1、STUDY PROTOCOLDevelopment,implementation and evaluationof the online Movement,Interaction andNutrition for Greater Lifestyles in the Elderly(MINGLE)program:The protocol for a pilottrialDiana TangID1*,Rona MacnivenID1,2,Nicholas Bender3,Charlotte Jones4,Bamini Gopinath11 Macquarie University Hearing,
2、Macquarie University,North Ryde,New South Wales,Australia,2 School ofPopulation Health,Faculty of Medicine and Health,UNSW Sydney,Kensington,New South Wales,Australia,3 Middlesex University,The Burroughs,London,United Kingdom,4 Southern Medical Program,Universityof British Columbia,Okanagan Campus,K
3、elowna,Canada*d.tangmq.edu.auAbstractIntroductionPeople with age-related macular degeneration(AMD)are more likely to experience loneli-ness,have poorer diets and be less physically active than people without AMD.The onlineMovement,Interaction and Nutrition for Greater Lifestyles in the Elderly(MINGL
4、E)programis a holistic evidence-based intervention aiming to support people with AMD by incorporatingphysical activity,social interaction and nutrition education components all delivered via aCOVID-19-safe Zoom platform.This study will involve two phases:1)a formative qualitativestudy with AMD patie
5、nts to identify the barriers and facilitators to participating in the pro-posed MINGLE program;and 2)a 10-week pilot study to evaluate the feasibility,acceptabil-ity and preliminary efficacy of MINGLE.Methods and analysisPhase 1 involves AMD patients who will be recruited from an eye clinic in Weste
6、rn Sydney,Australia to participate in audio-recorded semi-structured interviews.Verbatim interviewtranscripts will be coded using the Capability,Opportunity,Motivation and Behaviour(COM-B)model and themes established.These themes will be used as a guide to specifically tailorthe proposed MINGLE prog
7、ram to people with AMD.Phase 2 involves 52 AMD patientswho will then be recruited from the same clinic to participate in the MINGLE program.Pre-post questionnaires will be administered to intervention participants to collect information onthe following variables:demographics,socioeconomic status,vis
8、ion function,loneliness,quality of life(including depression),falls risk,physical activity(level),and dietary intake.The acceptability and feasibility of the MINGLE program will also be evaluated usingdescriptive statistics.PLOS ONEPLOS ONE|https:/doi.org/10.1371/journal.pone.0267581 May 12,2022 1/1
9、2a1111111111a1111111111a1111111111a1111111111a1111111111OPEN ACCESSCitation:Tang D,Macniven R,Bender N,Jones C,Gopinath B(2022)Development,implementationand evaluation of the online Movement,Interactionand Nutrition for Greater Lifestyles in the Elderly(MINGLE)program:The protocol for a pilot trial.
10、PLoS ONE 17(5):e0267581.https:/doi.org/10.1371/journal.pone.0267581Editor:Walid Kamal Abdelbasset,Prince SattamBin Abdulaziz University,College of Applied MedicalSciences,SAUDI ARABIAReceived:August 19,2021Accepted:March 16,2022Published:May 12,2022Peer Review History:PLOS recognizes thebenefits of
11、transparency in the peer reviewprocess;therefore,we enable the publication ofall of the content of peer review and authorresponses alongside final,published articles.Theeditorial history of this article is available here:https:/doi.org/10.1371/journal.pone.0267581Copyright:2022 Tang et al.This is an
12、 openaccess article distributed under the terms of theCreative Commons Attribution License,whichpermits unrestricted use,distribution,andreproduction in any medium,provided the originalauthor and source are credited.Data Availability Statement:No datasets weregenerated or analysed during the current
13、 study.AllTrial registration numberACTRN12621000939897p.IntroductionAge-related macular degeneration(AMD)is the leading cause of vision loss and blindness inhigh income countries with an expected global prevalence of approximately 300 million by2040 1.Vision loss also has wider health impacts and ha
14、s been associated with higher rates ofloneliness,reduced quality-of-life,and increased falls risk 24.Among older adults in partic-ular,the research literature shows that loneliness is more prevalent in visually impaired elderlythan normal sighted elderly 3,4.Examples of this include a Dutch study wh
15、ich reported asignificant difference of 21%more visually impaired older adults experiencing feelings of lone-liness compared to normal sighted older adults(50%vs.29%,respectively)3.Another studyin Norway showed that among adults aged 66 years,there were 8.7%and 8.6%more visuallyimpaired elderly suff
16、ering from moderate and severe loneliness,respectively,compared to thegeneral Norwegian population of elderly 4.Feelings of loneliness have also been associated with depressive symptoms 5,where thelatter is already prevalent in up to 63%of visually impaired older adults including individualsexperien
17、cing minimal vision loss 2.Moreover,persistent loneliness can also lead to poorerlifestyle behaviours 6,7,which is particularly concerning for people with AMD,as growingresearch evidence supports an association between lifestyle risk factors such as a poor diet andlow levels of physical activity wit
