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O R I G I NA L A R T I C L E
The Effect of a Comprehensive Lifestyle
Modification Program on Glycemic Control
and Body Composition in Patients with
Type 2 Diabetes
Ji-Soo Yoo1, PhD, RN, Suk-Jeong Lee2*, PhD, RN, Hyun-Chul Lee3, MD, 1Professor, College of Nursing, Yonsei University, Seoul, Korea 2Full-time Instructor, Red Cross College of Nursing, Seoul, Korea 3Professor, College of Medicine, Yonsei University, Seoul, Korea 4Professor and Dean Emerita, Department of Medical-Surgical Nursing, College of Nursing, University of Illinois at Chicago, Chicago, Illinois, USA This paper describes the effects of a comprehensive lifestyle modification program (CLMP) on glycemic control and body composition in patients with type 2 diabetes.
Methods
This study was performed from October 2003 to April 2005, and used an experimental design with random assignment. The experimental group (n = 25) received CLMP for 4 months and follow-up ses-
sions for 9 months. CLMP included nurse-led education on exercise and diet, and counseling on stress man-
agement and self-monitoring of their diabetic health. The control group (n = 23) received a 1-hour educational
session on diabetic diet at the beginning of the study. Glucose level and body composition were measured in
both groups a total of five times: at baseline (pre-intervention) and at 0, 3, 6 and 9 months post intervention.
Results
Repeated-measures ANOVA showed that there were statistically significant differences in fast- ing blood sugar and HbA1c levels between the two groups (both p < .05). Both groups demonstrated statis-
tically significant changes in body composition over time, but there was no significant difference in the
pattern of change between the two groups.
Conclusion
CLMP is a useful program, and its multiple approaches by nurses as the leaders and coor- dinators appear to have positive and synergistic roles in improving and maintaining stable glucose leveland body composition in patients with type 2 diabetes. [Asian Nursing Research 2007;1(2):106–115] Key Words
behavior modification, body composition, diabetes mellitus, glycemic index INTRODUCTION
in 2000 have the risk of developing diabetes in theirlifetime (Narayan, Boyle, Thompson, Sorensen, & Diabetes has reduced life expectancy, and it is esti- Williamson, 2003). The New York Times recently mated that more than one third of Americans born carried an editorial about this crisis (Kleinfield, 2006).
*Correspondence to: Suk-Jeong Lee, PhD, RN, Full-time Instructor, Red Cross College of Nursing, 98 Saemoonangil
Jono-Gu, Seoul 110-102, Korea.
E-mail: [email protected]
Asian Nursing Research ❖ September 2007 ❖ Vol 1 ❖ No 2 Lifestyle Modification on Glycemic Control and Body Composition in Type 2 Diabetes Korea has also seen a sharp increase in diabetes in having a healthy lifestyle. Lifestyle, including an appro- adults in recent decades. The prevalence of diabetes priate diet and regular exercise, has been reported rose from 1% of the general population in the 1970s to control diabetes effectively (Klein et al., 2004).
to approximately 3% in the late 1980s. In 2000, However, substantial patience and effort are required 13.5% of males and 10.7% of females aged 30 years to form healthy eating habits and to continue regular or older had diabetes (Chae et al., 1998).
exercise. Hwang, Yoo, and Kim (2001) reported that Strict glycemic control has proven to be benefi- the compliance level of patients with type 2 diabetes cial in preventing and delaying complications related diminished over a 4-month period following inter- to diabetes (Stratton et al., 2000). However, control- vention by nurse researchers. Wing, Venditti, Jakicic, ling blood glucose without lifestyle change has not Polley, and Lang (1998) and Aas, Bergstad, Thorsby, been effective because unhealthy lifestyle choices Johannesen, and Birkeland (2005) reported that such as overeating, lack of exercise and stress are patients with diabetes could not maintain the effects known to influence glycemic control (Matsumoto, of glucose control over a 9-month period following Ohno, Noguchi, Kikuchi, & Kurihara, 2006).
intervention.These findings suggest that good lifestyle Studies that focused on education programs about habits and glucose control are difficult to maintain diet and/or exercise in patients with type 2 diabetes 4–9 months after the intervention, even though they have shown generally positive effects in the short showed positive effects during the intervention.
term (i.e., 3–6 months) (Norris, Engelgau, & Narayan, Previous lifestyle modification studies (Yoo et al., 2001). However, maintenance of the positive effects 2004; Yoo, Kim, & Lee, 2006) showed short-term requires more than a physical regimen. Behavior effect (0–2 months after finishing the program) of change and health outcomes are known to be influ- glycemic control; they have not yet reported the enced by reciprocal relationships between metabolic effect 6 months after finishing the program.
