<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/NCT04505241</url>
  </required_header>
  <id_info>
    <org_study_id>DRX-7861</org_study_id>
    <nct_id>NCT04505241</nct_id>
  </id_info>
  <brief_title>Evaluating Mechanisms of Action of Adaptive Goal-Setting for Physical Activity</brief_title>
  <official_title>Evaluating Mechanisms of Action of Adaptive Goal-Setting for Physical Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Drexel University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Drexel 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>
      Behavior modification programs hold promise for increasing levels of physical activity (PA)&#xD;
      for individuals who are insufficiently active. However, existing interventions, which&#xD;
      typically prescribe uniform PA goals across participants, are limited by their insensitivity&#xD;
      to changing individual needs and circumstances over time. An alternative approach is to&#xD;
      continuously adjust goal difficulty to match fluctuations in individual performance, or&#xD;
      adaptive goal-setting (AGS), which evidence suggests may more effective for increasing PA&#xD;
      than non-adaptive approaches. Still, no prior studies have examined the psychological&#xD;
      mechanisms targeted by AGS, which limits the ability to further refine and disseminate this&#xD;
      technique. In this exploratory study, several candidate mechanisms of AGS (expectancy beliefs&#xD;
      about goals, perceived value of goals, affective appraisal of goals, implicit attitudes&#xD;
      towards exercise) will be examined. Adult participants interested in increasing their level&#xD;
      of physical activity (N = 36) will be randomized to receive 6 weeks of either adaptive&#xD;
      goal-setting (AGS) or non-adaptive, static goal-setting (SGS) as part of a remote,&#xD;
      low-intensity PA intervention. The primary aim of the study will be to evaluate the&#xD;
      hypothesis that AGS, as compared to SGS, results in greater increases over time to four&#xD;
      hypothesized psychological mechanisms. The secondary aim will be to evaluate whether&#xD;
      post-intervention increases to any among these three mechanisms mediate the relationship&#xD;
      between intervention type (AGS vs. SGS) and increases to PA over the course of the&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interested participants will schedule and complete a phone screen with a researcher to&#xD;
      determine eligibility, and if deemed eligible, will complete an initial hour-long baseline&#xD;
      assessment with a member of the study team. The baseline assessment will be conducted over&#xD;
      video call using the secure, easy-to-use and HIPAA-compliant Zoom service hosted by Drexel&#xD;
      University. During the baseline assessment, the assessor will electronically obtain the&#xD;
      participant's informed consent to participate in the study, guide the participant on using a&#xD;
      mobile phone application to track their daily steps (Google Fit), verbally provide&#xD;
      participants with psychoeducational content on safely increasing their physical activity, and&#xD;
      administer a psychological task (Implicit Association Test) as well as questionnaires&#xD;
      (Demographics; Physical Activity Enjoyment Scale; Treatment Self-Regulation Questionnaire;&#xD;
      Self-Efficacy for Exercise Scale). Immediately following the assessment, participants will be&#xD;
      randomized to receive one of two possible remote physical activity interventions: adaptive&#xD;
      goal-setting (AGS) or static goal-setting (SGS). Randomization will follow a stratified&#xD;
      procedure based on age (cutoff point = 45 years), and permuted block randomization will be&#xD;
      used within strata to assign individuals to an intervention condition (AGS or SGS). Both&#xD;
      interventions will be preceded by a 10-day baseline &quot;run-in&quot; period during which participants&#xD;
      will be asked to record their activity but will not receive any daily step goals. In&#xD;
      addition, in both interventions, a brief (10-minute) mid-study (3-week) check-in call will be&#xD;
      conducted with each participant by a member of the study team to encourage continued&#xD;
      compliance with step goals and problem-solve any barriers to increasing physical activity.&#xD;
      Participants will also complete a brief survey once each week over the course of the&#xD;
      intervention period. At the conclusion of the intervention period, participants will complete&#xD;
      several post-intervention questionnaires/tasks and will then be compensated for their&#xD;
      participation.&#xD;
&#xD;
      Participants in the adaptive goal-setting condition will begin receiving a new step goal each&#xD;
      day over text message (SMS) following the baseline run-in period (starting Week 2). These&#xD;
      messages will continue to be delivered each day for the entire duration of the 6-week&#xD;
      intervention period (through Week 8), and will contain information about the participant's&#xD;
      daily-assigned step goal as well as their number of steps on the previous day in reference to&#xD;
      their previous day's goal. Goals will be calculated using a 60th percentile method&#xD;
      (consistent with prior research on adaptive goal-setting), such that each day's goal will be&#xD;
      set to the 60th percentile value of the last 9 days of available step data for that&#xD;
      participant. Goals will be calculated by an algorithm stored on a remote database that&#xD;
      automatically extracts user data from the Google Fit cloud server (Google Fitness Store). The&#xD;
      database will store daily steps data for each participant, use these data to calculate new&#xD;
      daily step goals and transmit them over SMS using a commercial cloud communications platform.&#xD;
      The maximum steps goal permitted by the algorithm will be 20,000 steps/day, to ensure that&#xD;