18、h an increased risk of AMD development and/or progression810.Persistent loneliness has also been linked to other health outcomes including dementiaand cardiovascular health risks 6,7,11,12.Therefore,there is a strong need for evidence-based intervention programs focused on reducing loneliness in vis
19、ually impaired older adults,such as those diagnosed with AMD.Lifestyle interventions that include education,behaviour change and/or group supportcomponents can be effective in reducing loneliness and depression in older adults 13,14.One example of an evidence-based intervention is the Walk N Talk fo
20、r your Life(WTL)pro-gram that was developed by our group in 2014 for low-income older adults in Canada 15.This 12-week WTL program is ongoing and includes group walking;resistance training andbalance exercises;and discussion of health topics 15.Since its inception in 2014,more than300 older adults h
21、ave participated in this community-based,student and volunteer-run pro-gram across multiple locations 15.With the success of WTL,we also developed a virtualadaptation of WTL hosted over Zoom(WTL-Z)Zoom Communications Inc.2016 toaddress the safety concerns related to COVID-19,particularly amongst vul
22、nerable populationssuch as older adults.In 2021,a mixed methods randomised controlled trial(RCT)of WTL-Zinvolving 75 older adults in the United Kingdom was conducted as part of an unpublishedMaster of Research dissertation Bender et al.,Walk and Talk for Your Life:hosted overZoom:A mixed methods stu
23、dy on the effects of an online,videoconference-based group exer-cise and health discussion intervention on mental health in older adults affected by COVID-19social distancing restrictions.After 10-weeks,participants who underwent the WTL-Z inter-vention(n=35)reduced their feelings of loneliness by 2
24、5%and depressive symptoms fell by30%compared to the control group(n=40)whos baseline measurements did not improvesignificantly over this time.Initial qualitative analysis indicated WTL-Z was feasible and well-received by the participants.Other adaptations of WTL include the Walk,Talk and ListenPLOS
25、ONE An online MINGLE program:The protocol for a pilot trialPLOS ONE|https:/doi.org/10.1371/journal.pone.0267581 May 12,2022 2/12relevant data from this study will be made availableupon study completion.Funding:D.T,R.M,C.J,and B.G were awarded theMacular Disease Foundation Australia ResearchGrant by
26、the Macular Disease Foundation Australiato conduct this research project.https:/.au/The funders had and willhave a role in the study design,data collection andanalysis,decision to publish or preparation of themanuscript.Competing interests:The authors have declaredthat no competing interests exist.p
27、ilot randomised controlled trial targeting functional fitness and loneliness in older adultswith hearing loss(n=66)16.This intervention adapted the successful socialisation and exer-cise components of WTL and incorporated group auditory rehabilitation to educate partici-pants about hearing and avail
28、able supporting devices,improve communication skills andprovide psychosocial support 16.Walk,Talk and Listen showed significant improvement inemotional and social loneliness and hearing-related quality of life in relation to group auditoryrehabilitation attendance and poorer baseline hearing-related
29、 quality of life 16.Amongst people with AMD,positive participant responses to virtual programs have alsobeen reported in another evidence-based intervention developed by our group,which aimedto improve the dietary intakes of people with AMD through telehealth nutrition intervention17.This telehealth
30、 intervention involved the provision of an evidence-based workbook onnutrition and AMD links,together with monthly individual phone calls with a dietitian overfour months,which significantly improved the participants dietary intake of nutrient-richdark green leafy vegetables and legumes and reduced
31、consumption of packaged and processedfoods 17.To address the impacts of vision loss caused by AMD,including the increased prevalence ofloneliness,depression and falls risk,as well as to improve AMD-related lifestyle risk factors(poor diet and physical inactivity),we aimed to build on our prior resea
32、rch by developing aholistic program called MINGLE(Movement,Interaction and Nutrition for Greater Lifestylesin the Elderly)and piloting this novel program in a sample of older Australian adults withAMD.Therefore,this study aims to:1)develop the MINGLE program tailored to AMDpatients,by incorporating
33、the successful aspects of existing evidence-based interventionsdeveloped by our group(WTL-Z and a dietary intervention 17);and 2)deliver the MINGLEprogram online via Zoom 18 in a non-randomised group of AMD patients.Although ourprior research has shown that online delivery of WTL-Z can effectively r