control and psychosocial variables such as anxiety For long-term effects, patients were required to and social support (Jirkovská & Hrachovinová, sustain their efforts to continue self-management 2005). Therefore, adding a behavior modification with increasing self-efficacy for control of diabetes program to the physical regimen would add more (Rapley & Fruin, 1999). Nurses should reinforce the potency to the intervention for glycemic control.
principle of self-efficacy when they teach patients In addition, patient success in adhering to the re- how to maintain a healthy lifestyle. Initially, nurses gimens is associated with interaction and relation- should focus on behavior change based on the gen- ship with heath care professionals including nurses eral sense of self-efficacy as suggested by Bandura (Bernard & Krupat, 1994; Lo, 1999). Hence, com- (1986), however, they should shift the focus to task- prehensive interventions in the clinic for patients specific efficacy to maintain the learned behaviors with diabetes are important for changing their and sustain various new skills (Raply & Fruin). For example, nurses should help patients build up their Yet, only a few studies to date have examined the self-confidence in managing healthy lifestyle for combined effects of physical and behavioral inter- controlling diabetes (general self-efficacy) and then ventions that are relevant to patients with diabetes teach them about balanced diet and daily exercise (Bijlan et al., 2005), nurse-led comprehensive inter- (task-specific efficacy) so that patients can continue ventions (Clarke, Crawford, & Nash, 2002) and the to practice newly acquired behaviors.
long-term effect of diabetes control interventions Therefore, we developed a comprehensive lifestyle modification program (CLMP), which was a nurse- Among chronic diseases, diabetes is one of the led education and counseling program incorporating most demanding in terms of behavioral changes key components of self-efficacy (Bandura, 1986) in (Cox & Gonder-Frederick, 1992). The outcome of addition to well-known variables such as diet and diabetes treatment is highly dependent on the patient Asian Nursing Research ❖ September 2007 ❖ Vol 1 ❖ No 2 The aim of this study was to describe the effec- CLMP (2 patients). A total of 7 patients in the tiveness of the CLMP on glycemic control and body control group were excluded because 4 patients composition in patients with type 2 diabetes and to changed drug regimen and 3 patients did not com- analyze the long-term effects of the CLMP.
plete follow-up tests. Thus, the experimental grouphad 25 patients, and the control group had 23patients, for a total of 16 males and 32 females.
Procedure
Design
Patients were recruited from a diabetes clinic which This study used a two-group experimental design they visited every 3 months for a doctor’s check-up.
with repeated measures and a random assignment Researchers approached patients while they were on a convenience sample of patients in a clinic.
waiting in the clinic and asked if they would be inter-ested in participating in a research project. With Subjects
their initial agreement, researchers then explained The study subjects consisted of 48 adult patients the study purpose and procedure. Researchers assured with type 2 diabetes who had visited the diabetic patients that their anonymity and the confidential- center of one of the university medical centers in ity of their responses throughout the study and in Korea. The study was conducted from October 2003 the publication would be maintained. Once written to April 2005. Inclusion criteria were: adults aged consent was received, patients were assigned to the over 35 years, diagnosed with type 2 diabetes, not experimental or control group per phase by tossing receiving insulin therapy, not having any change in a coin. Researchers obtained demographic informa- their therapy (e.g., drug dosage or any additional tion and made an appointment with all patients for drugs) for at least 3 months prior to the start of the the following measurements: fasting blood glucose, study, not having a history of psychiatric disorders HgA1c, body weight and height, and visceral fat thick- or eating disorder, and able to participate in regular ness (VFT). Medical history and medication profile were obtained from the patients’ medical records.
Sample size was estimated using a power table Two endocrinologists and one nursing professor (Machin, Campbell, Fayers, & Pinol Alain, 1997), and who had expertise in researching patients with dia- it showed that 32 was sufficient in both groups for betes established the content validity of the CLMP.
repeated measures, at a significance level of .05, cor- In addition, a pilot study was carried out to test the relation of .60, effect size of .60, and power of 80%.
feasibility of the study using the CLMP (see below).
However, we recruited 60 to accommodate possible Three nurse researchers carried out the pilot study attrition. The effect size was calculated based on a upon completion of group training of 3 hours on major outcome variable, such as glycosylated hemo- the protocol. The results finalized the CLMP con- globin (HbA1c), in a previous study that examined the effect of an exercise and diet program on improvingglucose index (difference between the means = 0.6, Pilot study
SD = 1) (Boule, Haddad, Kenny, Wells, & Sigal, 2001).
