Running head: DIABETES PREVENTION INTERVENTIONS FOR ADULTS

Diabetes Prevention Interventions for Adults Theresa Richardson College of Nursing, USF

Word Count: 2,107

DIABETES PREVENTION INTERVENTIONS FOR ADULTS Abstract

Clinical Problem: According to the American Diabetic Association (2011), 1.9 million new cases of diabetes were diagnosed in 2010 in adults ages 20 and older. According to Ma et al. (2013), weight management, a modifiable risk factor of Type 2 Diabetes, is a weak point of clinical practice today. Further analysis of effective lifestyle interventions should be done to demonstrate how to improve patient outcomes in a clinic setting. Objective: To evaluate research studies on current clinical practice counseling interventions that emphasis lifestyle change to prevent the incidence of Type 2 Diabetes. Data Sources: Using PubMed, three relevant peer reviewed randomized control trials were found in order to evaluate the counseling techniques used such as standard care, coach lead group, oneon-one, and home DVD sessions. Keywords used were: prevent, diabetes, and lifestyle. One guideline was found using the Agency for Healthcare Research and Quality (AHRQ). Results: According to the National Guideline Clearinghouse (2012), in order to prevent or delay the incidence of T2D, patients should lose 7% body weight and increase physical activity to at least 150 minutes a week. The guidelines also recommend that patients receive follow up visits in order to increase the success of the patient (National Guideline Clearing House, 2012). In the studies conducted by The Diabetes Research Group (2002) and Ma and Colleagues (2013), both goals of 7% body weight loss and at least 150 minutes of moderate physical activity were met by participants in the most effective intervention groups. In those settings, the leaders facilitating the counseling motivated their participants and follow up visits were made. Conclusion: All three studies demonstrated that with an adequate amount of education improved patient outcomes are possible.

DIABETES PREVENTION INTERVENTIONS FOR ADULTS Diabetes Prevention Interventions for Adults

In the United States (US), close to 70% of adults are estimated to be overweight or obese and many are at risk for type 2 diabetes (T2D) as a result (Ma et al., 2013). Standards of medical care of diabetes guidelines recommend that lifestyle interventions for weight management should be used as a way to prevent T2D (National Guideline Clearing House, 2012). The question now is, what is the best way to incorporate weight management interventions into clinical practice in a clinic setting that will elicit the best patient outcome. The focus of this paper is to compare and contrast the different counseling interventions that have been used to educate and motivate patients on the importance of lifestyle changes in order to prevent T2D. To find research on this issue the following PICOT question was formed. In adults at risk for Type 2 Diabetes, how do different methods of health counseling in diabetic prevention programs affect the delay of diabetes over a year? Literature Search To obtain relevant peer review articles to evaluate for this paper on diabetes prevention interventions, the search engine used was the PubMed database. Pertinent keywords that were used to find the articles used were prevent, diabetes, and lifestyle. One guideline was obtained using the Agency for Healthcare Research and Quality (AHRQ). The three articles and one guideline were found and will be used to determine how effective different counseling techniques are when used in nursing practice to educate patients on how to prevent or delay the onset of (T2D). Literature Review The Diabetes Prevention Program Research Group (2002) conducted the largest randomized control trial (RCT) of interventions for diabetes prevention. The aim of this study

DIABETES PREVENTION INTERVENTIONS FOR ADULTS was to reduce the incidence of T2D with lifestyle intervention or metformin. The participant sample consisted of 3,234 nondiabetic patients with increased fasting blood glucose and they were randomly assigned to one of three intervention groups. The participants had to be at least

25 years of age, body mass index (BMI) of 24 or higher, and have a fasting blood glucose of 95125 mg/dL. Participants were excluded if they were taking any medications that changed their glucose tolerance or had any illness that could reduce their life expectancy. The three intervention groups consisted of 1.) standard recommendations plus 850 mg of metformin twice daily, 2.) Standard recommendations plus a placebo, and 3.) an intensive program of lifestyle modification. The participants in the metformin and placebo groups that were given standard lifestyle modification information were required to attend a 30-minute individual session once a year. The same two groups were encouraged to follow the food guide pyramid, to loose weight, and to increase their physical activity but were not given any specific goals. The intensive group was given a 16- session curriculum that was taught one-on-one by a case manager. These participants were educated on proper diet, exercise, and behavior modification. They were also given the specific goals of maintaining a weight reduction of at least 7% and to engage in moderate physical activity for at least 150 minutes each week (The Diabetes Prevention Program Research Group, 2002). All three groups were followed for 2.8 years after the study began (The Diabetes Prevention Program Research Group, 2002). The results showed, the participants in the intensive lifestyle intervention group demonstrated a greater weight loss and increase in leisure activity than participants assigned to the standard groups. Based on a desired p < 0.05 to calculate significance of the interventions, average weight loss after one year in the placebo group was 0.1 kg, metformin 2.1 kg, lifestyle was 5.6 kg, with a significant value of p < .001. In fact, 50% of

