scholarly journals 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

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040637
Author(s):  
Ilse Reinders ◽  
Hanneke A H Wijnhoven ◽  
Satu K Jyväkorpi ◽  
Merja H Suominen ◽  
Riikka Niskanen ◽  
...  

IntroductionShort-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 analysisThe 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.DiscussionThe 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 disseminationThe 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 numberClinicalTrials.gov Registry (NCT03712306).

2019 ◽  
Vol 8 ◽  
Author(s):  
Jos W. Borkent ◽  
Janne Beelen ◽  
Joost O. Linschooten ◽  
Annet J. C. Roodenburg ◽  
Marian A. E. de van der Schueren

AbstractThe risk of undernutrition in older community-dwelling adults increases when they are no longer able to shop or cook themselves. Home-delivered products could then possibly prevent them from becoming undernourished. This single-blind randomised trial tested the effectiveness of home-delivered protein-rich ready-made meals and dairy products in reaching the recommended intake of 1·2 g protein/kg body weight (BW) per d and ≥25 g of protein per meal. Community-dwelling older adults (n 98; mean age 80·4 (sd 6·8) years) switched from self-prepared to home-delivered hot meals and dairy products for 28 d. The intervention group received ready-made meals and dairy products high in protein; the control group received products lower in protein. Dietary intake was measured at baseline, after 2 weeks (T1), and after 4 weeks (T2). Multilevel analyses (providing one combined outcome for T1 and T2) and logistic regressions were performed. Average baseline protein intake was 1·09 (se 0·05) g protein/kg BW per d in the intervention group and 0·99 (se 0·05) g protein/kg BW per d in the control group. During the trial, protein intake of the intervention group was 1·12 (se 0·05) g protein/kg BW per d compared with 0·87 (se 0·03) g protein/kg BW per d in the control group (between-group differences P &lt; 0·05). More participants of the intervention group reached the threshold of ≥25 g protein at dinner compared with the control group (intervention T1: 84·8 %, T2: 88·4 % v. control T1: 42·9 %, T2: 40·5 %; P &lt; 0·05), but not at breakfast and lunch. Our findings suggest that switching from self-prepared meals to ready-made meals carries the risk of a decreasing protein intake, unless extra attention is given to protein-rich choices.


2018 ◽  
Vol 33 (3) ◽  
pp. 439-449 ◽  
Author(s):  
Chandra da Silveira Langoni ◽  
Thais de Lima Resende ◽  
Andressa Bombardi Barcellos ◽  
Betina Cecchele ◽  
Juliana Nunes da Rosa ◽  
...  

Objective: To determine the effects of group exercises on balance, mobility, and depressive symptoms in community-dwelling older adults with mild cognitive impairment. Design: Single blinded, randomized, matched pairs clinical trial. Setting: Four primary healthcare units. Subjects: Fifty-two sedentary subjects with mild cognitive impairment were paired (age, sex, body mass index, and Addenbrooke’s Cognitive Examination Revised score), tested, and then randomized into an intervention group ( n = 26) and a control group ( n = 26). Intervention: The intervention group performed strength (ankle weights, elastic bands, and dumbbells) and aerobic exercises (walking) in their communities’ public spaces, twice a week (60 minutes each), during 24 weeks. The control group maintained its usual routine. Main measures: Balance (Berg Balance Scale (BBS)), mobility (Timed Up and Go Test (TUG)), and depressive symptoms (Geriatric Depression Scale-15) were assessed before and after the intervention. Results: Before the intervention, the two groups did not differ statistically. After, the intervention group showed significant improvement ( P < 0.05) in balance (before: 53 ± 3; after: 55.1 ± 1.1 points), mobility (before: 10.7 ± 2.9 seconds; after: 8.3 ± 2 seconds), and depressive symptoms (median punctuation (interquartile range) before: 4 (1.8–6); after: 2.5 (1–4)). The control group presented a significant increase in their depressive symptoms (median before: 3.5 (2–7.3); after: 4 (2–5.3)), while their balance and mobility showed no significant modification. Small effect sizes were observed in the intervention group and control group depressive symptoms, as well as in the control group’s mobility and balance. Large effect sizes were observed the intervention group’s mobility and balance. Conclusion: Group exercises improved balance, mobility, and depressive symptoms in community-dwelling older adults with mild cognitive impairment.


