I. NYKANEN 1,2, T.H. RISSANEN 3, R. SULKAVA 4,5, S. HARTIKAINEN 1,2. Methods

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1 13 NYKANEN_04 LORD_c 05/03/14 10:09 Page54 EFFECTS OF INDIVIDUAL DIETARY COUNSELING AS PART OF A COMPREHENSIVE GERIATRIC ASSESSMENT (CGA) ON NUTRITIONAL STATUS: A POPULATION-BASED INTERVENTION STUDY I. NYKANEN 1,2, T.H. RISSANEN 3, R. SULKAVA 4,5, S. HARTIKAINEN 1,2 1. Kuopio Research Centre of Geriatric Care, University of Eastern Finland, Kuopio, Finland; 2. School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland; 3. Institute of Public Health and Clinical Nutrition, Unit of Public Health, University of Eastern Finland, Kuopio, Finland; 4. Institute of Public Health and Clinical Nutrition, Unit of Geriatrics, University of Eastern Finland, Kuopio, Finland; 5. Department of Neurology, Kuopio University Hospital, Kuopio, Finland. Corresponding author: Irma Nykänen, Address Kuopio Research Centre of Geriatric Care, Faculty of Health Sciences, University of Eastern Finland, Kuopio Campus, P.O.BOX 1627, FI Kuopio, Finland, Phone: , Fax: , Irma.Nykanen@uef.fi Abstract: Background: Nutritional risk is relatively common in community-dwelling older people. Objective: To objective of this study was to evaluate the effects of individual dietary counseling as part of a Comprehensive Geriatric Assessment on nutritional status among community-dwelling people aged 75 years or older. Methods: Data were obtained from a subpopulation of participants in the population-based Geriatric Multidisciplinary Strategy for the Good Care of the Elderly (GeMS) intervention study in 2004 to In the present study, the population consist 173 persons at risk of malnutrition in the year 2005 in an intervention (n=84) and control group (n=89). Nutritional status, body weight, body mass index, serum albumin were performed at the beginning of the study and at a two-year follow-up. The nutritional screening was performed using the Mini Nutritional Assessment (MNA) test. Results: A increase in MNA scores (1.8 95% confidence interval [CI]: 0.7 to 2.0) and in serum albumin (0.8 g/l, 95% CI: 0.2 to 0.9 g/l) were a significant difference between the groups. Conclusions: Nutritional intervention, even dietary counseling without nutritional supplements, may improve nutritional status. Key words: Dietary counselling, nutrition intervention, MNA, aging. Introduction Nutritional health is essential for overall health, independence and quality of life in older people (1 3). The physiological (4 6), psychological (7) and social changes (8) associated with ageing that affect food and nutritional intake and body weight. This means that older people are at increased risk of malnutrition. The risk of malnutrition is common among community-dwelling older people, ranging between 5 and 40% (9). In Finland among community-dwelling people aged 75 and over, the prevalence of possible malnutrition was 15% as measured with the MNA-SF (10). Dietary advice may often be required at this stage and should be available to individuals living at home. Most intervention studies aimed at improving nutritional status among the elderly have been examining the effects of dietary supplements in addition to regular meals (11, 12). In addition, most of these studies have been conducted in hospitals or in nursing homes. However, the vast majority of older people are community-dwelling, and the promotion of their nutritional health might prevent adverse health outcomes, such as institutionalization. As far as we know, there are no previous nutritional intervention studies spanning two years among community-dwelling older people. The aim of the present study is to evaluate the effects of individual dietary counseling as part of a Comprehensive Geriatric Assessment (CGA) on nutritional status among community-dwelling people aged 75 years or older. Received November 14, 2012 Accepted for publication March 8, Methods Study Sample This study is based on a subpopulation of participants in the population-based Geriatric Multidisciplinary Strategy for the Good Care of the Elderly (GeMS) intervention aimed at preventing disability and maintaining autonomy in older people (10). Figure 1 shows the flow of participants through the study. The intervention group underwent a Comprehensive Geriatric Assessment (CGA) at the baseline and yearly from 2006 and The intervention of the parent GeMS study focused on optimizing medical treatment and medication and improving and preventing decline in nutrition and function. The CGA was performed by a team consisting of two physicians, two study nurses, one nutritionist and two physiotherapists. The control group was interviewed and tested annually and they received normal medical care. The population of this study comprised persons who were at risk of malnutrition (MNA scores 17.0 to 23.5). After two years, the dropout rate was 20% (35/173) of the participants at the baseline. All participants or their proxies gave written informed consent to participate in the study. The study protocol was approved by the Research Ethics Committee of the Northern Savo Hospital District, Kuopio, Finland. Data collection All participants were interviewed and examined yearly by three nurses. Data collection, including nutritional assessment, was supplemented by a caregiver interview if the participant had cognitive impairment.

