The cost effectiveness of personalized dietary advice to increase protein intake in older adults with lower habitual protein intake: a randomized controlled trial.

PURPOSE: To examine the cost effectiveness of dietary advice to increase protein intake on 6-month change in physical functioning among older adults. METHODS: In this multicenter randomized controlled trial, 276 community-dwelling older adults with a habitual protein intake < 1.0 g/kg adjusted body weight (aBW)/d were randomly assigned to either Intervention 1; advice to increase protein intake to ≥ 1.2 g/kg aBW/d (PROT, n = 96), Intervention 2; similar advice and in addition advice to consume protein (en)rich(ed) foods within half an hour after usual physical activity (PROT + TIMING, n = 89), or continue the habitual diet with no advice (CON, n = 91). Primary outcome was 6-month change in 400-m walk time. Secondary outcomes were 6-month change in physical performance, leg extension strength, grip strength, body composition, self-reported mobility limitations and quality of life. We evaluated cost effectiveness from a societal perspective. RESULTS: Compared to CON, a positive effect on walk time was observed for PROT; - 12.4 s (95%CI, - 21.8 to - 2.9), and for PROT + TIMING; - 4.9 s (95%CI, - 14.5 to 4.7). Leg extension strength significantly increased in PROT (+ 32.6 N (95%CI, 10.6-54.5)) and PROT + TIMING (+ 24.3 N (95%CI, 0.2-48.5)) compared to CON. No significant intervention effects were observed for the other secondary outcomes. From a societal perspective, PROT was cost effective compared to CON. CONCLUSION: Dietary advice to increase protein intake to ≥ 1.2 g/kg aBW/d improved 400-m walk time and leg strength among older adults with a lower habitual protein intake. From a societal perspective, PROT was considered cost-effective compared to CON. These findings support the need for re-evaluating the protein RDA of 0.8 g/kg BW/d for older adults. TRIAL REGISTRATION: The trial has been registered at ClinicalTrials.gov (NCT03712306). Date of registration: October 2018. Registry name: The (Cost) Effectiveness of Increasing Protein Intake on Physical Functioning in Older Adults. Trial Identifier: NCT03712306.

Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trial.

INTRODUCTION: Short-term metabolic and observational studies suggest that protein intake above the recommended dietary allowance of 0.83 g/kg body weight (BW)/day may support preservation of lean body mass and physical function in old age, but evidence from randomised controlled trials is inconclusive. METHODS AND ANALYSIS: The PRevention Of Malnutrition In Senior Subjects in the EU (PROMISS) trial examines the effect of personalised dietary advice aiming at increasing protein intake with or without advice regarding timing of protein intake to close proximity of usual physical activity, on change in physical functioning after 6 months among community-dwelling older adults (≥65 years) with a habitual protein intake of <1.0 g/kg adjusted (a)BW/day. Participants (n=264) will be recruited in Finland and the Netherlands, and will be randomised into three groups; two intervention groups and one control group. Intervention group 1 (n=88) receives personalised dietary advice and protein-enriched food products in order to increase their protein intake to at least 1.2 g/kg aBW/day. Intervention group 2 (n=88) receives the same advice as described for intervention group 1, and in addition advice to consume 7.5-10 g protein through protein-(en)rich(ed) foods within half an hour after performing usual physical activity. The control group (n=88) receives no intervention. All participants will be invited to attend lectures not related to health. The primary outcome is a 6-month change in physical functioning measured by change in walk time using a 400 m walk test. Secondary outcomes are: 6-month change in the Short Physical Performance Battery score, muscle strength, body composition, self-reported mobility limitations, quality of life, incidence of frailty, incidence of sarcopenia risk and incidence of malnutrition. We also investigate cost-effectiveness by change in healthcare costs. DISCUSSION: The PROMISS trial will provide evidence whether increasing protein intake, and additionally optimising the timing of protein intake, has a positive effect on the course of physical functioning after 6 months among community-dwelling older adults with a habitual protein intake of <1.0 g/kg aBW/day. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of the Helsinki University Central Hospital, Finland (ID of the approval: HUS/1530/2018) and The Medical Ethical Committee of the Amsterdam UMC, location VUmc, Amsterdam, the Netherlands (ID of the approval: 2018.399). All participants provided written informed consent prior to being enrolled onto the study. Results will be submitted for publication in peer-reviewed journals and will be made available to stakeholders (ie, older adults, healthcare professionals and industry). TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03712306).

Targeting the underlying causes of undernutrition. Cost-effectiveness of a multifactorial personalized intervention in community-dwelling older adults: A randomized controlled trial.

