<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04440969</url>
  </required_header>
  <id_info>
    <org_study_id>GERI1613</org_study_id>
    <secondary_id>MOH/NIC/COG02/2017</secondary_id>
    <nct_id>NCT04440969</nct_id>
  </id_info>
  <brief_title>Evaluation of Pilot Community-based Multi-domain Program Older Adults at Risk of Cognitive Impairment</brief_title>
  <official_title>Dementia - Early Detection and Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geriatric Education and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Neeuro Pte Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ProAge Pte Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>KKT Technology Pte Ltd (Holmusk)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Geriatric Education and Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The multi-domain programme was adapted from a larger international multi-domain&#xD;
      interventional study for the Singapore community of older adults at risk of cognitive&#xD;
      impairment. This programme comprises nutritional, physical and cognitive components delivered&#xD;
      by implementation partners in the community. A dementia risk screening tool developed from&#xD;
      the Singapore Longitudinal Ageing Study (SLAS) data was used to screen potential&#xD;
      participants. The nutritional component includes nutrition guidance via a nutritional app,&#xD;
      while cognition component involves computerised training on a touch screen device and&#xD;
      physical aspects involves dual-task exercises.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Older people like to continue to think clearly, remember accurately, and make good decisions.&#xD;
      The loss of the ability to live independently is one of the greatest fears adults express&#xD;
      when considering old age. As physical fitness declines, the brain also ages. While cognition&#xD;
      in areas related to wisdom and experience improve in older adults, others like memory,&#xD;
      attention, and reaction time can decline and affect daily life. As life expectancy increases,&#xD;
      maintaining cognition is critical to productive and healthy aging. Older adults want to&#xD;
      continue to negotiate the environment, perform routine tasks (e.g. driving), learn new&#xD;
      things, and live independently. Cognitive impairment creates significant challenges for&#xD;
      individuals, their families and friends, and clinicians who provide their health care.&#xD;
      Furthermore, available research indicates that cognitive impairment is not detected in&#xD;
      substantial proportions of older people in primary care who have the condition. Early&#xD;
      detection allows for earlier diagnosis and appropriate intervention, education, psycho-social&#xD;
      support, and engagement in shared decision-making regarding life planning, financial matters,&#xD;
      and health care. Based on this, there is a need for scalable, implementable intervention&#xD;
      programmes which can be introduced in the community.&#xD;
&#xD;
      Previous studies have corroborated the efficacy of certain aspects of training which can&#xD;
      promote delay in cognitive decline. Specifically, these encompass nutritional, cognitive and&#xD;
      physical activity. Individually, these components have been extensively validated and proven&#xD;
      effective in negating cognitive decline. However, little attempts have been made to evaluate&#xD;
      the effectiveness and feasibility of combining these components into a multi-modal program.&#xD;
      The only preceding study to have proven efficacy of multi-modal programs in improving&#xD;
      cognition was carried out in the FINGER trial. However, to date, no similar studies have been&#xD;
      carried out locally. Therefore, this study aims to address these questions; by using a mixed&#xD;
      method approach; combining both qualitative and quantitative methods to assess the&#xD;
      achievability of such a programme.&#xD;
&#xD;
      The programme aims to identify individuals at risk of cognitive decline and is offered to&#xD;
      ensure intervention measures are adopted at early stages. The multi-domain program comprises&#xD;
      a combination of nutritional guidance, group physical activity and cognitive training&#xD;
      segments; all of which are individually regarded as proven interventions for cognitive&#xD;
      impairment. The program will be coordinated between three commercial entities, Holmusk,&#xD;
      Neeuro and ProAge and is funded by the National Innovation Challenge (NIC), MOH, Singapore.&#xD;
      As part of the programme, the investigators will be utilizing a locally developed risk score&#xD;
      created from the Singapore Longitudinal Aging study (SLAS), that can be widely administered&#xD;
