A preventative lifestyle intervention for older adults (lifestyle matters): a randomised controlled trial.
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SUBMITTER: Mountain G
PROVIDER: S-EPMC5860501 | biostudies-other | 2017 Jul
REPOSITORIES: biostudies-other
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A preventative lifestyle intervention for older adults (lifestyle matters): a randomised controlled trial.
Mountain Gail G Windle Gill G Hind Daniel D Walters Stephen S Keertharuth Anju A Chatters Robin R Sprange Kirsty K Craig Claire C Cook Sarah S Lee Ellen E Chater Tim T Woods R R Newbould Louise L Powell Lauren L Shortland Katy K Roberts Jennifer J
Age and ageing 20170701 4
<h4>Objectives</h4>to test whether an occupation-based lifestyle intervention can sustain and improve the mental well-being of adults aged 65 years or over compared to usual care, using an individually randomised controlled trial.<h4>Participants</h4>288 independently living adults aged 65 years or over, with normal cognition, were recruited from two UK sites between December 2011 and November 2015.<h4>Interventions</h4>lifestyle Matters is a National Institute for Health and Care Excellence rec ...[more]
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Project description:Objectives Robust research of complex interventions designed to promote mental well-being in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a detailed description of the design and implementation of a fidelity assessment within a trial of one such intervention (Lifestyle Matters). The findings help to explain the trial results and also inform the design of embedded fidelity assessments within future evaluations of complex interventions. Design We conducted a mixed-method fidelity assessment embedded as part of a multicentre pragmatic randomised controlled trial. A conceptual fidelity framework was developed from the Behaviour Change Consortium framework. From this the fidelity assessment was designed. The resulting instrument assessed the following parameters: intervention design, training, supervision; and delivery, receipt and enactment of the intervention. Intervention The Lifestyle Matters intervention was designed to assist older people to improve and sustain mental well-being through participation in meaningful activity. The aim is to enable participants to engage in both new and neglected activities through a mix of facilitated group meetings and individual sessions. Results The fidelity assessment demonstrated that the intervention was delivered as per protocol for the group component and was tailored to meet individual needs. There was substantial inter-rater agreement for training; and group member performance 0.72; and moderate agreement for facilitator performance 0.55. It was not possible to determine whether small declines seen in facilitator performance were due to facilitator drift or moderating factors such as group dynamics or participant characteristics. Conclusions The assessment methods adequately measured criteria identified as being significant indicators of fidelity. Adherence during training, delivery and supervision was good. The subjective nature of identification and rating observed behaviours was the main challenge. Future research should explore alternative methods of assessing fidelity in trials of complex interventions. Trial registration number ISRCTN67209155.
| S-EPMC8039267 | biostudies-literature
Project description:IntroductionThe European population is rapidly ageing. In order to handle substantial future challenges in the healthcare system, we need to shift focus from treatment towards health promotion. The PreventIT project has adapted the Lifestyle-integrated Exercise (LiFE) programme and developed an intervention for healthy young older adults at risk of accelerated functional decline. The intervention targets balance, muscle strength and physical activity, and is delivered either via a smartphone application (enhanced LiFE, eLiFE) or by use of paper manuals (adapted LiFE, aLiFE).Methods and analysisThe PreventIT study is a multicentre, three-armed feasibility randomised controlled trial, comparing eLiFE and aLiFE against a control group that receives international guidelines of physical activity. It is performed in three European cities in Norway, Germany, and The Netherlands. The primary objective is to assess the feasibility and usability of the interventions, and to assess changes in daily life function as measured by the Late-Life Function and Disability Instrument scale and a physical behaviour complexity metric. Participants are assessed at baseline, after the 6 months intervention period and at 1 year after randomisation. Men and women between 61 and 70 years of age are randomly drawn from regional registries and respondents screened for risk of functional decline to recruit and randomise 180 participants (60 participants per study arm).Ethics and disseminationEthical approval was received at all three trial sites. Baseline results are intended to be published by late 2018, with final study findings expected in early 2019. Subgroup and further in-depth analyses will subsequently be published.Trial registration numberNCT03065088; Pre-results.