2 13 NYKANEN_04 LORD_c 05/03/14 10:09 Page55 JNHA: CLINICAL TRIALS AND AGING Outcome variables The nutritional screening was performed using the MNA test (13). The MNA test is a validated and standardized screening tool developed to detect nutritional problems in older people. In this study, the researcher (an authorized nutritionist) trained nurses to use the MNA form, and the nurses completed the forms. The plasma albumin levels were measured according to the standard protocols at the local municipal hospital. Background variables Self-rated health was determined using a 5-point scale (1=very good, 2=good, 3=moderate, 4=poor and 5=very poor). In the analyses, the variable was dichotomized into good and poor self-rated health, with the first three steps representing good and the latter two poor self-rated health. Oral health assessment included questions about dry mouth and chewing problems. In the analyses, these were dichotomized into two groups 1. persons with dry mouth or problems with chewing and 2. persons not having dry mouth, no problems with chewing. Use of medications was self-reported by participants during the interviews, and verified from prescription forms, drug packages and medical records. Data on medication name, frequency, and pattern of use (regular, when required) were recorded. Performance in the IADL was assessed by the 8-item Lowton and Brody scale (14). The scoring for the IADL index is from 0-8, with higher scores indicating better functioning. Cognitive assessment was performed with the Mini-Mental State Examination (MMSE) with scale from 0-30, higher scores indicating better function. Comorbidity was computed using a modified version of the Functional Comorbidity Index (FCI) (15). The original FCI is a validated scale that predicts physical function in older people. The modified version, suitable for older population, is described in the previous study (16). Nutritional intervention Nutritional intervention included an individually tailored comprehensive geriatric intervention in which the other components were medical and physical intervention. In the medical intervention, the main focus was on the optimization of care and medication, and on the management of major medical problems commonly encountered in old age (17). In the physical activity component, the participants were offered an opportunity to participate the individually tailored physical activity counseling by physiotherapist and in strength and balance training once a week where one of the main objectives was to prevent mobility disability, the emphasis of strength training was the lower extremities (18). The participants of control group did not receive any interventions but took part in the annual interviews and measurements and used normal health care services. The tailored nutritional treatment consisted of individual dietary counseling based on baseline MNA-test. The individual dietary counseling was based on the recommendations of the National Nutrition Council (19). The individualized treatment strategy for each participant was designed by the nutritionist according to the participant s medical and nutritional characteristics. The main aim of the intervention was to help participants improve the wholesomeness of their diet in line with Finnish recommendations by increasing the frequency of meals and/or adding energy (if necessary) and proteins to the meals without nutritional supplements. Each participant had two nutritional treatment meetings with the nutritionist, the first in 2005, the second in During the first visit, the authorized nutritionist collected important information, such as the client s history of health problems, current dietary intake and specific nutritional problems, food preferences and appetite status. Based on this evaluation, the nutritionist helped the participants draw up their own meal plan with enough energy and proteins. Special leaflets covering, for example, snacking, were handed out. Telephone call between the visits, as deemed necessary by the nutritionist, provided opportunities to reinforce the dietary advice and give additional support. All participants received telephone counseling ones every two months during the intervention. Participants family members were encouraged to attend dietary counseling sessions. Participants with cognitive impairments had a caregiver present during the sessions; written informed consent was provided by participants and caregivers. During the second visit, the nutritionist evaluated the dietary intake of the participants and made changes according to the treatment protocol, if necessary. At the same time, participants as well as family members and caregivers received instructions on how to follow the recommended diet. Statistical Analysis Power calculation showed that 65 subjects were needed in both groups to detect a difference in order to achieve