      and is applicable to the local population. Therefore, the study aims to use a mixed methods&#xD;
      approach to evaluate:&#xD;
&#xD;
        1. The feasibility and sustainability of implementing the programme, which will be assessed&#xD;
           based on several considerations such as reach, implementation and maintenance or areas&#xD;
           of improvement.&#xD;
&#xD;
        2. The effectiveness of the programme on cognitive decline and improvement in fitness and&#xD;
           nutrition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2018</start_date>
  <completion_date type="Actual">March 4, 2020</completion_date>
  <primary_completion_date type="Actual">March 4, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in cognition at Week 12 and Week 48</measure>
    <time_frame>Baseline, Week 24 and Week 48</time_frame>
    <description>Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a cognitive test that consists of 12 subtests grouped into five domains - immediate and delayed memory, visuospatial/construction, language and attention. A higher score indicates better cognitive performance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in quality of life at Week 12 and Week 48</measure>
    <time_frame>Baseline, Week 24 and Week 48</time_frame>
    <description>Quality of Life Questionnaire (EuroQol EQ-5D-5L) index measures participants' perception of their ability to 1) self-care, 2) carry out usual activities, and their levels of 3) mobility, 4) pain/discomfort, and 5) anxiety/depression. The EQ-5D index is derived by combining responses from these 5 categories. A higher index indicates higher quality of life. EQ-5D Visual Analogue Scale (VAS) is a 0 - 100 scale that measures participants' perception of their health status on the day this scale was used, with 100 signifying the best possible state of health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in aerobic strength at Week 12 and Week 48</measure>
    <time_frame>Baseline, Week 24 and Week 48</time_frame>
    <description>Two-minute step test is a test of aerobic endurance, where participants are required to take as many steps (marching on the spot) as possible in two minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in leg strength at Week 12 and Week 48</measure>
    <time_frame>Baseline, Week 24 and Week 48</time_frame>
    <description>Chair stand is a test of leg strength where participants are required to stand up from seated position as many times as possible in thirty seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in arm strength at Week 12 and Week 48</measure>
    <time_frame>Baseline, Week 24 and Week 48</time_frame>
    <description>Handgrip strength is a test of hand and forearm muscular strength, where participants are required to squeeze a dynamometer as hard as possible. Units are measured in kilogrammes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in blood lipid levels at Week 12 and Week 48</measure>
    <time_frame>Baseline, Week 24 and Week 48</time_frame>
    <description>Fasting blood sample collected via fingerprick to measure blood lipid levels on a rapid blood kit (Cholesh LDX, Abbott, IL, U.S)</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation questionnaire</measure>
    <time_frame>Week 24 and Week 48</time_frame>
    <description>The questionnaire is to address some points of the REAIM framework, which stands for Reach, Effectiveness, Adoption, Implementation and Maintenance.&#xD;
Questions are either delivered on a 5-point Likert Scale for quantitative analysis (e.g.Did you find the exercises easy to follow? 1 - Extremely difficult, 2 - Quite difficult, 3 - Neutral, 4 - Quite easy, 5 - Extremely easy or as open ended questions for qualitative analysis (e.g. Are there barriers that will prevent you from taking up the programme?) Questionnaires are delivered to participants, centre managers and implementation partners.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">199</enrollment>
  <condition>Cognitive Decline</condition>
  <condition>Cognitive Impairment, Mild</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention administered is bi-weekly dual-task exercises, small group acitivites and computerised cognitive training for a total of 24 weeks. (Week 1 - 24)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention administered is bi-weekly dual-task exercises, small group acitivites and computerised cognitive training for a total of 24 weeks after Intervention Group has completed intervention. (Week 25 - 48)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multi-domain intervention</intervention_name>
