c levels. This supports testing subjects with elevated HbA1c levels in exercise programs for longer than twelve weeks (Grace et al., 2017). The more significant analysis could be obtained with a longer duration of studies related to exercise and HbA1c control. Additionally, this study has weaknesses in the RCTs and many should not have been included. Still, there is evidence that supports the common protocol of placing those with T2DM on an exercise regimen to help control blood sugar.

The second study in these summaries, another systematic review, is entitled "The Interpretation and Effect of a Low-Carbohydrate Diet in the Management of Type 2 Diabetes" and was published in The European Journal of Clinical Nutrition (Huntriss, Campbell & Bedwell, 2018). This systematic review approaching HbA1c control with diet was related to a low carbohydrate diet. The low carbohydrate diet resulted in a decrease in HbA1c levels of 0.28%, whether participants consumed 50 grams or 120 grams of carbohydrates per day (Huntriss et al., 2018). Eighteen studies were included in this review, with a total of 2204 participants that were 18 years of age and older. Seven of the studies analyzed HbA1c levels at three months, eight studies analyzed HbA1c levels at six months, and ten studies analyzed HbA1c levels at one year. At the trial’s end, HbA1c was analyzed, and data were available from seventeen studies. Not all studies included could effectively be blinded as participants could evaluate the diet they were to follow. A moderate carbohydrate diet resulted in twelve of the seventeen studies reporting a decrease in HbA1c levels, while four studies reported no change. One study reported the same effects as the control group and favored not reducing carbohydrate intake. The primary outcome data in the RCTs reviewed was HbA1c levels (Huntriss et al., 2018). Fifteen out of eighteen studies were considered to at high risk for bias in six of the criteria. RCTs were searched for using studies of individuals with T2DM who were over the age of 18. CINHAL, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, ProQuest, ISRCNT, and opengrey.eu were used for the search. Studies containing data after one year on a low-carbohydrate diet were selected (Huntriss et al., 2018).

This study is a Level 1 evidence systematic review placing it at the top of the evidence pyramid scale. Shortcomings of the study were trials having different definitions of low carbohydrate. Some studies used a very low carb diet of fewer than 50 grams of carbohydrates per day. Other studies that considered their diet low or moderate in carbohydrates came in at 120 grams of carbohydrates per day. Adherence to diet was low, particularly in the groups that consumed 50 grams of carbohydrate per day. Several participants and RCTs reviewed add strength to this review, but the conclusion was less than helpful. While there is some evidence that a lower carbohydrate diet can positively impact HbA1c levels, it was considered inconclusive overall, with further studies needed (Huntriss et al., 2018). The unclear definition of low- and moderate-carbohydrate in this review weakens the overall strength of the study and carbohydrate control does not appear to be a major factor in controlling HbA1c levels. For this proposed project, this study should be eliminated.

The third study in these summaries is entitled "." The study was published in The International Journal of Environmental Research and Public Health (Liu, Ye, Chen, Zhang, Kuo & Korivi, 2019). This second systematic review of activity revealed that low-moderate intensity resistance exercise resulted in a 0.23% decrease in HbA1c levels while the high-intensity group experienced a 0.61% decrease in HbA1c levels (Liu et al., 2019). The literature search for this review used SportDiscus, PubMed, Google Scholar, ScienceDirect/Scopus, EMBASE, and WanFang. All article available in English through September 2018 were searched using keywords such as “strength training” and “resistance training” along with “type 2 diabetes” (Liu et al., 2019). Titles and abstracts were screened for relevance related to the search criteria and further reviewed once appropriate articles were identified. Along with RCTs of individuals with T2DM written in English, resistance exercise programs of six weeks or greater were identified. There were twenty-four articles and 962 participants included in this review. Of the participants involved, 491 were in the exercise group, and 471 were in the control group. Groups were categorized as the low-moderate intensity in resistance training or high-intensity resistance training. There was also a control group that did not take part in resistance exercise. The report discusses the importance of comparing resistance training to aerobic activity in that aerobic activity can be difficult for overweight or obese individuals (Liu et al., 2019). All but one of the trials had a high risk of bias for blinding, though the authors of this study believe that did not compromise the validity of the study (Liu et al., 2019).

