xml: <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/NCT05980052</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00016394</org_study_id>
      <secondary_id>R61AG078089</secondary_id>
      <nct_id>NCT05980052</nct_id>
    </id_info>
    <brief_title>Goal Setting to Promote Physical Activity Adherence in Midlife Adults</brief_title>
    <official_title>Goal Setting to Promote Physical Activity Adherence in Midlife to Reduce Risk of Alzheimer's Disease and Related-Dementias: A Randomized Mechanistic Proof-Of-Concept Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Arizona State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Arizona State 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>
        Engaging in regular physical activity during midlife is a key lifestyle behavior associated&#xD;
        with reduced risk for Alzheimer's disease and related dementias (AD/ADRD). Yet nearly half of&#xD;
        midlife adults (48%) do not meet national physical activity guidelines. The purpose of this&#xD;
        mechanistic trial is to identify effective goal setting techniques to enhance psychosocial&#xD;
        processes of self-regulation for the successful promotion of PA and adherence to national PA&#xD;
        guidelines among midlife adults, with the long-term goal of reducing AD/ADRD risk&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        More than 6 million U.S. adults live with diagnoses of Alzheimer's Disease and Related&#xD;
        Dementias (AD/ADRD), with projections as high as 13.8 million cases by 2050. There are no&#xD;
        cures for AD/ADRD, making lifestyle factors key targets for reducing risk, as they account&#xD;
        for at least a third of AD/ADRD cases. Engaging in regular physical activity (PA),&#xD;
        particularly in midlife, is associated with reduced risk for AD/ADRD. Yet, nearly half of&#xD;
        midlife adults (48%) do not meet national PA guidelines of 150 minutes/week of&#xD;
        moderate-intensity PA. Goal setting is a commonly used behavior change strategy to increase&#xD;
        PA. Key psychosocial mechanisms believed to underpin the use of goal setting to promote PA&#xD;
        include self-regulation and self-efficacy. However, the most effective goal setting technique&#xD;
        to enhance these psychosocial mechanisms for the successful promotion of PA and adherence to&#xD;
        national PA guidelines remains unclear. In the proposed study, the investigators will use a&#xD;
        two-phased approach to empirically test three goal setting techniques to enhance psychosocial&#xD;
        mechanisms of self-regulation and self-efficacy for the successful promotion of PA and&#xD;
        adherence to national PA guidelines among insufficiently active midlife adults with obesity.&#xD;
        In the R61 phase, a Phase 1 pilot study will establish feasibility and help refine the&#xD;
        intervention. In the R33 phase, a Phase 2 9-month 4-arm proof-of-concept mechanistic trial&#xD;
        (6-month active intervention and 3-month no contact follow-up) will be implemented to&#xD;
        establish preliminary efficacy of goal setting techniques to increase PA and promote&#xD;
        adherence to national PA guidelines. All participants will receive a Fitbit to self-monitor&#xD;
        PA and engage in PA action planning sessions with a study interventionist. In addition,&#xD;
        participants will be randomly assigned to 1 of 4 groups: i) static weekly goal of 150&#xD;
        minutes/week of moderate-intensity PA, which most closely resembles the approach of public&#xD;
        health campaigns and care providers; ii) weekly self-selected PA goals, which allows for&#xD;
        self-determination and adaptation of the goal; iii) modest incremental weekly PA increase&#xD;
        goal (i.e., researcher determined PA goal that 20% minutes/week greater than the minutes/week&#xD;
        of PA in the previous week); or iv) non-goal setting control group. Based on Goal Setting&#xD;
        Theory, it is hypothesized that participants in the incremental goal group will have the&#xD;
        greatest increases in self-regulation and self-efficacy, which in turn, will lead to the&#xD;
        greatest improvements in PA and adherence to national PA guidelines over the 9-month&#xD;
        intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 17, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2027</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>Four arm randomized mechanistic proof-of-concept trial</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Participants will wear wrist-worn ActiGraph GT9X Link Activity monitors the activity monitor on their non-dominant wrist during all waking hours for 7 consecutive days to provide an assessment of usual activity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Fitbit-assessed moderate-to-vigorous intensity physical activity</measure>