Ten participants with type 2 diabetes were enrolled Due to the nurse researchers’ schedule and avail- in the pilot study of the CLMP for 2 months. Edu- ability of space for group meetings, patients were cation on exercise and diet was carried out on a recruited in eight phases over 8 months. The number one-to-one basis, and it included walking 150 min- of patients ranged from 5–8 per phase. Five patients utes per week and consuming a calorie level that in the experimental group were excluded because was determined by the goal of 7% reduction in they had a change in drug regimen (3 patients) or weight in 6 months (Diabetes Prevention Program they participated in less than 50% of the 4-month Research Group, 2003) on an individual basis.
Asian Nursing Research ❖ September 2007 ❖ Vol 1 ❖ No 2 Lifestyle Modification on Glycemic Control and Body Composition in Type 2 Diabetes The results of the pilot study: glucose level was to be performed until the subsequent meeting for 10 reduced to 195 ± 61.47 mg/dl from the baseline level minutes. Following the weekly intervention period, of 230 ± 83.36 mg/dl; body weight was reduced by nine monthly follow-up sessions were provided to the 1.04% from the baseline of 60.03 ± 5.53 kg to 59.4 ± experimental group. Each follow-up session lasted 5.93 kg. However, the changes were not statistically 60 minutes, and the content was the same as that of the CLMP, but the lectures and discussion were more focused on participants’ questions and concerns, and increase the effect of the CLMP. First, exercise time counseling about difficulties that they had experi- was lengthened to 360 minutes/week (i.e., a 1-hour enced during the previous month. The experimen- walk per day for 6 days per week), which is more in tal group participated in the CLMP for 1 hour per line with recent guidelines (Wing & Hill, 2001).
week for 4 months, and the follow-up study contin- Second, instead of one-to-one sessions, small group ued for 9 months, which was a monthly visit, after discussion sessions were planned to facilitate peer intervention. The control group participated in a group support. Third, participants were asked to 1-hour educational group session on diabetic diet report twice weekly instead of daily on their diet and that is routinely taught by a dietitian in the clinic at exercise activities, because most expressed difficulty the beginning of the study. Patients in both groups in performing the tasks daily. Fourth, the goal of participated in a total of five measurements, four of reducing body weight by 7% in 6 months (or 1.75% in 2 months during the pilot study) was consideredideal as a long-term goal over a 12-month period.
Dependent variables
Glycemic indices were measured by fasting blood
Intervention: CLMP
sugar (FBS) and HbA1c. Body composition was mea- sured by body weight, body mass index (BMI) and We developed a CLMP based on the key components VFT. VFT was defined as the distance between the of self-efficacy (Bandura, 1986), and the Lifestyle anterior wall of the aorta and the internal face of Balance Program (Diabetes Prevention Program the rectoabdominal muscle perpendicular to the aorta Research Group, 2003). The CLMP focused on (Kim et al., 2004). VFT was calculated by sonogra- improving self-efficacy, including mastery of experi- phy (Logiq 9; GE Medical Systems, Milwaukee, WI, ence, vicarious experience, social persuasion, and USA). Patients were examined in the supine posi- reducing stress reactions (Bandura). The Lifestyle tion. Frozen images were obtained immediately after Balance Program served as a guide to the 4-month expiration to avoid the influence of respiratory sta- diet and exercise program of the CLMP.
Ethical considerations
Table 1 shows the content of the CLMP intervention.
Approval from the hospitals’ research and ethics It was composed of education on diet and exercise committees was obtained before initiation of the regimen, self-recording of regimens, counseling, stress study. Following the explanation about the purpose, management, and support using the principles of self- procedure, and confidentiality and anonymity of efficacy. Sixteen weekly meetings were composed of the study by the researchers, patients were asked 60-minute sessions. These included measurement and explanation about body composition and glucoselevel for 10 minutes; discussion about participants’ Data analysis
recording on diet consumption and exercise for 10 Data were analyzed using SPSS version 11.0 (SPSS minutes; lecture and discussion about main topics for Inc., Chicago, IL, USA) for Windows. Patient char- 30 minutes; and finally, explanation about the tasks acteristics are summarized using mean and standard Asian Nursing Research ❖ September 2007 ❖ Vol 1 ❖ No 2 The Contents of the Comprehensive Lifestyle Modification Program Introduction, importance of lifestyle modification, goal of the program using principles of Principles of exercise, risk for exercise.