Performing resistance exercises can be more comfortable for those with mobility issues and can be done in-home making it convenient. Results revealed that those participating in low-moderate intensity resistance training only experienced a moderate decrease in insulin levels. The groups that performed high-intensity resistance training had significant reductions in insulin levels. However, low-moderate and high-intensity resistance training substantially lowered HbA1c levels, with the most significant lowering seen in the high-intensity group. The primary measurement outcome of this study was HbA1c levels. The report concludes that high-intensity resistance training improves insulin resistance very effectively and lowers HbA1c levels and is more beneficial than aerobic exercise at managing T2DM (Liu et al., 2019).

This study is a Level 1 evidence systematic review placing it at the top of the evidence pyramid scale. The strengths of this study are the vast number of RCTs and participants reviewed. Additionally, it is one of few studies that compare the effects of resistance training on those with T2DM to aerobic activity with definitive results. This study's weaknesses lie in the lack of timeframes of the RCTs included (Liu et al., 2019). Although the duration of exercise is not clear, this study provides information worth including in this proposed study as it is one of very few studies that evaluates the differences between resistance training and aerobic activity on HbA1c levels allowing for physical activity that may be more manageable for those who are overweight or obese (Liu et al., 2019).

The fourth study summarized is entitled "Exercise Training Modalities in Patients with Type 2 Diabetes Mellitus" and was published in The International Journal of Behavioral Nutrition and Physical Activity (Pan et al., 2018). This third systematic review of exercise control of HbA1c levels revealed that aerobic exercise compared to resistance exercise programs resulted in a 0.30% decrease in HbA1c levels, whether the plans were supervised or unsupervised. The study protocol for this review was registered with the International Prospective Register of Systematic Reviews (PROSPERO) (Pan et al., 2018). Searches were conducted in PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and EMBASE in April 2017 for articles and systematic reviews. Keywords used were “type 2 diabetes”, “exercise”, “aerobic exercise”, “strength exercise”, and “combination exercise” (Pan et al., 2018). Inclusion for the review required participants be over the age of 18 with a T2DM diagnosis (Pan et al., 2018). The review included 37 studies and 2208 participants with T2DM. This study evaluated literature that compared aerobic activity to resistance exercise and a combination of both. The primary measurement of outcome in this study was HbA1c levels, with blood lipids and weight loss being second and third. The study further compared supervised exercise with unsupervised exercise. The articles reviewed for this study have an unclear risk of bias. The scales of measurement were HbA1c levels, fasting blood glucose, weight loss, and blood lipid profiles. There were no inconsistencies reported between studies (Pan et al., 2018).

The findings of this study were that supervised exercise, whether aerobic or resistance, had little improvement over unsupervised activity when it came to HbA1c levels. The study did reveal that the combination of resistance exercise and aerobic exercise yields the most considerable decrease in HbA1c levels. Other markers were measured with the different exercise groups due to the correlation between T2DM and cardiovascular disease. Increase insulin sensitivity as a result of aerobic activity improves lipid profiles, and aerobic activity appears to be more beneficial at lowering LDL cholesterol than resistance activity (Pan et al., 2018). Combined exercise resulted in a 0.47% decrease in HbA1c levels (Pan et al., 2018).

This study is a Level 1 evidence systematic review placing it at the top of the evidence pyramid scale. Some scales of measurements, such as quality of life, did not have the same baseline in the RCTs included in the study. Additionally, the duration of exercise sessions and the duration of the length of studies were not included weakening the study to some degree. This study's strengths are the breakdown of aerobic exercise, strength training, and a combination of activity and their respective impact on HbA1c levels (Pan et al., 2018). Due to more evidence on type of exercise improving HbA1c levels, this proposed study should include this systematic review.

The fifth and final systematic review is entitled "Behaviour Change Techniques Targeting Both Diet and Physical Activity in Type 2 Diabetes" and was published in The International Journal of Behavioral Nutrition and Physical Activity (Cradock, ÓLaighin, Finucane, Gainforth, Quinlan, & Ginis, 2017). RCTs that included exercise and diet related to individuals with T2DM were searched for using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). RCTs of any duration from January 1, 1975 through January 6, 2015 included as long as there was a dietary and exercise intervention. Participants had to be over the age of 18 with a current diagnosis of T2DM (Cradock et al., 2017). The review does not compare the effectiveness of diet to an exercise program to control HbA1c levels. Instead, it discusses the use of both diet and exercise together. Thirteen RCTs and evaluations made at three, six, nine, twelve, and twenty-four months. The primary measurement outcome in this study was HbA1c levels, with weight being secondary. All RCTs included evaluated both diet and exercise impact on HbA1c levels. Low or unclear risk of bias was reported.

