<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/NCT04464538</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS280073</org_study_id>
    <nct_id>NCT04464538</nct_id>
  </id_info>
  <brief_title>Reducing Sedentary Behaviour and Cognition in Older People</brief_title>
  <official_title>Sedentary Behaviour and Cognitive Function in Community Dwelling Older People: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anglia Ruskin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cambridgeshire and Peterborough NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Anglia Ruskin University</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>
      Introduction Sedentary behaviour refers to activities of low energy expenditure in lying and&#xD;
      sitting positions. Examples include driving, watching television, playing cards, puzzles and&#xD;
      working on a computer. Studies suggest that between 60% of older people world-wide reported&#xD;
      sitting for more than four hours per day. Sedentary behaviour increases as older people&#xD;
      become older, have problems with cognition and when they are very ill. Excessive&#xD;
      participating in sedentary behaviours is associated with an increased risk of heart problem,&#xD;
      cancer death and diabetes. However, we do not know for certain whether or not participating&#xD;
      in sedentary behaviour could cause poorer cognition.&#xD;
&#xD;
      What does the study hope to achieve?&#xD;
&#xD;
      This feasibility study will test whether the main study, which is planned for later, is&#xD;
      workable with regards to the following:&#xD;
&#xD;
        -  Will reducing sedentary behaviour using our online health coaching intervention (WALC-R)&#xD;
           be acceptable to research participants and caregivers?&#xD;
&#xD;
        -  How many participants can be successfully recruited to the future trial?&#xD;
&#xD;
        -  What is the rate of adverse event associated with proposed study intervention?&#xD;
&#xD;
      Method:&#xD;
&#xD;
      This is a 13-week randomised feasibility study. We will randomly assign study participants to&#xD;
      either the health coaching intervention (WALC-R) or receiving health guidelines on&#xD;
      recommended physical activity. We aim to recruit 40 participants aged 50 and over who have&#xD;
      been diagnosed with Mild Cognitive Impairment.&#xD;
&#xD;
      The future main study will be larger and test whether:&#xD;
&#xD;
      • 'WALC-R', an online intervention designed to reduce participation in sedentary behaviour&#xD;
      can improve cognitive function in older people with Mild Cognitive Impairment compared with&#xD;
      providing an information sheet about physical activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background / Rationale The participation in sedentary behaviors is high among the older&#xD;
      population and increases with age co-morbidities and cognitive decline. 60% of older adults&#xD;
      world-wide reported sitting for more than four hours per day and when device-measured, 67% of&#xD;
      the older population were sedentary for more than 8.5 hours in their waking day (Harvey et&#xD;
      al., 2015). Further, recent policies of confinement and restriction stipulated by various&#xD;
      governments in response to the global COVID-19 pandemic is likely to encourage greater&#xD;
      participation in sedentary behavior (Ricci et al., 2020). There is evidence of deleterious&#xD;
      health implications of sedentary behaviors, with possible independent associations with&#xD;
      all-cause mortality, cardiovascular disease mortality, cardiovascular disease incidence,&#xD;
      cancer mortality, and type 2 diabetes incidence(Biswas and Alter, 2015). However, the&#xD;
      associations between sedentary behaviors and cognitive health are less clear and&#xD;
      inconclusive. A recent systematic review of 18 studies found inconclusive evidence on the&#xD;
      overall and independent associations between sedentary behaviors and cognitive function in&#xD;
      older adults (Olanrewaju et al., 2020). The review highlighted the lack of quality and&#xD;
      intervention studies of effect as one of the limitations of existing evidence.&#xD;
&#xD;
      There is some evidence that non-exercise and physical activity interventions could be&#xD;
      effective in reducing sedentary behaviors in older adults. A review of strategies to reduce&#xD;
      sedentary behavioural among adults found that the most promising interventions used&#xD;
      behavioural change techniques such as self-monitoring and problem solving(Gardner et al.,&#xD;
      2016). A recent meta-analysis of digital behavior change interventions (DBCI) in older adults&#xD;
      suggested that using platforms such as mobile applications, websites, wearable devices&#xD;
      reduced sedentary time by 58 minutes per day (SMD = -0.45; 95%CI -0.69, -0.19; p &lt; 0.001)&#xD;
      (Stockwell et al., 2019). A separate systematic review of interventions to reduce sedentary&#xD;
      behavior in non-working older adults found that interventions which incorporated goal&#xD;
      setting, individualized feedback, motivational sessions reduced objectively measured sitting&#xD;
      time by 3.2%-5.3% of waking time or up to 54 minutes per day (Aunger et al., 2018).&#xD;
&#xD;
      The WALC intervention (Walk; Address sensations; Learn; Cue) was originally designed to&#xD;
      motivate community-dwelling older adults to increase physical activity and is based on Social&#xD;
      Cognitive theory (Resnick, 2001). The WALC intervention is not a walking/physical activity&#xD;
      group, rather, a forum where the concept of sedentary behavior and strategies to reduce these&#xD;
      behaviours are coached. The WALC intervention has been validated in several studies for use&#xD;