      <time_frame>Assessed daily up to 9-months</time_frame>
      <description>Participants will wear a wrist-worn Fitbit activity monitor daily throughout the 9-month intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Self-reported minutes per week of moderate-to-vigorous physical activity assessed by the 7-day Physical Activity Recall.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in physical activity self-regulation from baseline to 6- and 9-months</measure>
      <time_frame>Assessed monthly up to 9-months</time_frame>
      <description>Assessed using the The 12-item Physical Activity Self-Regulation Scale (PASR-12; Umstattd et al., 2009). This scale assess 6 PA-related self-regulatory domains: self-monitoring, goal setting, eliciting social support, reinforcements, time management, relapse prevention. The range of possible scores is 5-60, with higher scores indicating higher levels of physical activity self-regulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in physical activity behavioral strategies from baseline to 6- and 9-months</measure>
      <time_frame>Assessed monthly up to 9-months</time_frame>
      <description>Assessed using 10-item Self-Regulation scale from the Health Belief Survey (Anderson et al., 2010) This scale assesses the use of behavioral strategies to incorporate physical activity into daily activities (i.e., take stairs instead of elevator, walking instead of driving when running errands). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-regulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in physical activity self-efficacy from baseline to 6- and 9-months</measure>
      <time_frame>Assessed monthly up to 9-months</time_frame>
      <description>Assessed by the 12-item Exercise Self-Efficacy survey (Sallis et al.1987). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in general self-regulation from baseline to 6- and 9-months</measure>
      <time_frame>Assessed monthly up to 9-months</time_frame>
      <description>Assessed using the 31-item short version of the self-regulation scale (SSRS; Carey, Neal, &amp; Collins, 2004). The range of possible scores is 31 to 155, with higher scores indicate greater self-regulation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in General Self-Efficacy from baseline to 6- and 9-months</measure>
      <time_frame>Assessed monthly up to 9-months</time_frame>
      <description>Assessed using the 10-item Self-Efficacy Scale publicly available in SOBC repository &amp; NIH Toolbox. The range of possible scores is 31 to 155. Higher scores indicate greater self-efficacy.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in immediate verbal memory from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Assessed using the Auditory Verbal Learning Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in delayed verbal memory from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Assessed using the Delayed Auditory Verbal Learning Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in visual memory from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Assessed using the Picture Sequence Memory Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in executive function from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Assessed using the Dimensional Change Card Sort Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in pattern comparison processing speed from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Assessed using the Pattern Comparison Processing Speed Test. This test asks participants to determine whether two stimuli are the same or not the same as quickly as possible without making mistakes. It is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in processing speed from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Assessed using the Oral Symbol Digit Test. This test assesses time needed to process pairings of digits &amp; symbols and is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in plasma amyloid 42/40 ratio from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Assessed using commercial Meso Scale Discovery (MSD) assays</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in plasma phosphorylated tau 231 from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Assessed using commercial Meso Scale Discovery (MSD) assays</description>
    </other_outcome>
    <other_outcome>
      <measure>Adjudication for Mild Cognitive Impairment (MCI)</measure>
      <time_frame>Performed using data collected at 6-months and 9-months</time_frame>