Low carbohydrate or a Mediterranean diet was used in combination with exercise. The review discusses the difficultly in modifying more than one behavior at a time. However, the results are that combining training with diet is a superior approach to controlling HbA1c levels. Behavior change techniques (BCTs) were evaluated, and it was concluded that BCTs outside of diet and exercise do not have much impact on HbA1c levels. However, BCTs were said to create a feeling of control for the individual with T2DM and increased confidence in self-management of their condition. It was also found that HbA1c levels improved at the three- and six-month mark, but are not sustained after that time (Cradock et al., 2017). Though it was unclear who was following the low carbohydrate diet and who was following the Mediterranean diet, the first three months resulted in a decrease of 1.11% HbA1c. After six months, the reduction in HbA1c levels was 0.67%. At the end of the twenty-four-month analysis, the reduction in HbA1c levels was 0.53% (Cradock et al., 2017).

This study is a Level 1 evidence systematic review placing it at the top of the evidence pyramid scale. The strengths of this review are the RCTs used and the evaluation of both diet and exercise use to improve HbA1c levels. Additionally, the length of the study spanned twenty-four months. The weakness in this review is the difficulty in understanding how many participants were part of the RCTs used. It is also unclear how many participants followed a low carbohydrate diet or a Mediterranean diet. Diet and exercise combined have the most positive impact on controlling HbA1c levels (Cradock et al., 2017). As this review has quality evidence that diet and exercise combined can have a positive effect on HbA1c levels, and the use of BCTs increase confidence in managing T2DM, this proposed study should include this systematic review.

Interventions of Care

The proposed interventions include a vegetarian/vegan/Mediterranean diet, exercise a minimum of three days per week, and behavior control techniques (Cradock et al., 2017). These proposed interventions begin with identifying those with T2DM. The most significant decrease in HbA1c levels was with a combined diet and physical activity approach (Cradock et al., 2017). Once a diagnosis of T2DM is made, proactive teaching should occur. Weight reduction is directly linked to a decrease in T2DM (Cradock et al., 2017). A moderate calorie diet that is low in sugar and animal protein and fat, and moderate in dairy appears to be a beneficial approach to managing HbA1c levels. A decrease of 0.53% HbA1c levels was reported with the combination of diet and exercise making a manageable exercise program appropriate (Cradock et al., 2017).

A combined approach to exercise that includes both aerobic activity and resistance training resulted in a 0.47% decrease in HbA1c levels (Pan et al., 2018). This is the greatest return on investment of physical activity. This proposed intervention includes two days a week of resistance training and a minimum of three days a week, 45 minutes per day of moderate aerobic activity such as walking. Combing exercise with diet will result in better glucose control of those with T2DM (Pan et al., 2018).

The third component of this intervention of care includes behavior control techniques (BCTs). Of the most useful BCTs, instructions on how to perform a behavior, practice and rehearsal of behaviors, and action planning, and demonstration were the most useful elements (Cradock et al., 2017). This supports that observational learning can empower individuals to make change (Cradock et al., 2017). This is an importance component of this proposed intervention of care that should be included.

Though further research needs to be completed, walking three days per week and resistance training two days per week for a minimum of 45 minutes per day will be the standard starting regimen. Although this area is unclear in research, the diet will lean toward vegetarian/vegan with the Mediterranean diet as an option where compliance may be low. More research is needed in this area as well. Weekly phone calls from a local clinic and support groups will be offered to support self-management of the disease process and reinforce the importance of monitoring blood glucose at home and having HbA1c screenings every 90 days. Adjustments to diet and exercise plans will be reviewed every 30 days to support compliance and evaluate the effectiveness of the bundle of care.

Implications of Using Interventions of Care

The potential contributions to T2DM care with this proposed project are greater self-management of HbA1c levels leading to a better quality of life. Research to this point has helped develop EBP to support the care of individuals with T2DM. By designing a plan of care that includes physical activity and diet combined, patient education, community support to help sustain lifestyle changes, and using this bundle of care in practice, more significant management of the T2DM disease process can occur. This bundle of care can be implemented in the practice of primary care providers and nurse practitioners, bringing attention and support for self-management into the communities. While there is still research to be done, many cases of T2DM can be managed without pharmacotherapy (Levy, 2019). Decrease medication management of T2DM reduces the cost of care and helps to put control of T2DM in the hands of the patient.

References