DIABETES PREVENTION INTERVENTIONS FOR ADULTS

the participants, by the end of the 16 session curriculum, achieved the goal of 7% or more weight loss and 74% met the goal of 150 minutes of exercise per week by keeping track of their hours through an activity log on their own. All together, the incidences of diabetes conversions were lower in the intensive lifestyle and metformin groups compared to the standard lifestyle and placebo group. Over the course of 2.8 years the incidents of diabetes in the intensive lifestyle group was 58% percent lower compared to 39% in the metformin group. The same research group conducted a follow up on this study 10 years later (The Diabetes Prevention Program Research Group, 2009). They found that the intensive lifestyle group that originally lost the most weight had gradually regained about 1 kg back by the time of the 10-year outcomes study and the metformin group that had lost the least amount of weight by the end of the original 2.8 years regained the weight back. Ma and colleagues (2013) conducted a translation study of the Diabetes Prevention Program (DPP) to determine if the lifestyle intervention, for weight loss to reduce the incidence of T2D, could adequately translate into a primary care setting. The study included adult participants ages 18 and over, a BMI greater than 25, and an impaired fasting blood glucose of 100-125 mg/dL, which showed that they had the presence of prediabetes (pre-DM). Participants were excluded if they had serious medical issues such as a stroke, psychiatric conditions, or extreme life changes such as pregnancy or were going to be moving out of the area. The 241 participants that were eligible were then randomized into three groups with different counseling interventions. A coach in a group setting facilitated the first group of participants, the second group was given a set of dvds to watch on their own, and the third group was standard care. The standard care group was given no information about weight loss nor given weight loss goals whereas the

DIABETES PREVENTION INTERVENTIONS FOR ADULTS other two group interventions were to complete a 3-month intensive intervention phase and 12month maintenance phase. The coach-led group was conducted in person and they met once a week for 12 weeks. This group was exposed to healthy cooking and exercise habits and then

motivated to incorporate them in their every day life. Constructive ways they were provided this information were food tastings, led by a dietician and 45-minute guided physical activities during their group time. The home DVD self-guided group did initially meet for an orientation class about the DVDs but the rest was self-managed at home. The group led participants used www.heart360.org to set goals and manage their progress and were given a scale and pedometer to help track their progress. All groups were emailed biweekly reminders, monthly motivational messages, and were able to email questions and receive answers within a few days. Only the coach-led groups received personalized emails back as well as feedback on their heart360 progress. Primarily, the study aimed to decrease BMI from baseline to 15 months. At baseline, participants had a mean BMI of 32.0 kg/ml and at 15 months the coach-led intervention decreased by 2.2 kg/ml, self- directed decreased by 1.6 kg/ml, and standard care decreased by only 0.9 kg/ml. The difference between the coach-led group and the standard care group demonstrated a significant difference of p < .001, and the difference between the coach-led group and the self- directed group demonstrated a significant difference of p= .03. Results showed the same trend in weight loss. According to the findings, the coach-led intervention was the most effective in improving participants outcomes based on the results. (Ma et al, 2013) The final study, conducted by Cole and colleagues (2013) was a randomized control trial designed to compare the health outcomes of patients that have been diagnosed with prediabetes that either attended individualized counseling sessions or three 90 minute group sessions once per month for 3 months. There were 94 participants that were randomized with 69% completion

DIABETES PREVENTION INTERVENTIONS FOR ADULTS rate during 1 year. The participants that were included in this study were 18 years of age and

older, spoke English, and were already diagnosed with prediabetes. This meant they had a fasting blood glucose of 100-125 mg/dL. Participants were excluded if they already had a diagnosis of diabetes or if they did not go to the initial prediabetes class. All included participants had to attended a 3-hour class that addressed the issue of prediabetes and then were randomized in one of the two groups. In the group sessions there were 6 to 8 participants per group where the facilitator would greet, introduce one another, and create a positive group atmosphere. Each of the group participant would also get 10 minutes of individual time to discuss their SMART (specific, measurable, achievable, realistic, and time-based) goals relating to lifestyle changes and address any challenges they fell they may encounter. The group intervention participants had additional time to ask questions about their progress and were given a scheduled follow up visit. The standard care participants attended at least one 45-60 minute individual counseling session. During these sessions, if they attended more then one, their outcomes and any progress that was made in lifestyle modifications since the large group orientation were discussed. During these visits they could get additional education, develop goals, and schedule another visit if they wanted to. The primary outcome was to have a decrease in the fasting blood glucose. Some of the secondary outcomes were to have a decrease in weight, BMI, blood pressure, and glycosylated hemoglobin (HgA1C). About 70% of the participants reported exercising but only 15% met the recommended 150 hours a week. Out of the participants in the individual counseling group, 94% chose to not only attend the initial 45-60 minute individual session but also made follow up appointments. Both intervention groups exhibited improved health outcomes during the first 3 months but when considering the p-values based on the primary outcome of a decreased fasting