      <description>Investigator-consensus adjudication will be performed by three investigators to determine if a participant has diagnosable MCI according to the NIA-AA guidelines (Albert et al., 20211).</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in body weight from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Measured in kilograms using an electronic scale</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in BMI from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Calculated using the formula: weight (in kilograms) / height (in meters)^squared</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in blood pressure (mmHG) from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Both systolic and diastolic blood pressure will be assessed using electronic sphygmomanometer following 5-min rest</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in fasting plasma glucose (mg/dL) from baseline to 6- and 9-months</measure>
      <time_frame>baseline, 6-months, 9-months</time_frame>
      <description>Assessed using an automated chemistry analyzer</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in serum lipids (mg/DL) from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in insulin sensitivity (µIU/mL) from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Calculated using homeostatic model assessment (HOMA)</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in depressive symptoms from baseline to 6- and 9-months</measure>
      <time_frame>Assessed at baseline, 6-months, 9-months</time_frame>
      <description>Assessed using the 20-item Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977). This scale has a possible score range 0 to 60, with higher scores indicating greater frequency of depressive symptoms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Protocol Adherence</measure>
      <time_frame>Assessed at 6-months and 9-months</time_frame>
      <description>Number of days Fitbit worn, number of days Fitbit synced, number of weeks study arm specific PA goal met, and number of individual coaching meetings attended.</description>
    </other_outcome>
    <other_outcome>
      <measure>Treatment acceptance</measure>
      <time_frame>Assessed at 6-months and 9-months</time_frame>
      <description>Survey assessing acceptance, feasibility, and consumer satisfaction of intervention.</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">144</enrollment>
    <condition>Physical Activity</condition>
    <condition>Exercise</condition>
    <arm_group>
      <arm_group_label>Static weekly physical activity goal of 150 minutes/week</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a physical activity action planning intervention and assigned a static weekly physical activity goal of 150 minutes/week of moderate-intensity activity; action planning sessions will focus on the participant achieving this weekly goal.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Incremental weekly physical activity goal increase</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a physical activity action planning intervention and assigned a weekly physical activity goal that is 20% greater than the level of moderate-intensity physical activity performed the previous week; action planning sessions will focus on the participant achieving their assigned goal.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Self-selected weekly physical activity goal</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a physical activity action planning intervention and will self-select their own moderate-intensity physical activity goal each week; action planning sessions will focus on helping participants achieve their self-selected goal.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No stated weekly physical activity goal (comparison group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a physical activity action planning intervention that does not include explicitly stated physical activity goals to achieve.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Physical Activity</intervention_name>
      <description>Theory-driven behavioral physical activity promotion intervention.</description>
      <arm_group_label>Incremental weekly physical activity goal increase</arm_group_label>
      <arm_group_label>No stated weekly physical activity goal (comparison group)</arm_group_label>
      <arm_group_label>Self-selected weekly physical activity goal</arm_group_label>
      <arm_group_label>Static weekly physical activity goal of 150 minutes/week</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 45 to 65 years&#xD;
  &#xD;
            -  BMI between 30 kg/m2 to 50 kg/m2&#xD;
  &#xD;
            -  Participants must weigh a minimum of 110 pounds&#xD;
  &#xD;
            -  Engaging in 60 minutes or less of self-reported moderate-to-vigorous physical activity&#xD;
               at screening (based on Exercise Vital Sign Questionnaire)&#xD;
  &#xD;
            -  Self-reported ownership of a smartphone with an iOS or Android operating system&#xD;
               (necessary for participants to track their activity using a Fitbit activity monitor)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a&#xD;
               physician's note is provided&#xD;
  &#xD;
            -  Resting blood pressure greater than 200/110 mmHG as assessed at the baseline study&#xD;
               assessment (unless a physician's note is provided)&#xD;