      in the older population and people living with schizophrenia and more recently with serious&#xD;
      mental illness (Beebe and Smith, 2010; Resnick et al., 2007; Williams et al., 2019). This&#xD;
      study proposes to adopt the WALC intervention, which incorporates elements of the COM-B&#xD;
      behavioral change model to address capability, opportunity, and motivational barriers to&#xD;
      reduce sedentary behavior (Michie et al., 2011). Unlike original and previous versions of the&#xD;
      WALC intervention, we propose to deliver our intervention (WALC-R) remotely via the internet.&#xD;
      The WALC-R will consist of a group initial education session, fortnightly health coaching&#xD;
      sessions, and self-monitoring of daily activity levels using pedometer and diary. There is no&#xD;
      evidence on the effectiveness of non-exercise, sedentary behavior-reducing intervention on&#xD;
      cognitive function in the older population. Therefore, we propose to test the feasibility of&#xD;
      a remotely delivered health coaching intervention in older adults at risk of cognitive&#xD;
      decline with a view to test for effectiveness on cognitive function in a later study.&#xD;
&#xD;
      Aim To test the feasibility, acceptability and costs of delivering a virtual health coaching&#xD;
      intervention via the internet in community dwelling older people. This present proposal aims&#xD;
      to pave the way for a future randomized controlled trial by resolving key uncertainties in&#xD;
      its planning. The purpose of the future trial will be to test whether WALC-R intervention&#xD;
      compared with providing information about physical activity can improve cognitive function in&#xD;
      older adults with Mild Cognitive Impairment.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
        1. To determine the acceptability of intervention to participants&#xD;
&#xD;
        2. To determine feasibility of study with respect to the following:&#xD;
&#xD;
             1. Number of eligible patients&#xD;
&#xD;
             2. Recruitment and retention rates&#xD;
&#xD;
             3. Adherence / compliance rates&#xD;
&#xD;
             4. Collection of potential outcome measures for future trial (completion rates and&#xD;
                time)&#xD;
&#xD;
        3. To determine the costs associated with delivering intervention&#xD;
&#xD;
        4. To determine rate of adverse events in both groups.&#xD;
&#xD;
      Methods- Randomized Feasibility Study&#xD;
&#xD;
      Study design This will be a 13 week unblinded, single-centre randomized feasibility study.&#xD;
      The intervention is comprised of an initial group education session, fortnightly coaching&#xD;
      sessions and the provision of a pedometer and diary to enable participants monitor their&#xD;
      daily physical activity. Participants in the control group will receive information leaflets&#xD;
      which outlines the benefit of being physically active. The design will adhere to the&#xD;
      Consolidated Standards of Reporting Trials statement (CONSORT).&#xD;
&#xD;
      Setting and Participants The study will be conducted remotely in the community settings of&#xD;
      service users from Cambridgeshire and Peterborough NHS Foundation Trust (CPFT). Prior to&#xD;
      starting permissions will be sought from local Research Ethics Committees (REC), CPFT&#xD;
      Research and Development team and the National Research Authority.&#xD;
&#xD;
      Sampling Strategy Eligible patients who attend the memory clinics and / or receive support&#xD;
      from the older people mental health and healthy ageing services in Cambridgeshire and&#xD;
      Peterborough NHS Foundation Trust will be invited to participate.&#xD;
&#xD;
      Recruitment / Screening Potential participants would be primarily sought from the community&#xD;
      mental health, living well, memory services and general practitioners in Cambridgeshire and&#xD;
      Peterborough. A member of the clinical team will screen for potential participants for&#xD;
      initial eligibility (from medical notes, clinic records and/or clinical consultations) and,&#xD;
      if appropriate, given information about the trial. The clinician will then arrange an&#xD;
      appointment to discuss the trial, along with the opportunity to ask any questions. The&#xD;
      researcher will give people 24 hours to decide if they would like to participate. If they are&#xD;
      happy with the information they receive, they will be contacted by a member of the research&#xD;
      team to give informed consent. This study proposes to recruit patients with mild cognitive&#xD;
      impairment. Therefore a mental capacity test will be conducted during the process of consent&#xD;
      to ensure that participants understand, retain and weigh up the information available to make&#xD;
      a decision about consenting. Participants' general practitioners will be informed about their&#xD;
      enrolment onto the study. Once enrolled, participants will be asked to wear an accelerometer&#xD;
      for 7 days. Each participant will be reimbursed £10 for wearing the accelerometer. After&#xD;
      completion of the baseline measures, the participants will be informed of their allocation&#xD;
      status.&#xD;
&#xD;
      Proposed sample size and Justification Total sample sizes between 24 and 50 have been&#xD;
      recommended for feasibility studies. (18-20). Based on these recommendations, the study&#xD;
      proposes to enroll 40 participants, a target sample of 24 (12 per group) after factoring a&#xD;
      40% drop-out rate.&#xD;
&#xD;
      Randomization, Post-randomization withdrawals and exclusions This study proposes a simple&#xD;
      randomization of participants into intervention and control arms. Randomization process will&#xD;