DIABETES PREVENTION INTERVENTIONS FOR ADULTS blood glucose by 10mg/dL, only 41% (p=. 002) of the group intervention and 55% (p=. 026) standard care group met that goal, which was not considered a significant difference. Both groups lost weight but neither met the 5% goal that they were aiming for and neither group was able to maintain the weight loss. Both groups also regained weight by the time they were assessed at the 1-year mark (Cole, Boyer, Spanbauer, Sprague & Bingham, 2013) Synthesis The diabetes prevention counseling interventions that produced the most effective outcomes in patients, were the interventions that involved an intensive curriculum to lower the patients weight and increase physical activity. These outcomes were achieved in both the group settings as well as the individual counseling intervention demonstrated in the studies conducted by Ma and colleagues (2013) and the Diabetes Prevention Research Group (2002). In those settings, the leaders facilitating the counseling motivated the participants. All three studies showed that with adequate education and motivation improved patient outcomes are possible.

One gap found in the research conducted by Ma and colleagues (2013) and Cole and Colleagues (2013) compared to The Diabetes Preventions Program Research Group (2002) was how the interventions affected participants of differing cultures. Only the DPP took into consideration cultural differences, whereas the other two studies by Ma and Colleagues (2013) and Cole and Colleaguess (2013) participants were majority Caucasian. Further studies need to be done in order to evaluate how these interventions affect various cultural groups. One of the great limitations in the study conducted by Cole and Colleagues (2013) was the small sample size and poor completion rate of just 69% which may have limited their results. According to the National Guideline Clearinghouse (2012), in order to prevent or delay the incidence of T2D, patients should lose 7% body weight and increase physical activity to at

DIABETES PREVENTION INTERVENTIONS FOR ADULTS least 150 minutes a week. The guidelines also recommend that patients receive follow up visits in order increase the success of the patient (National Guideline Clearing House, 2012). In the studies conducted by The Diabetes Research Group (2002) and Ma and Colleagues (2013), both

goals of 7% body weight loss and at least 150 minutes of moderate physical activity were met by participants in the most effective intervention groups. Clinical Recommendations Currently, nutrition and exercise is a general recommendation for overall heath but for those patients that are at a higher risk of converting to T2D, diabetes prevention counseling may be needed to make lifestyle modifications. In order to begin to see improved patient outcomes the nurses in the clinic setting need to incorporate the findings from these studies into their practice. Some clinics and hospital settings have access to diabetic educators and wellness educator nurses. In relation to the PICOT question, if an interactive group class or a one on one session with follow-up visits could be implemented utilizing those resources the clinic could begin to see a decreased number of patient convert to T2D.

DIABETES PREVENTION INTERVENTIONS FOR ADULTS References American Diabetes Association (2011). Diabetes Statistics. Retrieved from http://www.diabetes.org/diabetes-basics/diabetes-statistics/

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Cole, R.E., Boyer, K.M., Spanbauer, S.M, Sprague, D., & Bingham, M., (2013). Effectiveness of Prediabetes Nutrition Shared Medical Appointments. The Diabetes Educator. 39(3). 344353. Doi:10.1177/0145721713484812 Ma, J., Yank, V., Xiao, L., Lavori, P.W., Wilson, S.R., Rosas, L.G., & Stafford, R.S. (2013). Translating the diabetes prevention program lifestyle intervention for weight loss into primary care. The Journal of the American Medical Association. 173(2). 113-121. doi:10.1001/2013.jamainternmed.987 National Guideline Clearinghouse. (2012). Standards of medical care in diabetes. IV. Prevention/delay of type 2 diabetes. Diabetes Care. Retrieved from http://guideline.gov/content.aspx?id=35247&search=diabetes+prevention The Diabetes Prevention Program Research Group. (2002). Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. New England Journal of Medicine. 346(6). 393-403. doi:10.1056/NEJMoa012512 The Diabetes Prevention Program Research Group. (2009). 10-year follow-up of diabetes incidence and weight loss in the diabetes prevention program outcomes study. Lancet. 374(9702). 16771686. doi:10.1016/S0140-6736(09)61457-4

DIABETES PREVENTION INTERVENTIONS FOR ADULTS Table 1: Summary of Studies Review Reference Aims Design & Measures Cole, R.E., Boyer, To compare Randomized K.M., Spanbauer, the health control Trial S.M, Sprague, D., outcomes of & Bingham, M., patients that Weight, BMI, (2013). have been blood Effectiveness of diagnosed pressure, lipid Prediabetes with profile, Nutrition Shared prediabetes fasting blood Medical that either glucose, and Appointments. The attended HgA1C Diabetes individualized EDUCATOR. counseling These 39(3). 344-353. sessions or measures Doi:10.1177/01457 three 90were assessed 21713484812 minute group at baseline, 3 sessions once months, and 1 per month for year. 3 months.