| S-EPMC6527989 | biostudies-literature
Project description:ObjectiveLifestyle intervention is recommended as first-line treatment of diabetes at all ages; however, little is known about the efficacy of lifestyle intervention in older adults with diabetes. We aimed to determine whether lifestyle intervention would improve glycemic control and age-relevant outcomes in older adults with diabetes and comorbidities.Research design and methodsA total of 100 older adults with diabetes were randomly assigned to 1-year intensive lifestyle intervention (ILI) (diet and exercise at a facility transitioned into community-fitness centers and homes) or healthy lifestyle (HL) group. The primary outcome was change in HbA1c. Secondary outcomes included glucoregulation, body composition, physical function, and quality of life. Changes between groups were analyzed with mixed-model repeated-measures ANCOVA following the intention-to-treat principle.ResultsHbA1c improved more in the ILI than the HL group (mean ± SE -0.8 ± 0.1 vs. 0.1 ± 0.1%), associated with improved insulin sensitivity (1.2 ± 0.2 vs. -0.4 ± 0.2) and disposition (26.0 ± 8.9 vs. -13.0 ± 8.4 109 min-1) indices (between-group P < 0.001 to 0.04). Body weight and visceral fat decreased more in the ILI than HL group (-8.4 ± 0.6 vs. -0.3 ± 0.6 kg, P < 0.001, and -261 ± 29 vs. -30 ± 27 cm3, P < 0.001, respectively). Physical Performance Test score increased more in the ILI than HL group (2.9 ± 0.6 vs. -0.1 ± 0.4, P < 0.001) as did VO2peak (2.2 ± 0.3 vs. -1.2 ± 0.2 mL/kg/min, P < 0.001). Strength, gait, and 36-Item Short Form Survey (SF-36) Physical Component Summary score also improved more in the ILI group (all P < 0.001). Total insulin dose decreased in the ILI group by 19.8 ± 4.4 units/day. Adverse events included increased episodes of mild hypoglycemia in the ILI group.ConclusionsA lifestyle intervention strategy is highly successful in improving metabolic and functional health of older adults with diabetes.
| S-EPMC9472494 | biostudies-literature
Project description:BackgroundRecruiting isolated older adults to clinical trials is complex, time-consuming and difficult. Previous studies have suggested querying existing databases to identify appropriate potential participants. We aim to compare recruitment techniques (general practitioner (GP) mail-outs, community engagement and clinician referrals) used in three randomised controlled trial (RCT) studies assessing the feasibility or effectiveness of two preventative interventions in isolated older adults (the Lifestyle Matters and Putting Life In Years interventions).MethodsDuring the three studies (the Lifestyle Matters feasibility study, the Lifestyle Matters RCT, the Putting Life In Years RCT) data were collected about how participants were recruited. The number of letters sent by GP surgeries for each study was recorded. In the Lifestyle Matters RCT, we qualitatively interviewed participants and intervention facilitators at 6 months post randomisation to seek their thoughts on the recruitment process.ResultsReferrals were planned to be the main source of recruitment in the Lifestyle Matters feasibility study, but due to a lack of engagement from district nurses, community engagement was the main source of recruitment. District nurse referrals and community engagement were also utilised in the Lifestyle Matters and Putting Life In Years RCTs; both mechanisms yielded few participants. GP mail-outs were the main source of recruitment in both the RCTs, but of those contacted, recruiting yield was low (< 3%). Facilitators of the Lifestyle Matters intervention questioned whether the most appropriate individuals had been recruited. Participants recommended that direct contact with health professionals would be the most beneficial way to recruit.ConclusionsRecruitment to the Lifestyle Matters RCT did not mirror recruitment to the feasibility study of the same intervention. Direct district nurse referrals were not effective at recruiting participants. The majority of participants were recruited via GP mail-outs, which may have led to isolated individuals not being recruited to the trials. Further research is required into alternative recruitment techniques, including respondent-driven sampling plus mechanisms which will promote health care professionals to recruit vulnerable populations to research.Trial registrationInternational Standard Randomised Controlled Trial Registry, ID: ISRCTN28645428 (Putting Life In Years RCT). Registered on 11 April 2012; International Standard Randomised Controlled Trial Registry, ID: ISRCTN67209155 (Lifestyle Matters RCT). Registered on 22 March 2012; ClinicalTrials.gov , ID: NCT03054311 (Lifestyle Matters feasibility study). Registered retrospectively on 19 January 2017.