      be overseen by the researcher using freely available software from Sealed Envelope:&#xD;
      https://www.sealedenvelope.com/help/simple-randomiser/students/. Participants will be&#xD;
      randomly allocated to receive either 'WALC-R' (intervention group) or information on&#xD;
      recommended physical activity for older adults (control group). Approximately 5 participants&#xD;
      will be randomized each month over 8 months. Subjects may discontinue participation in the&#xD;
      trial intervention and/or the trial at any time. Unless a subject explicitly withdraws their&#xD;
      consent, they will be followed-up wherever possible and data collected as per the protocol&#xD;
      until the end of the trial. Documentation will be completed on withdrawal to confirm the date&#xD;
      and reason for withdrawal.&#xD;
&#xD;
      Summary of Intervention Initial group education session (online) Participants assigned to the&#xD;
      WALC-R intervention will attend a virtual baseline educational group session which will&#xD;
      include a maximum of five people. The aim of the sessions will be to introduce the basics of&#xD;
      the benefits of walking for exercise and why exercise is beneficial, as well as to give&#xD;
      information, support and motivation to help participants to independently walk more in their&#xD;
      daily routines. In the group sessions, we will also introduce the concept of sedentary&#xD;
      behaviour and the harms and strategies to sit less and move more, including disrupting&#xD;
      prolonged periods of sitting. At the educational session, researchers will have information&#xD;
      on the participants' habitual levels of physical activity obtained from baseline data&#xD;
      collection. The group session will also include goal setting, in which participants will be&#xD;
      encouraged to set their own daily walking targets to increase their habitual levels of&#xD;
      walking. All participants will be given a pedometer to self-monitor how far they walk and a&#xD;
      diary to record activity context throughout the intervention daily.&#xD;
&#xD;
      Continuing support and coaching (online) Participants will meet briefly (20-30 minutes) via&#xD;
      the internet with an assigned worker (i.e., their coach) every 2 weeks. The participant and&#xD;
      coach will review the participant's walking calendar and address any barriers to and&#xD;
      facilitators of engaging in physical activity and reducing sedentary behaviour.&#xD;
&#xD;
      Control condition Participants in the control group will complete baseline measures, and then&#xD;
      they will receive written information on the benefits of increasing activity levels. This&#xD;
      advice will be given in accordance with NHS guide on physical health.&#xD;
&#xD;
      Follow-up assessment The follow-up assessment will be undertaken at the end of the&#xD;
      intervention after 13 weeks. At follow-up, all measures will be repeated (apart from&#xD;
      sociodemographic information). Each participant will receive a £10 voucher for wearing an&#xD;
      accelerometer. These assessments will be done by a research worker who is blind to allocation&#xD;
      status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2020</start_date>
  <completion_date type="Actual">October 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Unblinded, single-centre randomized feasibility study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of intervention assessed by semi-structured interviews</measure>
    <time_frame>Week 13</time_frame>
    <description>Acceptability of study intervention will be qualitatively assessed at the end of week 13 via semi-structured interviews with study participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>Week 13</time_frame>
    <description>Proportion of target recruit sample achieved throughout study duration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Completeness of intervention</measure>
    <time_frame>Week 13</time_frame>
    <description>Proportion of participants recruited into the study who completed the intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse event rate</measure>
    <time_frame>Week 13</time_frame>
    <description>Proportion of people recruited into the study who sustained adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device measured sedentary behaviour</measure>
    <time_frame>Week 1 and 13</time_frame>
    <description>Sedentary behaviour and physical activity time per day will be recorded using ActivPAL inclinometer.All participants will be required to wear the ActivPAL continuously for at least 7 days at baseline that will measure habitual sedentary behaviour and walking activity each day (Edwardson et al., 2017). The inclinometer will record how many minutes per day each participant is sedentary and engages in light, moderate and vigorous physical activities. A recording is made of each 60-second period (called an 'epoch'), and this is classified as being sedentary or light, moderate or vigorous physical activity. The researcher will collect data on the total minutes of sedentary behaviour per day, number of disruptions in sedentary behaviour and total time spent in physical activity (minutes per day in light, moderate and vigorous activity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self reported sedentary behaviour assessed using the Sedentary Behaviour Questionnaire</measure>
    <time_frame>Week 1 and 13</time_frame>
    <description>Participants will complete a survey questionnaire about weekly time spent participating in selected sedentary behaviours such as watching television and sitting (Rosenberg et al., 2010). The options for respondents include 'None', &lt;=15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6+ hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verbal fluency assessed using the Controlled and Oral Word Association Test (COWAT)</measure>