BACKGROUND & AIMS: Undernutrition in old age is associated with increased morbidity, mortality and health care costs. Treatment by caloric supplementation results in weight gain, but compliance is poor in the long run. Few studies targeted underlying causes of undernutrition in community-dwelling older adults. This study aimed to evaluate the cost-effectiveness of a multifactorial personalized intervention focused on eliminating or managing the underlying causes of undernutrition to prevent and reduce undernutrition in comparison with usual care. METHODS: A randomized controlled trial was performed among 155 community-dwelling older adults receiving home care with or at risk of undernutrition. The intervention included a personalized action plan and 6 months support. The control group received usual care. Body weight, and secondary outcomes were measured in both groups at baseline and 6 months follow-up. Multiple imputation, linear regression and generalized estimating equation analyses were used to analyze intervention effects. In the cost-effectiveness analyses regression models were bootstrapped to estimate statistical uncertainty. RESULTS: This intervention showed no statistically significant effects on body weight, mid-upper arm circumference, grip strength, gait speed and 12-Item Short-Form Health Survey physical component scale as compared to usual care, but there was an effect on the 12-Item Short-Form Health Survey mental component scale (0-100) (ß = 8.940, p=0.001). Borderline significant intervention effects were found for both objective and subjective physical function measures, Short Physical Performance Battery (0-12) (ß = 0.56, p=0.08) and ADL-Barthel score (0-20) (ß = 0.69, p=0.09). Societal costs in the intervention group were statistically non-significantly lower than in the control group (mean difference -274; 95% CI -1111; 782). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was 0.72 at a willingness-to-pay of 1000 €/kg weight gain and 0.80 at a willingness-to-pay of 20,000 €/quality-adjusted life year gained. CONCLUSIONS: This multifactorial personalized intervention showed a statistically non-significant effect and was not cost-effective on body-weight compared to usual care. We observed consistently beneficial treatment effects in the intervention group on all outcomes measures. CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE: NTR5184 (www.trialregister.nl).

Factors associated with (risk of) undernutrition in community-dwelling older adults receiving home care: a cross-sectional study in the Netherlands.

OBJECTIVE: It is generally thought that causes of undernutrition are multifactorial, but there are limited quantitative studies performed. We therefore examined a wide range of potential factors associated with undernutrition in community-dwelling older adults. DESIGN: Cross-sectional study. SETTING: Community-dwelling older adults (≥65 years) receiving home care in the Netherlands. SUBJECTS: Data on potential factors associated with (risk of) undernutrition were collected among 300 older adults. Nutritional status was assessed by the SNAQ65+ instrument. Undernutrition was defined as mid-upper arm circumference <25 cm or unintentional weight loss of ≥4 kg in 6 months. Being at risk of undernutrition was defined as having poor appetite and inability to walk up and down stairs of fifteen steps, without resting. RESULTS: Of all participants, ninety-two (31·7 %) were undernourished and twenty-four (8·0 %) were at risk of undernutrition. Based on multivariate logistic regression analyses, the statistically significant factors associated with (risk of) undernutrition (P<0·05) were: unable to go outside (OR=5·39), intestinal problems (OR=2·88), smoking (OR=2·56), osteoporosis (OR=2·46), eating fewer than three snacks daily (OR=2·61), dependency in activities of daily living (OR=1·21), physical inactivity (OR=2·01), nausea (OR=2·50) and cancer (OR=2·84); a borderline significant factor was depression symptoms (OR=1·83, P=0·053). CONCLUSIONS: The study suggests that (risk of) undernutrition is a multifactorial problem and that associated factors can be found in several domains. These findings may support the development of intervention trials for the prevention and treatment of undernutrition in community-dwelling older adults.

Determinants of protein-energy malnutrition in community-dwelling older adults: a systematic review of observational studies.

Protein-energy malnutrition is associated with numerous poor health outcomes, including high health care costs, mortality rates and poor physical functioning in older adults. This systematic literature review aims to identify and provide an evidence based overview of potential determinants of protein-energy malnutrition in community-dwelling older adults. A systematic search was conducted in PUBMED, EMBASE, CINAHL and COCHRANE from the earliest possible date through January 2013. Observational studies that examined determinants of protein-energy malnutrition were selected and a best evidence synthesis was performed to summarize the results. In total 28 studies were included in this review from which 122 unique potential determinants were derived. Thirty-seven determinants were examined in sufficient number of studies and were included in a best evidence synthesis. The best evidence score comprised design (cross-sectional, longitudinal) and quality of the study (high, moderate) to grade the evidence level. Strong evidence for an association with protein-energy malnutrition was found for poor appetite, and moderate evidence for edentulousness, having no diabetes, hospitalization and poor self-reported health. Strong evidence for no association was found for anxiety, chewing difficulty, few friends, living alone, feeling lonely, death of spouse, high number of diseases, heart failure and coronary failure, stroke (CVA) and the use of anti-inflammatory medications. This review shows that protein-energy malnutrition is a multifactorial problem and that different domains likely play a role in the pathway of developing protein-energy malnutrition. These results provide important knowledge for the development of targeted, multifactorial interventions that aim to prevent the development of protein-energy malnutrition in community-dwelling older adults.