Exercise methods (demonstration and practice of stretching).
Methods of recording exercise.
Standard weight, goal setting for weight goal, methods of recording calorie intake.
The standard weight for males was defined as “height (m) × height (m) × 22” kg, and for females as “height (m) × height (m) × 21” kg (Han, 2004).
Calorie goal is 1400–2200 per day with 55–60% carbohydrate, 15–20% protein and For normal levels of daily activity, standard weight in kg was multiplied by 30 calories, and for high levels of physical activity, standard weight was multiplied by 35 calories.
Exercise prescription (individual approach). Walking time was increased gradually depending on the participant’s condition. Walking goal was about 10,000 steps everyday, or more than 6 hours of brisk walking or swimming per week.
Exercise method (walking and aerobic exercise). Monitoring.
Intensity is 40–60% of maximum exercise capacity, which was calculated as [(maximum heart rate – heart rate at rest) × 0.4 (or 0.6) + heart rate at rest]. Participants not using the heart monitor learned how to calculate the range of 40–60% of maximum exercise capacity and to check their pulse rates during exercise.
Understand calories and fat, using food exchange list (grain, fat).
Using food exchange list (protein, vegetable, fruit).
Exercise method (strength exercise).
Readjustment of exercise prescription.
Tips for keeping healthy diet habits (i.e., avoiding extra meals, reducing alcohol and snack intake, keeping regular meal times, reducing the desire to overeat).
Tips for increasing physical activity (e.g., walking during phone call).
Demonstration of progressive muscle relaxation.
Education and counseling on positive thinking about the comprehensive lifestyle Sharing each other’s ways of managing stress related to diabetes.
Counseling about stress management related to diabetes.
deviation. The Mann-Whitney U test and χ2 test were analyzed by repeated-measures ANOVA, in were used to test the homogeneity of the two groups.
which main effect (group difference), time effect, Changes in study outcomes (FBS, HbA1c, body com- and interaction effect were examined. A p value of position) from baseline to 9 months post intervention less than .05 was considered statistically significant.
Asian Nursing Research ❖ September 2007 ❖ Vol 1 ❖ No 2 Lifestyle Modification on Glycemic Control and Body Composition in Type 2 Diabetes Baseline Characteristics of Study Participants Note. FBS = fasting blood sugar; HbA1c = glycosylated hemoglobin; BMI = body mass index; VFT = visceral fat thickness.
and decrease of 0.65% at 9 months from baseline.
The control group showed an increase of 0.6% at 6 Patient characteristics
months post intervention and an increase of 0.25% The mean age of the 48 patients was 55.2 ± 7.31 years at 9 months. HbA1c showed a time and group interac- (range = 38–75 years), and the mean duration of dia- tion (F = 3.088, p = .031), an effect of time (F = 2.742, betes was 9.8 ± 6.49 years (range = 1–23 years). There p = .047), and a difference between the two groups were no statistically significant differences between that was statistically significant (F = 10.114, p = .003).
the experimental and control groups (Table 2). No The results demonstrated statistically significant statistically significant differences were found at changes in HbA1c over time, and significant differ- baseline between the two groups with regard to the ences in HbA1c change pattern between the two glycemic indices and body composition (p > .05).
Glycemic indices
Body composition indices
Immediately after intervention, the experimental Repeated measures analysis of BMI and waist circum- group showed a 16.6 mg/dl reduction in FBS, while ference showed no significant time and group interac- the control group showed a 3.3 mg/dl reduction. At tion, and between group differences (both p > .05); 9 months post intervention, there was a 25.6 mg/dl however, the effect of time was statistically significant reduction in FBS in the experimental group, while the (both p < .05). The results indicate that both groups control group showed a 0.6 mg/dl increase. Analysis demonstrated statistically significant changes in BMI of FBS showed a time and group interaction that and waist circumference over time, but there was was statistically significant (F = 3.142, p = .016), but no significant difference in the pattern of change no effect of time (F = 1.704, p = .151), and a statisti- cally significant difference between the two groups(F = 8.827, p = .005). The results demonstrated sta-tistically significant differences in FBS change pat- DISCUSSION
Nurse researchers led the CLMP for patients with decrease of 0.91% at 6 months post intervention type 2 diabetes. The nurse’s role in the care of Asian Nursing Research ❖ September 2007 ❖ Vol 1 ❖ No 2 Note. Post 0 month = immediately after intervention; Post 3 mo (6 mo, 9 mo) = 3 months (6 months, 9 months) post intervention; FBS =fasting blood sugar; HbA1c = glycosylated hemoglobin; BMI = body mass index; VFT = visceral fat thickness; ⌬base = difference frombaseline.