    <time_frame>Week 1 and 13</time_frame>
    <description>The researcher will test participant's verbal fluency (cognitive function) using the Controlled and Oral Word Association Test. The scores represent the number of correct words provided in 60 seconds. Higher scores represent better verbal fluency ability and vice versa.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived quality of life using the EuroQol five-dimension questionnaire (EQ-5D)</measure>
    <time_frame>Week 1 and 13</time_frame>
    <description>The participants will self- rate their health using five dimensions provided (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and five response levels: no problems, slight, moderate, severe, unable to/extreme problems. The EQ- Visual Analogue Scale(VAS) records the respondent's overall current health (0-100). Higher VAS scores represent best perceived health and vice versa.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-morbid intelligence</measure>
    <time_frame>Week 1 and 13</time_frame>
    <description>This will be evaluated using the National Adult Reading Test. Participants will be asked to read form a list of 50 words and they will be scored based on whether or not they pronounce each word correctly.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Health information</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in the control group will complete baseline measures, and then they will receive written information on the benefits of increasing activity levels. This advice will be given in accordance with NHS guide on physical health.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group education session and individualised coaching (online)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to the WALC-R intervention will attend a virtual baseline educational group session which will include a maximum of five people. The aim of the sessions will be to introduce the basics of the benefits of walking for exercise and why exercise is beneficial, as well as to give information, support and motivation to help participants to independently walk more in their daily routines.The group session will also include goal setting, in which participants will be encouraged to set their own daily walking targets to increase their habitual levels of walking. All participants will be given a pedometer to self-monitor how far they walk and a diary to record activity context throughout the intervention daily. Participants will meet briefly (20-30 minutes) via the internet with an assigned coach every 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>WALC-R</intervention_name>
    <description>Initial group education session and individualized coaching (remote)</description>
    <arm_group_label>Group education session and individualised coaching (online)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Information leaflet</intervention_name>
    <description>Participants in the control group will complete baseline measures, and then they will receive written information on the benefits of increasing activity levels. This advice will be given in accordance with NHS guide on physical health.</description>
    <arm_group_label>Health information</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Community dwelling adults aged 50+ years.&#xD;
&#xD;
          -  Doctor diagnosis of Mild Cognitive Impairment OR MCI diagnosis which meets Petersen&#xD;
             Criteria.&#xD;
&#xD;
          -  Participants must have a working knowledge of English.&#xD;
&#xD;
          -  Participants must be able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals diagnosed by doctor with dementia.&#xD;
&#xD;
          -  Individuals diagnosed with severe mental health conditions and substance use disorders&#xD;
             e.g. alcohol or drug abuse in within the last year.&#xD;
&#xD;
          -  Individuals with diagnosed neurological conditions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Queen Elizabeth Hospital NHS Foundation Trust</name>
      <address>
        <city>King's Lynn</city>
        <zip>PE30 4ET</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Olanrewaju, O. et al. (2022) 'Reducing sedentary behaviour and cognitive function in older people with Mild Cognitive Impairment: Results of a randomized feasibility study', Aging and Health Research, 2(1), p. 100057. doi: https://doi.org/10.1016/j.ahr.2022.100057.</citation>
  </results_reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Anglia Ruskin University</investigator_affiliation>
    <investigator_full_name>Olawale Olanrewaju</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Sedentary behaviour</keyword>
  <keyword>Cognitive function</keyword>
  <keyword>Feasibility study</keyword>
  <keyword>Older adults</keyword>
  <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>
  </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/NCT04464538
org study id: IRAS280073
nct id: NCT04464538
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction Sedentary behaviour refers to activities of low energy expenditure in lying and
      sitting positions. Examples include driving, watching television, playing cards, puzzles and
      working on a computer. Studies suggest that between 60% of older people world-wide reported
      sitting for more than four hours per day. Sedentary behaviour increases as older people
      become older, have problems with cognition and when they are very ill. Excessive
      participating in sedentary behaviours is associated with an increased risk of heart problem,
      cancer death and diabetes. However, we do not know for certain whether or not participating
      in sedentary behaviour could cause poorer cognition.