      goals remain within an attainable range for most individuals. Participants in the static&#xD;
      goal-setting condition will receive the same exact step goal each day (10,000 steps),&#xD;
      consistent with prior research, and will receive daily text message updates providing a&#xD;
      summary of their previous day's steps and encouraging them to reach their 10,000-step goal&#xD;
      for that day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">February 1, 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>Half of participants will be randomized to receive text message-delivered adaptive goal-setting (goals change each day) for 6 weeks, and half will receive static goal-setting (goals are fixed) for 6 weeks.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Participants will not be informed of their assigned condition, though may infer it through the types of texts that they receive.&#xD;
The principal investigator and outcomes assessor will each be blinded to a participant's assignment while the participant is enrolled in the study, and will be unblinded at the conclusion of the study prior to performing statistical analyses.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change to Week 3 Expectancy Beliefs about Goals at Week 7</measure>
    <time_frame>Measured once weekly from Week 3 through Week 7</time_frame>
    <description>Expectations about one's own ability to achieve physical activity goals will be assessed weekly using a single Likert scale derived from prior research on Expectancy-Values Theories (EVT) of achievement motivation. Responses on the scale will range from 1-5, with higher values representing higher expectations about one's ability to achieve daily activity goals.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change to Week 3 Affective Appraisals of Goals at Week 7</measure>
    <time_frame>Measured once weekly from Week 3 through Week 7</time_frame>
    <description>Appraisals of daily physical activity goals will assessed weekly using a single Likert scale item asking participants to rate their emotional reactions to daily goals on a scale from 1 (Most Negative) to 10 (Most Positive).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change to Week 3 Perceived Value of Goals at Week 7</measure>
    <time_frame>Measured once weekly from Week 3 through Week 7</time_frame>
    <description>Perceived Value of Goals corresponds to the value or importance that an individual attributes to assigned activity goals, and will be assessed weekly using four items derived from Expectancy-Value Theory (EVT) questionnaires (attainment value; interest value; utility value; cost). All items will be measured on a 1-5 Likert scale where higher scores represent higher perceived value, and the mean of all four items will be used to generate an overall Perceived Value score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change to Baseline Implicit Attitudes Towards Exercise at Week 8</measure>
    <time_frame>Measured at Week 0 (baseline) and Week 8 (post-intervention)</time_frame>
    <description>Implicit attitudes towards exercise will be measured using an Implicit Association Test (IAT) tailored to examine attitudes towards exercise. Image and text stimuli will be closely adapted from prior IAT research in the domain of exercise, with &quot;Exercise&quot; vs. &quot;Not Exercise&quot; serving as the concept dimension and &quot;Pleasant&quot; vs. &quot;Unpleasant&quot; serving as the attribute dimension. A difference score (d-score) will be computed for each participant, with more positive scores indicating more favorable implicit attitudes towards exercise.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change to Baseline Self-efficacy for Exercise at Week 8</measure>
    <time_frame>Measured at Week 0 (baseline) and Week 8 (post-intervention)</time_frame>
    <description>Self-efficacy regarding one's ability to exercise will be examined using the Self-Efficacy for Exercise (SEE) questionnaire. This 9-item questionnaire assesses an individual's confidence in their ability to exercise when faced with a variety of barriers (e.g., fatigue, discomfort, lack of time). Items are rated on a 0-10 scale, with higher scores representing greater self-efficacy about one's ability to exercise. Scores for each item are averaged to compute an overall self-efficacy score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change to Baseline Physical Activity Enjoyment at Week 8</measure>
    <time_frame>Measured at Week 0 (baseline) and Week 8 (post-intervention)</time_frame>
    <description>Enjoyment of physical activity will be assessed using the Physical Activity Enjoyment Scale (PACES) is an 18-item measure that evaluates enjoyment of various facets of physical activity on a 7-point bipolar Likert scale, with higher scores indicating greater enjoyment of exercise. Scores for each item are averaged to compute an overall physical activity enjoyment score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change to Autonomous Motivation to Exercise at Week 8</measure>
    <time_frame>Measured at Week 0 (baseline) and Week 8 (post-intervention)</time_frame>
    <description>Autonomous motivation to exercise will be assessed using the Treatment Self-Regulation Questionnaire (TSRQ), which is a 15-item measure examines several facets of motivation to engage in health behaviors as conceptualized by self-determination theory. Responses are rated on a Likert scale (0 = not at all true, 7 = very true) and averaged across items to compute individual subscale scores (autonomous, external, introjected, identified, amotivation). The current study will focus primarily on the Autonomous Motivation subscale, which assesses an individual's intrinsic reasons for engaging in health behaviors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change to Baseline Daily Levels of Physical Activity at Week 8</measure>