patients with diabetes is diverse and includes not regard to glycemic indices such as HbA1c and FBS only providing physical care but also educating and over the 9-month follow-up period suggests that counseling on what constitutes a healthy lifestyle.
nurses’ education and counseling on diet and exer- The significant improvement shown in the experi- cise had a significant impact. All of the elements of mental group compared with the control group with the CLMP integrated together may have provided Asian Nursing Research ❖ September 2007 ❖ Vol 1 ❖ No 2 Lifestyle Modification on Glycemic Control and Body Composition in Type 2 Diabetes a synergistic effect on glycemic control and body might have been due to a lower mean BMI in our participants than in the participants of the other Our results showed more improvement in HbA1c studies (i.e., mean BMI in our study was 25.7, versus than the results of the meta-analysis reported by more than 33 in the other studies). It could also have Norris, Lau, Smith, Schmid, and Engelgau (2002), been due to the dietary habits of our participants, which showed a decrease in HbA1c of 0.28% at the who tended to overeat, particularly when eating 1–3-month follow-up and of 0.28% at 4 months and away from home. The median exercise time of our beyond. Additionally, a 0.97% decrease and 0.9% participants was 6 hours per week (range = 2–15 decrease at 6 and 9 months post intervention are hours) at 3 months post intervention. This exercise similar to the 1% reduction in HbA1c level noted by time is usually considered necessary for successful Norris et al. Our findings showed, in general, more long-term weight loss (Klein et al., 2004).When these improvement in HbA1c levels than previous studies two factors (dietary habits, exercise time) are con- that showed statistically significant reductions among sidered together, the lower reduction in weight loss participants with diabetes (Boule et al., 2001; Norris found in our study was probably due to excess food et al., 2001). For a 1% reduction in HbA1c, there was intake rather than insufficient exercise.
a 14% reduction in the mortality of patients with Patients with type 2 diabetes with excess visceral diabetes in the United Kingdom (Stratton et al., fat are at increased risk for negative health conse- 2000). This suggests that our finding of 0.90–0.97% quences. VFT as measured by sonography has proved reduction in HbA1c at 6 and 9 months post interven- to be strongly correlated with metabolic syndrome tion could have a similar impact on patient mortal- and cardiovascular disease (Kim et al., 2004); hence, ity. In addition, the statistically significant differences the reduced VFT found in this study could con- in repeated measures analysis found in glycemic tribute to the prevention of cardiovascular disease.
indices between the two groups indicate that the The control group in our study showed weight effect of the CLMP in our study was real and sus- reduction at 6 months post intervention and reduc- tainable up to 9 months post intervention.
tion in VFT at 3 months post intervention compared A few studies have shown that a lifestyle change with baseline measurements, but these differences program is as effective as other treatments such as were not statistically significant. This may be related drugs. For example, lifestyle changes were almost to the education (given at the beginning only) and twice as effective as metformin therapy in those with feedback on the measurements of the same vari- impaired glucose tolerance (Knowler et al., 2002).
ables (5 times) given to the control group patients.
Lifestyle changes were as effective as insulin treat- Given the increasing prevalence of diabetes in ment in improving glycemic indices in patients with Korea as well as in the rest of the world, nurses should poorly controlled type 2 diabetes (Aas et al., 2005).
provide comprehensive care that addresses both the However, it is important to take prescribed medica- physical and behavioral aspects of diabetes and tion consistently so that behavioral intervention can coordinate multidisciplinary therapeutic regimens.
be effective (Lauritzen et al., 2000). Our results sug- This care approach should be used in all clinical set- gest that CLMP is an added factor to pharmacological tings, including community health centers.
treatment because 68% of patients in the experi- The major weaknesses of this study are that the mental group were still taking medication to control results cannot be generalized to diabetes patients in other clinical settings, and the patients who partici- In our study, weight loss in the experimental group pated in this CLMP might have been more motivated was 1.03 kg (1.6%) at 9 months post intervention, for the treatment than the average patient with type and this was of a smaller magnitude than that found 2 diabetes, which may therefore have contributed in other studies (Agurs-Collins, Kumanyika,Ten Have, to the positive outcome in this study. One could & Adams-Campbell, 1997; Wing & Hill, 2001). This also question which particular element of the CLMP Asian Nursing Research ❖ September 2007 ❖ Vol 1 ❖ No 2 contributed to the positive results of this interven- REFERENCES
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