      What does the study hope to achieve?

      This feasibility study will test whether the main study, which is planned for later, is
      workable with regards to the following:

        -  Will reducing sedentary behaviour using our online health coaching intervention (WALC-R)
           be acceptable to research participants and caregivers?

        -  How many participants can be successfully recruited to the future trial?

        -  What is the rate of adverse event associated with proposed study intervention?

      Method:

      This is a 13-week randomised feasibility study. We will randomly assign study participants to
      either the health coaching intervention (WALC-R) or receiving health guidelines on
      recommended physical activity. We aim to recruit 40 participants aged 50 and over who have
      been diagnosed with Mild Cognitive Impairment.

      The future main study will be larger and test whether:

      • 'WALC-R', an online intervention designed to reduce participation in sedentary behaviour
      can improve cognitive function in older people with Mild Cognitive Impairment compared with
      providing an information sheet about physical activity.
Background / Rationale The participation in sedentary behaviors is high among the older
      population and increases with age co-morbidities and cognitive decline. 60% of older adults
      world-wide reported sitting for more than four hours per day and when device-measured, 67% of
      the older population were sedentary for more than 8.5 hours in their waking day (Harvey et
      al., 2015). Further, recent policies of confinement and restriction stipulated by various
      governments in response to the global COVID-19 pandemic is likely to encourage greater
      participation in sedentary behavior (Ricci et al., 2020). There is evidence of deleterious
      health implications of sedentary behaviors, with possible independent associations with
      all-cause mortality, cardiovascular disease mortality, cardiovascular disease incidence,
      cancer mortality, and type 2 diabetes incidence(Biswas and Alter, 2015). However, the
      associations between sedentary behaviors and cognitive health are less clear and
      inconclusive. A recent systematic review of 18 studies found inconclusive evidence on the
      overall and independent associations between sedentary behaviors and cognitive function in
      older adults (Olanrewaju et al., 2020). The review highlighted the lack of quality and
      intervention studies of effect as one of the limitations of existing evidence.