| S-EPMC5819193 | biostudies-literature
Project description:Importance/Objective: To describe the feasibility and acceptability of a 6-month web-based multidomain lifestyle training intervention for community-dwelling older people and to test the effects of the intervention on both function- and lifestyle-related outcomes.Design6-month, parallel-group, randomized controlled trial (RCT).SettingToulouse area, South-West, France.ParticipantsCommunity-dwelling men and women, ? 65 years-old, presenting subjective memory complaint, without dementia.InterventionThe web-based multidomain intervention group (MIG) received a tablet to access the multidomain platform and a wrist-worn accelerometer measuring step counts; the control group (CG) received only the wrist-worn accelerometer. The multidomain platform was composed of nutritional advices, personalized exercise training, and cognitive training. Main outcomes and measures: Feasibility, defined as the proportion of people connecting to ?75% of the prescribed sessions, and acceptability, investigated through content analysis from recorded semi-structured interviews. Secondary outcomes included clinical (eg, cognitive function, mobility, health-related quality of life (HRQOL)) and lifestyle (eg, step count, food intake) measurements.ResultsAmong the 120 subjects (74.2 ±5.6 years-old; 57.5% women), 109 completed the study (n=54, MIG; n=55, CG). 58 MIG subjects connected to the multidomain platform at least once; among them, adherers of ?75% of sessions varied across multidomain components: 37 people (63.8% of 58 participants) for cognitive training, 35 (60.3%) for nutrition, and three (5.2%) for exercise; these three persons adhered to all multidomain components. Participants considered study procedures and multidomain content in a positive way; the most cited weaknesses were related to exercise: too easy, repetitive, and slow progression. Compared to controls, the intervention had a positive effect on HRQOL; no significant effects were observed across the other clinical and lifestyle outcomes.Conclusions and relevanceProviding multidomain lifestyle training through a web-platform is feasible and well-accepted, but the training should be challenging enough and adequately progress according to participants' capabilities to increase adherence. Recommendations for a larger on-line multidomain lifestyle training RCT are provided.
| S-EPMC7754697 | biostudies-literature
Project description:ObjectiveTo determine whether a multicomponent intervention based on physical activity with technological support and nutritional counselling prevents mobility disability in older adults with physical frailty and sarcopenia.DesignEvaluator blinded, randomised controlled trial.Setting16 clinical sites across 11 European countries, January 2016 to 31 October 2019.Participants1519 community dwelling men and women aged 70 years or older with physical frailty and sarcopenia, operationalised as the co-occurrence of low functional status, defined as a short physical performance battery (SPPB) score of 3 to 9, low appendicular lean mass, and ability to independently walk 400 m. 760 participants were randomised to a multicomponent intervention and 759 received education on healthy ageing (controls).InterventionsThe multicomponent intervention comprised moderate intensity physical activity twice weekly at a centre and up to four times weekly at home. Actimetry data were used to tailor the intervention. Participants also received personalised nutritional counselling. Control participants received education on healthy ageing once a month. Interventions and follow-up lasted for up to 36 months.Main outcome measuresThe primary outcome was mobility disability (inability to independently walk 400 m in <15 minutes). Persistent mobility disability (inability to walk 400 m on two consecutive occasions) and changes from baseline to 24 and 36 months in physical performance, muscle strength, and appendicular lean mass were analysed as pre-planned secondary outcomes. Primary comparisons were conducted in participants with baseline SPPB scores of 3-7 (n=1205). Those with SPPB scores of 8 or 9 (n=314) were analysed separately for exploratory purposes.ResultsMean age of the 1519 participants (1088 women) was 78.9 (standard deviation 5.8) years. The average follow-up was 26.4 (SD 9.5) months. Among participants with SPPB scores of 3-7, mobility disability occurred in 283/605 (46.8%) assigned to the multicomponent intervention and 316/600 (52.7%) controls (hazard ratio 0.78, 95% confidence interval 0.67 to 0.92; P=0.005). Persistent mobility disability occurred in 127/605 (21.0%) participants assigned to the multicomponent intervention and 150/600 (25.0%) controls (0.79, 0.62 to 1.01; P=0.06). The between group difference in SPPB score was 0.8 points (95% confidence interval 0.5 to 1.1 points; P<0.001) and 1.0 point (95% confidence interval 0.5 to 1.6 points; P<0.001) in favour of the multicomponent intervention at 24 and 