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Sample 94 participants Caucasian (64%), Male (54%), Included: Age > 18 years old, Fluent in English, Diagnosis of prediabetes (FBG- 100125 mg/dL)

Outcomes/statistic s The sample: 80% remained by month 3 69% completed the 1 year assessment Repeated ANOVA measures were taken at baseline, 3 months, and 1 year. Both groups exhibited improvements but there was no significance between the two groups. Neither group met the 5% weight loss goal, any weight loss they were unable to maintain, and both groups experienced weight gain by the one year follow- up The Sample: Participants in the coach-led group attended their group and average of 75% of the time. Only 4 of the participants in the self directed group did not attend the orientation. In the Coach-led group: Mean change in BMI was -2.2 Weight was -6.3 kg Achieved 7% weight loss goal was 37%. Self Directed dvds group: Mean change in

Ma, J., Yank, V., Xiao, L., Lavori, P.W., Wilson, S.R., Rosas, L.G., & Stafford, R.S. (2013). Translating the diabetes prevention program lifestyle intervention for weight loss into primary care. The Journal of the American Medical Association. 173(2). 113-121. doi:10.1001/2013.ja mainternmed.987

To determine if the use of the lifestyle intervention of weight loss, as the primary factor, to reduce the incidence of T2D could adequately translate into a primary care setting. The first group was facilitated by a coach in a group setting, the second group

Single Center, Randomized control trial Change in BMI from baseline to 15 months. Weight, BMI, Blood pressure were measures at 3,6, and 15 months.

241 participants 47% female 78% nonhispanic white Included: Age > 18 years, BMI > 25 Presence of prediabetes (FBG 100125 mg/dL) or metabolic syndrome.

DIABETES PREVENTION INTERVENTIONS FOR ADULTS was given DVD to watch on their own, and the third group was standard care BMI: -1.6 Weight: -4.5 kg Achieved 7% weight loss goal was 35.9%. Standard care group: Mean change in BMI: -.9 Weight: - 2.45 kg Achieved 7% weight loss goal was 14.4 %.

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When looking at the primary outcome of decreasing BMI. The difference between the coach-led group and the standard care group demonstrated a significant difference of p < .001, and the difference between the coach-led group and the self- directed group demonstrated a significant difference of p= .03 For women, weight loss was significantly greater in coach-led group than both other groups. For men, both self directed dvds and coach led groups resulted in significantly greater weight loss than the standard care. The Sample: At the close of the study: 99.6 % of the participants were alive, 92.5% had attended a scheduled visits within the precious 5 months.

The Diabetes Prevention Program Research Group. (2002). Reduction in the incidence of type 2 diabetes with lifestyle intervention or

The study looked at the reduction in the incidence of T2D with lifestyle intervention or metformin.

Multi- center, Randomized control trial Weight, BMI glucose and HgA1C were measured.

3234 nondiabetic patients Caucasian (54.7%) African American

DIABETES PREVENTION INTERVENTIONS FOR ADULTS metformin. New England Journal of Medicine. 346(6). 393-403. doi:10.1056/NEJM oa012512 The three intervention groups consisted of 1.) Standard recommendati ons plus 850mg of metformin twice daily, 2.) Standard recommendati ons plus a placebo, and 3.) an intensive program of lifestyle modification. (19.9%) Hispanic (15.4%) American Indian (5.3%) Asian (4.4%) Included: Age > 25 BMI > 24 (>22 in Asian) Plasma glucose concentrate of 95125mg/dL

13 Based on a desired p < 0.05 to calculate significance of the interventions, average weight loss after one year in the placebo group was 0.1 kg, metformin 2.1 kg, lifestyle was 5.6 kg, with a significant value of p < .001. Lifestyle group: 50% achieved the goal of 7% weight loss and the end of the curriculum with 38% by the end of the 2.8 years. Of those participants who met the 7% weight loss goal, 74% also met the goal of 150 minutes per week by the end of the curriculum and 58% by the end of the 2.8 years. The lifestyle group: Weight: -5.6 kg Incidence of Diabetes: 58% lower

Self reported levels of leisure activities assessed annually with modifiable Activity Questionnaire