      There is some evidence that non-exercise and physical activity interventions could be
      effective in reducing sedentary behaviors in older adults. A review of strategies to reduce
      sedentary behavioural among adults found that the most promising interventions used
      behavioural change techniques such as self-monitoring and problem solving(Gardner et al.,
      2016). A recent meta-analysis of digital behavior change interventions (DBCI) in older adults
      suggested that using platforms such as mobile applications, websites, wearable devices
      reduced sedentary time by 58 minutes per day (SMD = -0.45; 95%CI -0.69, -0.19; p < 0.001)
      (Stockwell et al., 2019). A separate systematic review of interventions to reduce sedentary
      behavior in non-working older adults found that interventions which incorporated goal
      setting, individualized feedback, motivational sessions reduced objectively measured sitting
      time by 3.2%-5.3% of waking time or up to 54 minutes per day (Aunger et al., 2018).

      The WALC intervention (Walk; Address sensations; Learn; Cue) was originally designed to
      motivate community-dwelling older adults to increase physical activity and is based on Social
      Cognitive theory (Resnick, 2001). The WALC intervention is not a walking/physical activity
      group, rather, a forum where the concept of sedentary behavior and strategies to reduce these
      behaviours are coached. The WALC intervention has been validated in several studies for use
      in the older population and people living with schizophrenia and more recently with serious
      mental illness (Beebe and Smith, 2010; Resnick et al., 2007; Williams et al., 2019). This
      study proposes to adopt the WALC intervention, which incorporates elements of the COM-B
      behavioral change model to address capability, opportunity, and motivational barriers to
      reduce sedentary behavior (Michie et al., 2011). Unlike original and previous versions of the
      WALC intervention, we propose to deliver our intervention (WALC-R) remotely via the internet.
      The WALC-R will consist of a group initial education session, fortnightly health coaching
      sessions, and self-monitoring of daily activity levels using pedometer and diary. There is no
      evidence on the effectiveness of non-exercise, sedentary behavior-reducing intervention on
      cognitive function in the older population. Therefore, we propose to test the feasibility of
      a remotely delivered health coaching intervention in older adults at risk of cognitive
      decline with a view to test for effectiveness on cognitive function in a later study.

      Aim To test the feasibility, acceptability and costs of delivering a virtual health coaching
      intervention via the internet in community dwelling older people. This present proposal aims
      to pave the way for a future randomized controlled trial by resolving key uncertainties in
      its planning. The purpose of the future trial will be to test whether WALC-R intervention
      compared with providing information about physical activity can improve cognitive function in
      older adults with Mild Cognitive Impairment.

      Objectives

        1. To determine the acceptability of intervention to participants

        2. To determine feasibility of study with respect to the following:

             1. Number of eligible patients

             2. Recruitment and retention rates

             3. Adherence / compliance rates

             4. Collection of potential outcome measures for future trial (completion rates and
                time)

        3. To determine the costs associated with delivering intervention

        4. To determine rate of adverse events in both groups.

      Methods- Randomized Feasibility Study

      Study design This will be a 13 week unblinded, single-centre randomized feasibility study.
      The intervention is comprised of an initial group education session, fortnightly coaching
      sessions and the provision of a pedometer and diary to enable participants monitor their
      daily physical activity. Participants in the control group will receive information leaflets
      which outlines the benefit of being physically active. The design will adhere to the
      Consolidated Standards of Reporting Trials statement (CONSORT).

      Setting and Participants The study will be conducted remotely in the community settings of
      service users from Cambridgeshire and Peterborough NHS Foundation Trust (CPFT). Prior to
      starting permissions will be sought from local Research Ethics Committees (REC), CPFT
      Research and Development team and the National Research Authority.

      Sampling Strategy Eligible patients who attend the memory clinics and / or receive support
      from the older people mental health and healthy ageing services in Cambridgeshire and
      Peterborough NHS Foundation Trust will be invited to participate.