36 months, respectively. The decline in handgrip strength at 24 months was smaller in women assigned to the multicomponent intervention than to control (0.9 kg, 95% confidence interval 0.1 to 1.6 kg; P=0.028). Women in the multicomponent intervention arm lost 0.24 kg and 0.49 kg less appendicular lean mass than controls at 24 months (95% confidence interval 0.10 to 0.39 kg; P<0.001) and 36 months (0.26 to 0.73 kg; P<0.001), respectively. Serious adverse events occurred in 237/605 (39.2%) participants assigned to the multicomponent intervention and 216/600 (36.0%) controls (risk ratio 1.09, 95% confidence interval 0.94 to 1.26). In participants with SPPB scores of 8 or 9, mobility disability occurred in 46/155 (29.7%) in the multicomponent intervention and 38/159 (23.9%) controls (hazard ratio 1.25, 95% confidence interval 0.79 to 1.95; P=0.34).ConclusionsA multicomponent intervention was associated with a reduction in the incidence of mobility disability in older adults with physical frailty and sarcopenia and SPPB scores of 3-7. Physical frailty and sarcopenia may be targeted to preserve mobility in vulnerable older people.Trial registrationClinicalTrials.gov NCT02582138.
| S-EPMC9092831 | biostudies-literature
Project description:Background: Meeting recruitment targets for randomised controlled trials is challenging. This trial evaluated the effectiveness of including a pen within the trial invitation pack on the recruitment of older adults into a randomised controlled trial. Methods: This trial was embedded within the Occupational Therapist Intervention Study, a falls-prevention randomised controlled trial. Potential participants (n = 1862), who were posted an invitation pack from two General Practitioner practices, were randomised to either not receive a pen (n = 1295) or receive a pen (n = 648) with their invitation pack, using a 2:1 ratio. The primary outcome was the likelihood of being randomised, and therefore fully recruited, to the host trial. To be randomised to the host trial, participants had to: return a consent form and screening form; be eligible on their screening form; and return a baseline questionnaire and a monthly falls calendar. Secondary outcomes were: the likelihood of returning (and time to return) a screening form; being eligible for the host trial; and remaining in the trial for at least 3 months. Results: The likelihood of being randomised to the host trial did not differ between the pen group (4.5%) and no pen group (4.3%; odds ratio 1.04; 95% confidence interval: 0.65 to 1.67; p = 0.86). There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant. Conclusion: Pens may not be an effective incentive for the recruitment of older adults into randomised controlled trials, though future trials are required. Registration: ISRCTN22202133; SWAT 37.
| S-EPMC6446499 | biostudies-other
Project description:BackgroundInteractive web-based physical activity interventions using Web 2.0 features (e.g., social networking) have the potential to improve engagement and effectiveness compared to static Web 1.0 interventions. However, older adults may engage with Web 2.0 interventions differently than younger adults. The aims of this study were to determine whether an interaction between intervention (Web 2.0 and Web 1.0) and age group (<55y and ≥55y) exists for website usage and to determine whether an interaction between intervention (Web 2.0, Web 1.0 and logbook) and age group (<55y and ≥55y) exists for intervention effectiveness (changes in physical activity).MethodsAs part of the WALK 2.0 trial, 504 Australian adults were randomly assigned to receive either a paper logbook (n = 171), a Web 1.0 (n = 165) or a Web 2.0 (n = 168) physical activity intervention. Moderate to vigorous physical activity was measured using ActiGraph monitors at baseline 3, 12 and 18 months. Website usage statistics including time on site, number of log-ins and number of step entries were also recorded. Generalised linear and intention-to-treat linear mixed models were used to test interactions between intervention and age groups (<55y and ≥55y) for website usage and moderate to vigorous physical activity changes.ResultsTime on site was higher for the Web 2.0 compared to the Web 1.0 intervention from baseline to 3 months, and this difference was significantly greater in the older group (OR = 1.47, 95%CI = 1.01-2.14, p = .047). Participants in the Web 2.0 group increased their activity more than the logbook group at 3 months, and this difference was significantly greater in the older group (moderate to vigorous physical activity adjusted mean difference = 13.74, 95%CI = 1.08-26.40 min per day, p = .03). No intervention by age interactions were observed for Web 1.0 and logbook groups.ConclusionsResults partially support the use of Web 2.0 features to improve adults over 55 s' engagement in and behaviour changes from web-based physical activity interventions.Trial registrationACTRN ACTRN12611000157976 , Registered 7 March 2011.