  &#xD;
            -  Pregnant or planning to become pregnant in next 8-months (Phase 1) or 12 months (Phase&#xD;
               2)&#xD;
  &#xD;
            -  Plans to relocate out of metropolitan Phoenix, Arizona area in the next 8-months&#xD;
               (Phase 1) or 12 months (Phase 2)&#xD;
  &#xD;
            -  Participation in another physical activity, nutrition or weight loss program at time&#xD;
               of screening or at any time during the intervention&#xD;
  &#xD;
            -  Individuals with mild cognitive impairment (MCI), as determined by either a&#xD;
               self-report of receiving a diagnosis of MCI from a health care provider or as assessed&#xD;
               by the Montreal Cognitive Assessment (MoCA) at the study orientation session. A score&#xD;
               &lt; 26 is an exclusion criterion for US born participants. A score of &lt;23 is an&#xD;
               exclusion for participants born outside of the US who completed their high school&#xD;
               education in a country where English is not the primary language.&#xD;
  &#xD;
            -  Being previously prescribed one of the 5 approved Alzheimer's medications, including:&#xD;
               Donepezil (Aricept), Rivastigmine (Exelon), Galantamine (Razadyne), Memantine&#xD;
               (Namenda), Memantine + Donepezil (Namzaric)&#xD;
  &#xD;
            -  Score of 16 or higher on the Center for Epidemiological Studies-Depression Scale&#xD;
               (CES-D)&#xD;
  &#xD;
            -  Self-reported current diagnosis of major depression&#xD;
  &#xD;
            -  Currently taking 2 or more ant-depression drugs&#xD;
  &#xD;
            -  History of stroke&#xD;
  &#xD;
            -  Incarcerated individuals (i.e., Prisoners)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Rodney Joseph, PhD</last_name>
      <phone>602-496-0772</phone>
      <email>rodney.joseph@asu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Molly Maxfield, PhD</last_name>
      <phone>602-496-2311</phone>
      <email>molly.maxfield@asu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Arizona State University</name>
        <address>
          <city>Phoenix</city>
          <state>Arizona</state>
          <zip>85004</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rodney P Joseph</last_name>
        <phone>602-496-0772</phone>
        <email>rodney.joseph@asu.edu</email>
      </contact>
      <investigator>
        <last_name>Rodney P Joseph, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Molly Maxfield, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>exercise</keyword>
    <keyword>physical activity</keyword>
    <keyword>mild cognitive impairment</keyword>
    <keyword>Alzheimer's disease</keyword>
    <keyword>dementia</keyword>
    <keyword>behavior change</keyword>
    <keyword>midlife</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980052
  org study id: STUDY00016394
  secondary id: R61AG078089
  nct id: NCT05980052
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Engaging in regular physical activity during midlife is a key lifestyle behavior associated
        with reduced risk for Alzheimer's disease and related dementias (AD/ADRD). Yet nearly half of
        midlife adults (48%) do not meet national physical activity guidelines. The purpose of this
        mechanistic trial is to identify effective goal setting techniques to enhance psychosocial
        processes of self-regulation for the successful promotion of PA and adherence to national PA
        guidelines among midlife adults, with the long-term goal of reducing AD/ADRD risk
  More than 6 million U.S. adults live with diagnoses of Alzheimer's Disease and Related
        Dementias (AD/ADRD), with projections as high as 13.8 million cases by 2050. There are no
        cures for AD/ADRD, making lifestyle factors key targets for reducing risk, as they account
        for at least a third of AD/ADRD cases. Engaging in regular physical activity (PA),
        particularly in midlife, is associated with reduced risk for AD/ADRD. Yet, nearly half of
        midlife adults (48%) do not meet national PA guidelines of 150 minutes/week of
        moderate-intensity PA. Goal setting is a commonly used behavior change strategy to increase
        PA. Key psychosocial mechanisms believed to underpin the use of goal setting to promote PA
        include self-regulation and self-efficacy. However, the most effective goal setting technique
        to enhance these psychosocial mechanisms for the successful promotion of PA and adherence to
        national PA guidelines remains unclear. In the proposed study, the investigators will use a
        two-phased approach to empirically test three goal setting techniques to enhance psychosocial
        mechanisms of self-regulation and self-efficacy for the successful promotion of PA and
        adherence to national PA guidelines among insufficiently active midlife adults with obesity.