    <description>Participants will undergo dual-task physical exercises and small group activities comprising of quizzes, puzzles and simulate daily living activities that have been gamified (Mindfun and MindGym, ProAge,Singapore). They will also play games on a touch screen device (computerised cognitive training) that aims to improve cognition in the domains of attention, memory, spatial ability, decision making and cognitive flexibility (Memorie, Neeuro, Singapore) while wearing the Senzeband, which emits low frequency signals on the forehead picked up by four individual sensors, allowing participant to play certain games without touching the device but by attention and focus (https://www.neeuro.com/senzeband).&#xD;
Dietary guidance will be delivered via a dietary app (Glycoleap). Participants are expected to take photos of their meals daily and upload them onto the app. Certified dieticians will give advice and tips on their choice of food and how to make healthier choices through the app.</description>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_label>Wait-list control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Above 55 years of age&#xD;
&#xD;
          -  Interested &amp; willing to participate in a lifestyle &amp; cognition training programme&#xD;
&#xD;
          -  Residing in Singapore over the next 1 year&#xD;
&#xD;
          -  Have a risk score of more than 6-8, implying a 10-20% risk of developing cognitive&#xD;
             decline over the next 5 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with cognitive disorders such as mild cognitive impairment, dementia or&#xD;
             Parkinson's Disease&#xD;
&#xD;
          -  Wheelchair bound&#xD;
&#xD;
          -  Total hearing or visual impairment&#xD;
&#xD;
          -  Medical instructions prohibiting participation in the programme&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shiou Liang Wee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geriatric Education and Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geriatric Education And Research Institute</name>
      <address>
        <city>Singapore</city>
        <zip>768024</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Lustig C, Shah P, Seidler R, Reuter-Lorenz PA. Aging, training, and the brain: a review and future directions. Neuropsychol Rev. 2009 Dec;19(4):504-22. doi: 10.1007/s11065-009-9119-9. Epub 2009 Oct 30.</citation>
    <PMID>19876740</PMID>
  </reference>
  <reference>
    <citation>Morley JE, Morris JC, Berg-Weger M, Borson S, Carpenter BD, Del Campo N, Dubois B, Fargo K, Fitten LJ, Flaherty JH, Ganguli M, Grossberg GT, Malmstrom TK, Petersen RD, Rodriguez C, Saykin AJ, Scheltens P, Tangalos EG, Verghese J, Wilcock G, Winblad B, Woo J, Vellas B. Brain health: the importance of recognizing cognitive impairment: an IAGG consensus conference. J Am Med Dir Assoc. 2015 Sep 1;16(9):731-9. doi: 10.1016/j.jamda.2015.06.017.</citation>
    <PMID>26315321</PMID>
  </reference>
  <reference>
    <citation>Ahlskog JE, Geda YE, Graff-Radford NR, Petersen RC. Physical exercise as a preventive or disease-modifying treatment of dementia and brain aging. Mayo Clin Proc. 2011 Sep;86(9):876-84. doi: 10.4065/mcp.2011.0252.</citation>
    <PMID>21878600</PMID>
  </reference>
  <reference>
    <citation>Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.</citation>
    <PMID>23332672</PMID>
  </reference>
  <reference>
    <citation>Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.</citation>
    <PMID>25771249</PMID>
  </reference>
  <reference>
    <citation>Smith PJ, Blumenthal JA. Diet and neurocognition: review of evidence and methodological considerations. Curr Aging Sci. 2010 Feb;3(1):57-66. doi: 10.2174/1874609811003010057.</citation>
    <PMID>20298171</PMID>
  </reference>
  <reference>
    <citation>Rawtaer I, Feng L, Yuen VH, Li J, Chong MS, Lim WS, Lee TS, Qiu C, Feng L, Kua EH, Ng TP. A Risk Score for the Prediction of Neurocognitive Disorders among Community-Dwelling Chinese Older Adults. Dement Geriatr Cogn Disord. 2016;41(5-6):348-58. doi: 10.1159/000447448. Epub 2016 Jul 20.</citation>
    <PMID>27433801</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Due to confidentiality issues, individual participant data will not be made public but de-identified data can be obtained upon request.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04440969
org study id: GERI1613
secondary id: MOH/NIC/COG02/2017
nct id: NCT04440969
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The multi-domain programme was adapted from a larger international multi-domain
      interventional study for the Singapore community of older adults at risk of cognitive
      impairment. This programme comprises nutritional, physical and cognitive components delivered
      by implementation partners in the community. A dementia risk screening tool developed from
      the Singapore Longitudinal Ageing Study (SLAS) data was used to screen potential
      participants. The nutritional component includes nutrition guidance via a nutritional app,
      while cognition component involves computerised training on a touch screen device and
      physical aspects involves dual-task exercises.