34、educe loneliness anddepression,this study was conducted in normal sighted older adults residing in the UK.Hence,this pilot study is needed to evaluate the acceptability and feasibility of delivering theonline MINGLE program in visually impaired older adults.The aims of this study will beachieved thr
35、ough two phases.Phase 1 will conduct semi-structured interviews with AMDpatients to identify the barriers and facilitators to participating in the proposed MINGLE pro-gram;to determine the participants thoughts about MINGLE and what they would change orwould like included in the program and to accor
36、dingly modify the proposed MINGLE pro-gram to better suit the needs of people with AMD.Phase 2 will then involve a non-randomisedpilot trial of the modified MINGLE program in AMD patients to determine the programsacceptability and feasibility and its preliminary efficacy.Materials and methodsRecruit
37、mentThis study includes a qualitative component(semi-structured interviews)and a pilot trial ofthe MINGLE program(Fig 1).From October 2021,participants for both phases will berecruited by a research team member from a private eye clinic in Western Sydney,Australia.Recruitment processes will follow s
38、tate-based coronavirus-19(COVID-19)safety recommen-dations and thus,in the case of restrictions to in-person recruitment,participants will berecruited via telephone.Clinic staff will assist the researcher with telephone-based recruitmentfor both phases by providing the researcher with the contact de
39、tails of eligible participants whohave expressed an interest in participating in research projects.A flyer advertising each phaseof the study will also be placed at the clinic for patients who would like to contact theresearcher directly about participation in the study.PLOS ONE An online MINGLE pro
40、gram:The protocol for a pilot trialPLOS ONE|https:/doi.org/10.1371/journal.pone.0267581 May 12,2022 3/12Fig 1.MINGLE pilot trial schedule of enrolment,interventions,and assessments.https:/doi.org/10.1371/journal.pone.0267581.g001PLOS ONE An online MINGLE program:The protocol for a pilot trialPLOS ON
41、E|https:/doi.org/10.1371/journal.pone.0267581 May 12,2022 4/12Phase 1.Participants for the semi-structured interviews will be recruited over threemonths or until data saturation is achieved.Interviews will be conducted in-person in a privateroom at the eye clinic or over the telephone depending on t
42、he participants preference and/orCOVID-19 restrictions at the time.The inclusion criteria for Phase 1 are:1)diagnosis of anyform of AMD,2)fluent English and 3)consent to participate in the study(including audiorecording).Patient eligibility and interests will be screened by the researcher who will p
43、rovidean explanation of the study.Informed verbal consent will be audio recorded and documentedin a Record of Verbal Consent form.Phase 2.Recruitment for Phase 2 will commence after the preliminary findings fromPhase 1 have been identified.These findings will help to inform any modifications to the
44、MIN-GLE program prior to conducting the pilot study.Participants will be recruited over sixmonths or until the sample size target of 52 AMD patients is achieved.The inclusion criteriafor Phase 2 are:1)diagnosis of any form of AMD,2)fluent English,3)access to a smart phone,tablet or laptop with a fro
45、nt-facing camera;4)technical ability to use Zoom or have someoneto help;4)clearance to safely participate in the physical activity components of the interven-tion(Physical Activity Readiness Questionnaire(PARQ+19)or written physician clearancefor participation)and;5)written informed consent to parti
46、cipate.Specific exclusion criteriafor Phase 2 are:1)best-corrected visual acuity of worse than 6/60(legal blindness)in both eyes20;2)unable to ambulate/walk for exercise;3)serious illness(including mental and cognitiveillness)limiting their ability to exercise or complete the trial;4)contraindicatio
47、ns to exercise(i.e.,failure to fulfil the prerequisites of the PARQ+);5)uncontrolled hypertension(160/90mmHg);6)signs or symptoms of alcohol/substance abuse and;7)unable to commit to attend-ing80%of the sessions.Participation in Phase 1 of this study is not an exclusion criterion.Semi-structured int
48、erviews in Phase 1The semi-structured interviews are estimated to take 1520 minutes to complete(Table 1).The interview will include initial questions regarding:the participants AMD diagnosis and itsimpact on their day-to-day life;and any previous experience participating in lifestyle programsand ass
49、ociated details.This will be followed by discussions about the proposed MINGLE pro-gram including comments on the duration,frequency and preferred time to schedule the ses-sions;the suitability of the planned exercises and AMD-related nutrition education topics;aswell as any suggestions of content t
50、o include and/or exclude.The final interview questions willfocus on motivation to participate in the program such as potential barriers reducing motiva-tion and strategies to maintain motivation and commitment to completing the program.Intervention in Phase 2Using Phase 1 findings,the proposed MINGL