        In the R61 phase, a Phase 1 pilot study will establish feasibility and help refine the
        intervention. In the R33 phase, a Phase 2 9-month 4-arm proof-of-concept mechanistic trial
        (6-month active intervention and 3-month no contact follow-up) will be implemented to
        establish preliminary efficacy of goal setting techniques to increase PA and promote
        adherence to national PA guidelines. All participants will receive a Fitbit to self-monitor
        PA and engage in PA action planning sessions with a study interventionist. In addition,
        participants will be randomly assigned to 1 of 4 groups: i) static weekly goal of 150
        minutes/week of moderate-intensity PA, which most closely resembles the approach of public
        health campaigns and care providers; ii) weekly self-selected PA goals, which allows for
        self-determination and adaptation of the goal; iii) modest incremental weekly PA increase
        goal (i.e., researcher determined PA goal that 20% minutes/week greater than the minutes/week
        of PA in the previous week); or iv) non-goal setting control group. Based on Goal Setting
        Theory, it is hypothesized that participants in the incremental goal group will have the
        greatest increases in self-regulation and self-efficacy, which in turn, will lead to the
        greatest improvements in PA and adherence to national PA guidelines over the 9-month
        intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Four arm randomized mechanistic proof-of-concept trial
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Participants will wear wrist-worn ActiGraph GT9X Link Activity monitors the activity monitor on their non-dominant wrist during all waking hours for 7 consecutive days to provide an assessment of usual activity.
  measure: Change in Fitbit-assessed moderate-to-vigorous intensity physical activity
  time frame: Assessed daily up to 9-months
  description: Participants will wear a wrist-worn Fitbit activity monitor daily throughout the 9-month intervention.
  measure: Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Self-reported minutes per week of moderate-to-vigorous physical activity assessed by the 7-day Physical Activity Recall.
  measure: Change in physical activity self-regulation from baseline to 6- and 9-months
  time frame: Assessed monthly up to 9-months
  description: Assessed using the The 12-item Physical Activity Self-Regulation Scale (PASR-12; Umstattd et al., 2009). This scale assess 6 PA-related self-regulatory domains: self-monitoring, goal setting, eliciting social support, reinforcements, time management, relapse prevention. The range of possible scores is 5-60, with higher scores indicating higher levels of physical activity self-regulation.
  measure: Change in physical activity behavioral strategies from baseline to 6- and 9-months
  time frame: Assessed monthly up to 9-months
  description: Assessed using 10-item Self-Regulation scale from the Health Belief Survey (Anderson et al., 2010) This scale assesses the use of behavioral strategies to incorporate physical activity into daily activities (i.e., take stairs instead of elevator, walking instead of driving when running errands). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-regulation.
  measure: Change in physical activity self-efficacy from baseline to 6- and 9-months
  time frame: Assessed monthly up to 9-months
  description: Assessed by the 12-item Exercise Self-Efficacy survey (Sallis et al.1987). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-efficacy.
  measure: Change in general self-regulation from baseline to 6- and 9-months
  time frame: Assessed monthly up to 9-months
  description: Assessed using the 31-item short version of the self-regulation scale (SSRS; Carey, Neal, & Collins, 2004). The range of possible scores is 31 to 155, with higher scores indicate greater self-regulation
  measure: Change in General Self-Efficacy from baseline to 6- and 9-months
  time frame: Assessed monthly up to 9-months
  description: Assessed using the 10-item Self-Efficacy Scale publicly available in SOBC repository & NIH Toolbox. The range of possible scores is 31 to 155. Higher scores indicate greater self-efficacy.