Older people like to continue to think clearly, remember accurately, and make good decisions.
      The loss of the ability to live independently is one of the greatest fears adults express
      when considering old age. As physical fitness declines, the brain also ages. While cognition
      in areas related to wisdom and experience improve in older adults, others like memory,
      attention, and reaction time can decline and affect daily life. As life expectancy increases,
      maintaining cognition is critical to productive and healthy aging. Older adults want to
      continue to negotiate the environment, perform routine tasks (e.g. driving), learn new
      things, and live independently. Cognitive impairment creates significant challenges for
      individuals, their families and friends, and clinicians who provide their health care.
      Furthermore, available research indicates that cognitive impairment is not detected in
      substantial proportions of older people in primary care who have the condition. Early
      detection allows for earlier diagnosis and appropriate intervention, education, psycho-social
      support, and engagement in shared decision-making regarding life planning, financial matters,
      and health care. Based on this, there is a need for scalable, implementable intervention
      programmes which can be introduced in the community.

      Previous studies have corroborated the efficacy of certain aspects of training which can
      promote delay in cognitive decline. Specifically, these encompass nutritional, cognitive and
      physical activity. Individually, these components have been extensively validated and proven
      effective in negating cognitive decline. However, little attempts have been made to evaluate
      the effectiveness and feasibility of combining these components into a multi-modal program.
      The only preceding study to have proven efficacy of multi-modal programs in improving
      cognition was carried out in the FINGER trial. However, to date, no similar studies have been
      carried out locally. Therefore, this study aims to address these questions; by using a mixed
      method approach; combining both qualitative and quantitative methods to assess the
      achievability of such a programme.

      The programme aims to identify individuals at risk of cognitive decline and is offered to
      ensure intervention measures are adopted at early stages. The multi-domain program comprises
      a combination of nutritional guidance, group physical activity and cognitive training
      segments; all of which are individually regarded as proven interventions for cognitive
      impairment. The program will be coordinated between three commercial entities, Holmusk,
      Neeuro and ProAge and is funded by the National Innovation Challenge (NIC), MOH, Singapore.
      As part of the programme, the investigators will be utilizing a locally developed risk score
      created from the Singapore Longitudinal Aging study (SLAS), that can be widely administered
      and is applicable to the local population. Therefore, the study aims to use a mixed methods
      approach to evaluate:

        1. The feasibility and sustainability of implementing the programme, which will be assessed
           based on several considerations such as reach, implementation and maintenance or areas
           of improvement.

        2. The effectiveness of the programme on cognitive decline and improvement in fitness and
           nutrition.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Change from baseline in cognition at Week 12 and Week 48
time frame: Baseline, Week 24 and Week 48
description: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a cognitive test that consists of 12 subtests grouped into five domains - immediate and delayed memory, visuospatial/construction, language and attention. A higher score indicates better cognitive performance.
measure: Change from baseline in quality of life at Week 12 and Week 48
time frame: Baseline, Week 24 and Week 48
description: Quality of Life Questionnaire (EuroQol EQ-5D-5L) index measures participants' perception of their ability to 1) self-care, 2) carry out usual activities, and their levels of 3) mobility, 4) pain/discomfort, and 5) anxiety/depression. The EQ-5D index is derived by combining responses from these 5 categories. A higher index indicates higher quality of life. EQ-5D Visual Analogue Scale (VAS) is a 0 - 100 scale that measures participants' perception of their health status on the day this scale was used, with 100 signifying the best possible state of health.
measure: Change from baseline in aerobic strength at Week 12 and Week 48
time frame: Baseline, Week 24 and Week 48
description: Two-minute step test is a test of aerobic endurance, where participants are required to take as many steps (marching on the spot) as possible in two minutes.
measure: Change from baseline in leg strength at Week 12 and Week 48
time frame: Baseline, Week 24 and Week 48
description: Chair stand is a test of leg strength where participants are required to stand up from seated position as many times as possible in thirty seconds
measure: Change from baseline in arm strength at Week 12 and Week 48
time frame: Baseline, Week 24 and Week 48
description: Handgrip strength is a test of hand and forearm muscular strength, where participants are required to squeeze a dynamometer as hard as possible. Units are measured in kilogrammes.