2019 ◽  
Vol 48 (Supplement_4) ◽  
pp. iv18-iv27
Author(s):  
Sasiporn Ounjaichon ◽  
Chris Todd ◽  
Emma Stanmore ◽  
Elisabeth Boulton

Abstract Introduction Falls are the leading cause of injuries in older Thai adults. There is a need to develop a fall prevention exercise programme to encourage participation and adherence. The adapted Lifestyle-integrated Functional Exercise (aLiFE) programme may be suitable by integrating exercise into daily routines as opposed to attending an exercise class. This study aimed to explore the acceptability and feasibility of the aLiFE programme in Thai context (TLiFE) among older Thai adults. Methods Based on the findings of a prior qualitative study, a feasibility randomised controlled trial (RCT) of TLiFE was conducted among community-dwelling older adults, comparing the TLiFE intervention group with a usual care control group. Outcome measures were analysed at baseline, 3 months, and after 6 months of the intervention. Results We recruited a total of 72 older adults into the RCT, randomised to TLiFE (n=36) and control (n=36). The retention rate at 6 months was 91.7%. Attendance in the intervention group (3 home visits and 4 follow-up calls) was 82.9%. There were no differences in fall incidence between the groups. The acceptability survey reveals TLiFE is easy to perform in daily life, safe, and useful. No adverse events were reported. Conclusion The TLiFE programme appears to be acceptable and feasible to deliver to community-dwelling older Thai adults. This feasibility study was not powered to detect a difference between groups. A further fully powered definitive randomised controlled trial of TLiFE is needed to evaluate long-term outcomes and cost-effectiveness before it is integrated within the healthcare system in Thailand.


2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S169-S169
Author(s):  
Junxin Li ◽  
Sarah Szanton ◽  
Minhui Liu ◽  
Nada Lukkahatai ◽  
Junxin Li ◽  
...  

Abstract Evidence suggests physical activity (PA) improves sleep in older adults. This study examined the preliminary effect of a personalized mHealth behavioral intervention on PA and sleep in older adults. We conducted a randomized controlled pilot trial in 21 community-dwelling older adults with sleep complaints. The 24-week mHealth behavioral intervention included a 2-hour in person training session, personalized exercise prescription, real time PA self-monitoring, interactive prompts, phone consultation, and weekly financial incentives. PA and sleep were measured objectively using Actiwatch 2.0 and subjectively using questionnaires. Peripheral blood was drawn for measuring Plasma inflammatory biomarkers [interleukin 1β, 6, 8, Tumor Necrosis Factor- alpha (TNF-α), and c-reactive protein (CRP)]. Data were collected at baseline, 8-week, 16-week, and post intervention. Repeated measures ANOVA (time*group) was used to examine differences of PA and sleep across times between the two groups. Majority of participants are women (71.4%) with mean age of 73.7 (SD = 6.9). Repeated measure ANOVA showed significant (p &lt;0.05) improvement of objective and subjective PA, objective nocturnal sleep duration, self-report sleep quality (measured by Pittsburg Sleep Quality Index and Insomnia Severity Index) and decreasing of sedentary time over times in the intervention group (n=11), compared to the control group. The intervention group showed significant reduction of plasma TNF-α and CRP levels at 16-week and post intervention. Interventions combining personalized PA and mHealth strategies may positively affect physical activity and sleep in older adults. A larger study is needed to test the efficacy of this intervention and the mechanisms associated with it.


Author(s):  
Junxin Li ◽  
Sarah L. Szanton ◽  
Miranda V. McPhillips ◽  
Nada Lukkahatai ◽  
Grace W. Pien ◽  
...  