      Recruitment / Screening Potential participants would be primarily sought from the community
      mental health, living well, memory services and general practitioners in Cambridgeshire and
      Peterborough. A member of the clinical team will screen for potential participants for
      initial eligibility (from medical notes, clinic records and/or clinical consultations) and,
      if appropriate, given information about the trial. The clinician will then arrange an
      appointment to discuss the trial, along with the opportunity to ask any questions. The
      researcher will give people 24 hours to decide if they would like to participate. If they are
      happy with the information they receive, they will be contacted by a member of the research
      team to give informed consent. This study proposes to recruit patients with mild cognitive
      impairment. Therefore a mental capacity test will be conducted during the process of consent
      to ensure that participants understand, retain and weigh up the information available to make
      a decision about consenting. Participants' general practitioners will be informed about their
      enrolment onto the study. Once enrolled, participants will be asked to wear an accelerometer
      for 7 days. Each participant will be reimbursed £10 for wearing the accelerometer. After
      completion of the baseline measures, the participants will be informed of their allocation
      status.

      Proposed sample size and Justification Total sample sizes between 24 and 50 have been
      recommended for feasibility studies. (18-20). Based on these recommendations, the study
      proposes to enroll 40 participants, a target sample of 24 (12 per group) after factoring a
      40% drop-out rate.

      Randomization, Post-randomization withdrawals and exclusions This study proposes a simple
      randomization of participants into intervention and control arms. Randomization process will
      be overseen by the researcher using freely available software from Sealed Envelope:
      https://www.sealedenvelope.com/help/simple-randomiser/students/. Participants will be
      randomly allocated to receive either 'WALC-R' (intervention group) or information on
      recommended physical activity for older adults (control group). Approximately 5 participants
      will be randomized each month over 8 months. Subjects may discontinue participation in the
      trial intervention and/or the trial at any time. Unless a subject explicitly withdraws their
      consent, they will be followed-up wherever possible and data collected as per the protocol
      until the end of the trial. Documentation will be completed on withdrawal to confirm the date
      and reason for withdrawal.

      Summary of Intervention Initial group education session (online) Participants assigned to the
      WALC-R intervention will attend a virtual baseline educational group session which will
      include a maximum of five people. The aim of the sessions will be to introduce the basics of
      the benefits of walking for exercise and why exercise is beneficial, as well as to give
      information, support and motivation to help participants to independently walk more in their
      daily routines. In the group sessions, we will also introduce the concept of sedentary
      behaviour and the harms and strategies to sit less and move more, including disrupting
      prolonged periods of sitting. At the educational session, researchers will have information
      on the participants' habitual levels of physical activity obtained from baseline data
      collection. The group session will also include goal setting, in which participants will be
      encouraged to set their own daily walking targets to increase their habitual levels of
      walking. All participants will be given a pedometer to self-monitor how far they walk and a
      diary to record activity context throughout the intervention daily.

      Continuing support and coaching (online) Participants will meet briefly (20-30 minutes) via
      the internet with an assigned worker (i.e., their coach) every 2 weeks. The participant and
      coach will review the participant's walking calendar and address any barriers to and
      facilitators of engaging in physical activity and reducing sedentary behaviour.

      Control condition Participants in the control group will complete baseline measures, and then
      they will receive written information on the benefits of increasing activity levels. This
      advice will be given in accordance with NHS guide on physical health.