the statistical power of 0.80 with an alpha of The participants were categorized into two groups, the intervention and the control group. Statistical comparisons were made between the groups at baseline using chi-square test or t- test, with 0.05 considered significant. The results were expressed as means or frequencies with standard deviations (SD) or percentile. The Mixed Model of linear regression was used to assess the effects of the nutrition between the years 2005 and The results were reported as adjusted (age, gender, IADL, MMSE and FCI sum score) mean differences in MNA scores, body weight, BMI and serum albumin. Analyses were performed using SPSS version (SPSS, Inc., Chicago, IL). Results Table 1 provides key characteristics of the two groups. At the baseline, there were no differences between the intervention group and the control group regarding demographic 55

3 13 NYKANEN_04 LORD_c 05/03/14 10:09 Page56 EFFECTS OF DIETARY COUNSELING ON NUTRITION characteristics, functional co-morbidity index, and clinical characteristics or functioning. In the intervention group, 77.5% were women, compared to 78.2% in the control group. The mean age was 82.9 in the intervention group and 82.5 in the control group. Table 1 Baseline characteristics of participants Control Intervention P value group group (n = 89) (n = 84) Demographic characteristics Age, year, mean (SD)* 82.5 (4.9) 82.9 (4.9) 0.88 Female, n (%) 64 (78.2) 55 (77.5) 0.86 Living alone, n (%) 50 (68.5) 41 (60.3) 0.31 Education, 7 years n (%) 41 (51.5) 29 (40.8) 0.09 Clinical characteristics MNA scores, mean (SD) 21.6 (1.4) 21.6 (1.9) 0.91 BMI kg/m2, mean (SD) 26.1 (3.8) 25.9 (5.2) 0.71 Serum albumin g/l, mean (SD) 35.7 (4.0) 35.8 (4.5) 0.83 Good self-rated health, n (%) 84 (78.5) 65 (77.4) 0.88 Dry mouth/chewing problems, n (%) 25 (23.4) 17 (20.2) 0.65 Drugs in regular use, mean (SD) 6.0 (3.2) 6.8 (3.5) 0.66 IADL scores, mean (SD) 4.8 (2.3) 5.0 (2.7) 0.56 MMSE 24, n (%) 48 (53.9) 37 (44.0) 0.16 Functional comorbidity index, mean (SD) 3.4 (1.9) 3.5 (2.0) 0.64 Gardiovascular disease, n (%) 84 (78.5) 65 (77.4) 0.88 Dementia, n (%) 21 (23.6) 19 (22.6) 0.87 nutritional status. Mean difference in serum albumin level (0.8 g/l, 95% CI: 0.2 to 0.9 g/l) was also significant between the groups. Serum albumin increased 0.9 g/l from baseline to follow-up in the intervention group, but remained unchanged in the control group. The mean differences in body weight and BMI were not significant between the groups. However, the percentage of participants with dementia who had a BMI less than 23 increased more in the control group than in the intervention group. The change was not statistically significant. Figure 1 Flow-chart of the study SD = Standard Deviation, MNA = Mini Nutritional Assessment, BMI = Body Mass Index (kg/m2); IADL = Instrumental Activities of Daily Living; MMSE = Mini-Mental State Examination Table 2 Changes in nutritional status from baseline to 2-years and differences between intervention and control groups at 2-years Mean change Mean change Mean difference 2005 to to 2007 between groups* (95% CI) (95% CI) (95% CI) Control group Intervention group (n=89) (n=84) MNA, scores -1.0 (-1.8 to -0.3) 0.8 (0.3 to 1.5) 1.8 (0.7 to 2.0) Body weight, kg -0.9 (-1.8 to -0.6) 0.2 (-0.1 to 0.7) 1.1 (-0.3 to 1.7) BMI, kg/m2-0.4 (-1.5 to 0.5) 0.2 (-0.4 to 0.1) 0.7 (-1.2 to 2.5) Serum albumin (g/l) 0.0 (-0.6 to 0.6) 0.9 (0.3 to 1.3) 0.8 (0.2 to 0.9) Note: MNA = Mini Nutritional Assessment, BMI = Body Mass Index (kg/m2), IADL = Instrumental Activities of Daily Living, MMSE = Mini-Mental State Examination; *Adjusted for age, gender, IADL, MMSE and FCI sum score Table 2 shows 2-year measurements of the primary outcomes changes and the adjusted differences between the two groups. At the two-year follow-up, the mean MNA scores increased 0.8 in the intervention group and decreased 1.0 in the control group. The difference in MNA between the two groups (1.8 95% confidence intervals [CI]: 0.7 to 2.0) at the end of the 2-year intervention after adjustment for age, gender, IADL, MMSE and FCI sum score was significant. In subanalyses concern subscore of MNA the best improvement was as a number of meals, protein food intake and self-perception of Discussion This study revealed that a nutritional intervention consisting of individual dietary counseling without supplements may lead to an improvement in the nutritional status among homedwelling older people. To our knowledge, this is the first long-term study to evaluate the effects of dietary counseling on nutritional status among home-dwelling older people in the long term. In earlier studies, follow-up times have ranged from 3 to 18 months and focused on specific diseases (20 23), whereas in our study the follow-up period was two years and focused on healthy home-dwelling participants. The results showed that MNA and serum albumin increased in our study. Only one recent study (21) has reported that dietary counseling without supplements was effective in raising albumin levels in patients aged 71 years suffering from chronic kidney disease. Most studies have reported using factory-produced protein and energy 56