measure: Change from baseline in blood lipid levels at Week 12 and Week 48
time frame: Baseline, Week 24 and Week 48
description: Fasting blood sample collected via fingerprick to measure blood lipid levels on a rapid blood kit (Cholesh LDX, Abbott, IL, U.S)
measure: Evaluation questionnaire
time frame: Week 24 and Week 48
description: The questionnaire is to address some points of the REAIM framework, which stands for Reach, Effectiveness, Adoption, Implementation and Maintenance.
Questions are either delivered on a 5-point Likert Scale for quantitative analysis (e.g.Did you find the exercises easy to follow? 1 - Extremely difficult, 2 - Quite difficult, 3 - Neutral, 4 - Quite easy, 5 - Extremely easy or as open ended questions for qualitative analysis (e.g. Are there barriers that will prevent you from taking up the programme?) Questionnaires are delivered to participants, centre managers and implementation partners.
arm group label: Intervention
arm group type: Experimental
description: Intervention administered is bi-weekly dual-task exercises, small group acitivites and computerised cognitive training for a total of 24 weeks. (Week 1 - 24)
arm group label: Wait-list control
arm group type: Experimental
description: Intervention administered is bi-weekly dual-task exercises, small group acitivites and computerised cognitive training for a total of 24 weeks after Intervention Group has completed intervention. (Week 25 - 48)
intervention type: Behavioral
intervention name: Multi-domain intervention
description: Participants will undergo dual-task physical exercises and small group activities comprising of quizzes, puzzles and simulate daily living activities that have been gamified (Mindfun and MindGym, ProAge,Singapore). They will also play games on a touch screen device (computerised cognitive training) that aims to improve cognition in the domains of attention, memory, spatial ability, decision making and cognitive flexibility (Memorie, Neeuro, Singapore) while wearing the Senzeband, which emits low frequency signals on the forehead picked up by four individual sensors, allowing participant to play certain games without touching the device but by attention and focus (https://www.neeuro.com/senzeband).
Dietary guidance will be delivered via a dietary app (Glycoleap). Participants are expected to take photos of their meals daily and upload them onto the app. Certified dieticians will give advice and tips on their choice of food and how to make healthier choices through the app.
arm group label: Intervention
arm group label: Wait-list control
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Shiou Liang Wee, PhD
role: Principal Investigator
affiliation: Geriatric Education and Research Institute
facility: 
country: Singapore
citation: Lustig C, Shah P, Seidler R, Reuter-Lorenz PA. Aging, training, and the brain: a review and future directions. Neuropsychol Rev. 2009 Dec;19(4):504-22. doi: 10.1007/s11065-009-9119-9. Epub 2009 Oct 30.
PMID: 19876740
citation: Morley JE, Morris JC, Berg-Weger M, Borson S, Carpenter BD, Del Campo N, Dubois B, Fargo K, Fitten LJ, Flaherty JH, Ganguli M, Grossberg GT, Malmstrom TK, Petersen RD, Rodriguez C, Saykin AJ, Scheltens P, Tangalos EG, Verghese J, Wilcock G, Winblad B, Woo J, Vellas B. Brain health: the importance of recognizing cognitive impairment: an IAGG consensus conference. J Am Med Dir Assoc. 2015 Sep 1;16(9):731-9. doi: 10.1016/j.jamda.2015.06.017.
PMID: 26315321
citation: Ahlskog JE, Geda YE, Graff-Radford NR, Petersen RC. Physical exercise as a preventive or disease-modifying treatment of dementia and brain aging. Mayo Clin Proc. 2011 Sep;86(9):876-84. doi: 10.4065/mcp.2011.0252.
PMID: 21878600
citation: Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.
PMID: 23332672
citation: Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
PMID: 25771249
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PMID: 20298171
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PMID: 27433801
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: No
ipd description: Due to confidentiality issues, individual participant data will not be made public but de-identified data can be obtained upon request.