      Follow-up assessment The follow-up assessment will be undertaken at the end of the
      intervention after 13 weeks. At follow-up, all measures will be repeated (apart from
      sociodemographic information). Each participant will receive a £10 voucher for wearing an
      accelerometer. These assessments will be done by a research worker who is blind to allocation
      status.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Unblinded, single-centre randomized feasibility study
primary purpose: Other
masking: None (Open Label)
measure: Acceptability of intervention assessed by semi-structured interviews
time frame: Week 13
description: Acceptability of study intervention will be qualitatively assessed at the end of week 13 via semi-structured interviews with study participants.
measure: Recruitment rate
time frame: Week 13
description: Proportion of target recruit sample achieved throughout study duration.
measure: Completeness of intervention
time frame: Week 13
description: Proportion of participants recruited into the study who completed the intervention.
measure: Adverse event rate
time frame: Week 13
description: Proportion of people recruited into the study who sustained adverse events.
measure: Device measured sedentary behaviour
time frame: Week 1 and 13
description: Sedentary behaviour and physical activity time per day will be recorded using ActivPAL inclinometer.All participants will be required to wear the ActivPAL continuously for at least 7 days at baseline that will measure habitual sedentary behaviour and walking activity each day (Edwardson et al., 2017). The inclinometer will record how many minutes per day each participant is sedentary and engages in light, moderate and vigorous physical activities. A recording is made of each 60-second period (called an 'epoch'), and this is classified as being sedentary or light, moderate or vigorous physical activity. The researcher will collect data on the total minutes of sedentary behaviour per day, number of disruptions in sedentary behaviour and total time spent in physical activity (minutes per day in light, moderate and vigorous activity).
measure: Self reported sedentary behaviour assessed using the Sedentary Behaviour Questionnaire
time frame: Week 1 and 13
description: Participants will complete a survey questionnaire about weekly time spent participating in selected sedentary behaviours such as watching television and sitting (Rosenberg et al., 2010). The options for respondents include 'None', <=15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6+ hours.
measure: Verbal fluency assessed using the Controlled and Oral Word Association Test (COWAT)
time frame: Week 1 and 13
description: The researcher will test participant's verbal fluency (cognitive function) using the Controlled and Oral Word Association Test. The scores represent the number of correct words provided in 60 seconds. Higher scores represent better verbal fluency ability and vice versa.
measure: Perceived quality of life using the EuroQol five-dimension questionnaire (EQ-5D)
time frame: Week 1 and 13
description: The participants will self- rate their health using five dimensions provided (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and five response levels: no problems, slight, moderate, severe, unable to/extreme problems. The EQ- Visual Analogue Scale(VAS) records the respondent's overall current health (0-100). Higher VAS scores represent best perceived health and vice versa.
measure: Pre-morbid intelligence
time frame: Week 1 and 13
description: This will be evaluated using the National Adult Reading Test. Participants will be asked to read form a list of 50 words and they will be scored based on whether or not they pronounce each word correctly.
arm group label: Health information
arm group type: Placebo Comparator
description: Participants in the control group will complete baseline measures, and then they will receive written information on the benefits of increasing activity levels. This advice will be given in accordance with NHS guide on physical health.
arm group label: Group education session and individualised coaching (online)
arm group type: Experimental
description: Participants assigned to the WALC-R intervention will attend a virtual baseline educational group session which will include a maximum of five people. The aim of the sessions will be to introduce the basics of the benefits of walking for exercise and why exercise is beneficial, as well as to give information, support and motivation to help participants to independently walk more in their daily routines.The group session will also include goal setting, in which participants will be encouraged to set their own daily walking targets to increase their habitual levels of walking. All participants will be given a pedometer to self-monitor how far they walk and a diary to record activity context throughout the intervention daily. Participants will meet briefly (20-30 minutes) via the internet with an assigned coach every 2 weeks.
intervention type: Behavioral
intervention name: WALC-R
description: Initial group education session and individualized coaching (remote)
arm group label: Group education session and individualised coaching (online)
intervention type: Other
intervention name: Information leaflet
description: Participants in the control group will complete baseline measures, and then they will receive written information on the benefits of increasing activity levels. This advice will be given in accordance with NHS guide on physical health.
arm group label: Health information
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
citation: Olanrewaju, O. et al. (2022) 'Reducing sedentary behaviour and cognitive function in older people with Mild Cognitive Impairment: Results of a randomized feasibility study', Aging and Health Research, 2(1), p. 100057. doi: https://doi.org/10.1016/j.ahr.2022.100057.
responsible party type: Principal Investigator
investigator affiliation: Anglia Ruskin University
investigator full name: Olawale Olanrewaju
investigator title: Principal Investigator
mesh term: Cognitive Dysfunction
sharing ipd: No