4 13 NYKANEN_04 LORD_c 05/03/14 10:09 Page57 JNHA: CLINICAL TRIALS AND AGING supplementation improving the nutritional status (12). In present study, the participants reported increases both number of meals and protein food intake without nutrition supplements. Lorefält and Wilhelmsson (24) have also shown that it is possible to improve nutritional status by improving conventional food. In our study, body weight decreased in the control group (0.9 kg, 0.6 to 1.8 kg) while weight change in the intervention group was not statistically significant. The positive effects of dietary couseling without nutritional supplements on weight have been shown. The Berstein (25) home-based nutrition intervention study showed an increase in weight during six months. Similar kinds of positive effects of dietary counseling without nutritional supplements on weight have been shown among older people in the one study of people at risk of osteoporotic fracture with a follow-up of four months (26). Furthermore, nutritional intervention programmes have been effective in preventing weight loss in Alzheimer s disease (27,28). In our study, dietary counseling slowed down weight loss in participants with dementia, but the difference between the groups was not significant. Evidence is still limited regarding the effectiveness of dietary counseling in managing malnutrition among home-dwelling older people. Protein energy malnutrition occurs either due to reduced dietary intake or as a consequence of disease, both of which result in loss of body weight. Food fortification is achieved through the addition of energy- and protein-rich food. Oral nutritional supplements can also be provided. The positive effect on nutritional status might be explained by the individually tailored interventions among persons who are at risk of malnutrition. The beneficial effect of intervention among these persons is important from a public health standpoint, as risk of malnutrition and even malnutrition is common among community-dwelling older people and when left undertreated, causes many difficulties in older people. The vast majority of older people live in their own homes. Functionally dependent community-dwelling older people are at an increased risk of developing malnutrition. The challenge is to identify those who are at risk of malnutrition so that targeted individual interventions can be carried out. This is important as adequate nutrition helps older people to maintain their activities of daily living and thus preserve functional autonomy so they can enjoy longer and healthier lives in their own homes (29). Nutritional interventions need to reflect different energy needs better and include the provision of nutrient-dense food. Many age-related nutritional problems may be remedied to some extent by providing nutrient-dense meals through home delivery or meal congregate programmes. More studies that integrate nutritional intervention are needed to determine the impact of diet on nutrition, health and overall quality of life. The process by which diet acts as an intermediary between experience of health and illness, disease and disability in the older population is complex and multifactorial, making the design of studies in community-dwelling particularly challenging. The strengths of the present study were the population-based design, the fact that participants underwent comprehensive interviews and assessments, as well as the fact that the study design and data collection was conducted by a multiprofessional research team. The nutrition intervention included individually tailored personal guidance on nutrition, so it may be assumed that dietary counseling was more likely to be adopted by the participants. Furthermore, the nutrition intervention was performed by the same authorized nutritionist. The study has some limitations. The design of the study is weaker than a traditional randomized controlled trial, owing to randomization having been performed before the baseline measurements. Nutrition represents only one element of a complex array of interactions that may affect participants outcomes. Our study on nutritional intervention is one of many health promotion interventions, and this can lead to difficulties in drawing conclusions. Some evidence suggests that a nutritional intervention, such as dietary counseling alone without supplement, can influence diet and physical function, but we were unable to determine whether the changes seen here were attributable to the nutrition intervention or to other interventions. 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