  measure: Change in immediate verbal memory from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Assessed using the Auditory Verbal Learning Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
  measure: Change in delayed verbal memory from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Assessed using the Delayed Auditory Verbal Learning Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
  measure: Change in visual memory from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Assessed using the Picture Sequence Memory Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
  measure: Change in executive function from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Assessed using the Dimensional Change Card Sort Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
  measure: Change in pattern comparison processing speed from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Assessed using the Pattern Comparison Processing Speed Test. This test asks participants to determine whether two stimuli are the same or not the same as quickly as possible without making mistakes. It is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
  measure: Change in processing speed from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Assessed using the Oral Symbol Digit Test. This test assesses time needed to process pairings of digits & symbols and is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
  measure: Change in plasma amyloid 42/40 ratio from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Assessed using commercial Meso Scale Discovery (MSD) assays
  measure: Change in plasma phosphorylated tau 231 from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Assessed using commercial Meso Scale Discovery (MSD) assays
  measure: Adjudication for Mild Cognitive Impairment (MCI)
  time frame: Performed using data collected at 6-months and 9-months
  description: Investigator-consensus adjudication will be performed by three investigators to determine if a participant has diagnosable MCI according to the NIA-AA guidelines (Albert et al., 20211).
  measure: Change in body weight from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Measured in kilograms using an electronic scale
  measure: Change in BMI from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Calculated using the formula: weight (in kilograms) / height (in meters)^squared
  measure: Change in blood pressure (mmHG) from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Both systolic and diastolic blood pressure will be assessed using electronic sphygmomanometer following 5-min rest
  measure: Change in fasting plasma glucose (mg/dL) from baseline to 6- and 9-months
  time frame: baseline, 6-months, 9-months
  description: Assessed using an automated chemistry analyzer
  measure: Change in serum lipids (mg/DL) from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed
  measure: Change in insulin sensitivity (µIU/mL) from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Calculated using homeostatic model assessment (HOMA)
  measure: Change in depressive symptoms from baseline to 6- and 9-months
  time frame: Assessed at baseline, 6-months, 9-months
  description: Assessed using the 20-item Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977). This scale has a possible score range 0 to 60, with higher scores indicating greater frequency of depressive symptoms.
  measure: Protocol Adherence
  time frame: Assessed at 6-months and 9-months
  description: Number of days Fitbit worn, number of days Fitbit synced, number of weeks study arm specific PA goal met, and number of individual coaching meetings attended.
  measure: Treatment acceptance
  time frame: Assessed at 6-months and 9-months
  description: Survey assessing acceptance, feasibility, and consumer satisfaction of intervention.
  arm group label: Static weekly physical activity goal of 150 minutes/week
  arm group type: Experimental
  description: Participants will receive a physical activity action planning intervention and assigned a static weekly physical activity goal of 150 minutes/week of moderate-intensity activity; action planning sessions will focus on the participant achieving this weekly goal.
  arm group label: Incremental weekly physical activity goal increase
  arm group type: Experimental
  description: Participants will receive a physical activity action planning intervention and assigned a weekly physical activity goal that is 20% greater than the level of moderate-intensity physical activity performed the previous week; action planning sessions will focus on the participant achieving their assigned goal.
  arm group label: Self-selected weekly physical activity goal
  arm group type: Experimental
  description: Participants will receive a physical activity action planning intervention and will self-select their own moderate-intensity physical activity goal each week; action planning sessions will focus on helping participants achieve their self-selected goal.
  arm group label: No stated weekly physical activity goal (comparison group)
  arm group type: Experimental
  description: Participants will receive a physical activity action planning intervention that does not include explicitly stated physical activity goals to achieve.
  intervention type: Behavioral
  intervention name: Physical Activity
  description: Theory-driven behavioral physical activity promotion intervention.
  arm group label: Incremental weekly physical activity goal increase
  arm group label: No stated weekly physical activity goal (comparison group)
  arm group label: Self-selected weekly physical activity goal
  arm group label: Static weekly physical activity goal of 150 minutes/week
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rodney Joseph, PhD
  phone: 602-496-0772
  email: rodney.joseph@asu.edu
  last name: Molly Maxfield, PhD
  phone: 602-496-2311
  email: molly.maxfield@asu.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Undecided