This randomized controlled pilot trial tested the preliminary effect of a 24-week mHealth-facilitated, personalized intervention on physical activity (PA) and sleep in 21 community-dwelling older adults. The intervention included a personalized exercise prescription, training, goal setting, and financial incentives. mHealth strategies, including self-monitoring, motivational messages, activity reminders, and phone coaching, were used to facilitate PA participation. PA and sleep were measured using actigraphy and questionnaires at baseline and 8-, 16-, and 24-week visits. Participants in the intervention group had lower objective PA levels at 24 weeks than at 8 and 16 weeks, although levels of PA remained higher than at baseline. Compared with the control group, the intervention increased PA at 8, 16, and 24 weeks; improved subjective sleep quality at 16 and 24 weeks; and increased actigraphy-measured sleep duration and sleep efficiency at 24 weeks. mHealth PA interventions may benefit PA and sleep in older adults. Strategies for maintaining long-term PA behavioral changes are needed.


2020 ◽  
Vol 49 (6) ◽  
pp. 1011-1019 ◽  
Author(s):  
Chi Hsien Huang ◽  
Hiroyuki Umegaki ◽  
Taeko Makino ◽  
Kazuki Uemura ◽  
Takahiro Hayashi ◽  
...  

Abstract Background Physical exercise has been linked to reduced frailty, but there is insufficient evidence of beneficial effects in community-dwelling older adults with subjective cognitive concerns. Objective This study aimed to clarify the effects of physical exercise in this population. Design Single-blind randomised controlled trial. Setting Community sports centres. Participants Residents aged 65–85 years were screened using the Kihon checklist; those with subjective cognitive concerns were invited for eligibility assessment. In total, 415 community-dwelling older adults were enrolled and randomised. Methods This trial investigated the effects of aerobic training (AT), resistance training (RT) and combined training (AT+RT) programs on reducing frailty. All participants were randomised into one of the three intervention groups or the control group. Participants in the intervention groups underwent a group training program and self-paced home training for 26 weeks. The control group received lectures about health promotion. A 95-item frailty index (FI) was utilised to determine the effects of training. Participants were followed up at weeks 26 and 52. Results At baseline, mean age of all participants (47% women) was 72.3 ± 4.6 years, with a mean FI score of 0.3 ± 0.1. Compared with control group, AT improved total FI by 0.020 (CI −0.039 to −0.001, effect size −0.275) and the depression and anxiety component of FI by 0.051 (CI −0.084 to −0.018, effect size −0.469) at week 26, but the effects waned at week 52. No significant differences in FI were found in RT and AT+RT groups at weeks 26 and 52. Conclusions A 26-week AT reduced frailty modestly, especially in the depression and anxiety component, in older adults with subjective cognitive concerns.


2020 ◽  
pp. 1-14
Author(s):  
E van den Heuvel ◽  
JL Murphy ◽  
KM Appleton

Abstract Objective: This study investigated the impact of recipe and single-use herb/spice packet provision on egg intake and protein intake in community-dwelling individuals aged over 55 years. Design: Using a randomised-controlled intervention design, 100 older adults were randomised to receive (n 53) or not receive (n 47) high-protein egg-based recipes and herb/spice packets through the post for 12 weeks, from June to December 2016. Egg intake, protein intake, adverse events, lean body mass and functional measures of lean body mass were measured at baseline, after the 12 weeks and after a further 12 weeks. Setting: Bournemouth, UK. Participants: Community-dwelling older adults. Results: Intention-to-treat data were analysed using regression, controlling for various demographic and lifestyle characteristics. Ninety-three individuals (intervention, n 50; control, n 43) completed assessments at all three time points. Egg intakes increased by end of intervention in both groups (mean: 4–5 eggs/month). After a further 12 weeks, higher egg intakes were sustained in the intervention group, while egg intakes in the control group returned to baseline levels (between-group difference: β = −0·124, P = 0·047). No differences were found in other measures (largest β = −0·106, P = 0·12). Conclusions: The provision of high-protein egg-based recipes and single-use herb/spice packets over 12 weeks increased egg intakes up to 12 weeks after end of intervention. Other factors may explain increased egg intakes during the intervention, but the sustained effects most plausibly result directly from recipe provision. Limited effects in other measures suggest that the recipes may have replaced as opposed to added to existing protein intakes.


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