| S-EPMC5766986 | biostudies-literature
Project description:IntroductionChanging health behaviours is an important and difficult task. Despite growing interest in behavioural theories and models, there is a paucity of research examining their validity in explaining oral health behaviours, and there is a need for interventional studies to assess their effectiveness in improving oral health. This study aims to test the explanatory power of the dominant psychological theories, develop theory-derived intervention and evaluate its effectiveness in improving oral health of older adults.Methods and analysis440 community dwelling older adults will be recruited. To be eligible for this trial, one needs to be 55-79 years old, having at least 8 natural teeth, and with no life-threatening disease, impaired cognitive function, or radiotherapy in the head and neck region. At the initial visit, each participant will be required to complete a detailed questionnaire which collects information on sociodemographic background, oral health behaviours and domains of three psychological theories and models: (1) health belief model, (2) theory of planned behaviour and (3) social cognitive theory. The theory or model that best explains the health behaviours will be selected for designing the oral health intervention. The effectiveness of the theory-derived intervention will be evaluated in a randomised controlled trial. Participants will be randomly assigned to two groups, receiving theory-derived intervention and conventional health education, respectively. At baseline and at 12 and 24 months post intervention, each participant will complete a short questionnaire and undergo an oral examination (dental check-up). The effectiveness of the interventions will be evaluated using behavioural outcomes (diet, toothbrushing, interdental cleaning) and clinical outcomes (oral hygiene, dental caries and periodontal conditions).Ethics and disseminationThis study has been approved by the Institutional Review Board of National University of Singapore (Ref: NUS-IRB-2020-417). Findings will be presented in international conferences and peer-reviewed journals.Trial registration numberNCT04946292.
| S-EPMC9748933 | biostudies-literature
Project description:BACKGROUND:There has been an increasing interest in reablement in Norway recently and many municipalities have implemented this form of rehabilitation despite a lack of robust evidence of its effectiveness. The aim of this study was to investigate the effectiveness of reablement in home-dwelling older adults compared with usual care in relation to daily activities, physical functioning, and health-related quality of life. METHODS:This is a parallel-group randomised controlled trial conducted in a rural municipality in Norway. Sixty-one home-dwelling older adults with functional decline were randomised to an intervention group (n = 31) or a control group (n = 30). The intervention group received ten weeks of multicomponent home-based rehabilitation. The Canadian Occupational Performance Measure (COPM) was used to measure self-perceived activity performance and satisfaction with performance. In addition, physical capacity and health-related quality of life were measured. The participants were assessed at baseline and at 3- and 9-month follow-ups. RESULTS:There were significant improvements in mean scores favouring reablement in COPM performance at 3 months with a score of 1.5 points (p = 0.02), at 9 months 1.4 points (p = 0.03) and overall treatment 1.5 points (p = 0.01), and for COPM satisfaction at 9 months 1.4 points (p = 0.03) and overall treatment 1.2 points (p = 0.04). No significant group differences were found concerning COPM satisfaction at 3 months, physical capacity or health-related quality of life. CONCLUSION:A 10-week reablement program resulted in better activity performance and satisfaction with performance on a long-term basis, but not the other outcomes measured. TRIAL REGISTRATION:The trial was registered in ClinicalTrials.gov November 20, 2012, identifier NCT02043262 .
| S-EPMC4634595 | biostudies-literature