    <time_frame>Measured at Week 0 (baseline) and Week 8 (post-intervention)</time_frame>
    <description>Daily level of physical activity will be measured as the number of steps that a participant records each day using their smartphone pedometers. Daily steps data collected over the full duration intervention phase will be automatically transferred via Google Fit to a remote database where they will be stored and later analyzed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Motivation</condition>
  <condition>Physical Activity Promotion</condition>
  <condition>Behavior Change</condition>
  <condition>Mobile Health</condition>
  <arm_group>
    <arm_group_label>Adaptive Goal-Setting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition will receive daily step goals calculated as the 60th percentile of their last 9 days of available daily steps data. Goals will be transmitted over text message, and will be accompanied by information about the participant's steps on the previous day and whether they met their goal the previous day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Static Goal-Setting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition will receive daily a uniform daily goal of 10,000 steps per day. Participants will receive daily texts including information about the participant's steps on the previous day, whether they met their goal the previous day, and encouraging them to continue striving for 10,000 steps each day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Remotely-delivered physical activity promotion</intervention_name>
    <description>Over video-call, participants will receive educational content on safely increasing their levels of physical activity (e.g., selecting an appropriate form of exercise, minimizing health risks, the importance of planning), will receive daily text messages (see arm descriptions) for six weeks and complete a 10-15 minute check-in call at the 3-week point of the intervention to assess compliance with daily step goals as well as to help problem-solve barriers to compliance.</description>
    <arm_group_label>Adaptive Goal-Setting</arm_group_label>
    <arm_group_label>Static Goal-Setting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18-75 years old&#xD;
&#xD;
          2. Reporting a desire to increase physical activity in order to lose weight, prevent&#xD;
             weight gain or improve physical health&#xD;
&#xD;
          3. Possessing a smartphone that can connect to a WiFi (wireless fidelity) network&#xD;
&#xD;
          4. Daily access to a WiFi connection&#xD;
&#xD;
          5. Ability to understand and provide informed consent&#xD;
&#xD;
          6. Proficiency in speaking, reading, and writing English&#xD;
&#xD;
          7. Currently report engaging in insufficient levels of physical activity (&lt;150&#xD;
             minutes/week of moderate-to-vigorous physical activity)&#xD;
&#xD;
        Exclusion Criteria;&#xD;
&#xD;
          1. Present involvement in another physical activity promotion or a behavioral weight loss&#xD;
             program&#xD;
&#xD;
          2. Pregnant or planning to become pregnant within the next 6 months (exclude for either)&#xD;
&#xD;
          3. Current BMI &lt;18.5 kg/m^2&#xD;
&#xD;
          4. Diagnosis of a medical condition that could limit the ability to increase physical&#xD;
             activity&#xD;
&#xD;
          5. Acute suicide risk (exclude if present in the past 2 weeks or if any attempts were&#xD;
             made in past 2 years)&#xD;
&#xD;
          6. Current substance use disorder&#xD;
&#xD;
          7. Current diagnosis of psychosis&#xD;
&#xD;
          8. Current diagnosis of bipolar disorder&#xD;
&#xD;
          9. Currently meet criteria for loss-of-control eating&#xD;
&#xD;
         10. Presence of compensatory behaviors (vomiting, laxatives, diuretics, exercise)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Drexel University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>April 10, 2021</last_update_submitted>
  <last_update_submitted_qc>April 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Drexel University</investigator_affiliation>
    <investigator_full_name>Evan Forman</investigator_full_name>
    <investigator_title>Professor of Psychology</investigator_title>
  </responsible_party>
  <keyword>Physical Activity</keyword>
  <keyword>Goal-Setting</keyword>
  <keyword>Adaptive Interventions</keyword>
  <keyword>Health-Related Behavior Change</keyword>
  <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/NCT04505241
org study id: DRX-7861
nct id: NCT04505241
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Behavior modification programs hold promise for increasing levels of physical activity (PA)
      for individuals who are insufficiently active. However, existing interventions, which
      typically prescribe uniform PA goals across participants, are limited by their insensitivity
      to changing individual needs and circumstances over time. An alternative approach is to
      continuously adjust goal difficulty to match fluctuations in individual performance, or
      adaptive goal-setting (AGS), which evidence suggests may more effective for increasing PA
      than non-adaptive approaches. Still, no prior studies have examined the psychological
      mechanisms targeted by AGS, which limits the ability to further refine and disseminate this
      technique. In this exploratory study, several candidate mechanisms of AGS (expectancy beliefs
      about goals, perceived value of goals, affective appraisal of goals, implicit attitudes
      towards exercise) will be examined. Adult participants interested in increasing their level
      of physical activity (N = 36) will be randomized to receive 6 weeks of either adaptive
      goal-setting (AGS) or non-adaptive, static goal-setting (SGS) as part of a remote,
      low-intensity PA intervention. The primary aim of the study will be to evaluate the
      hypothesis that AGS, as compared to SGS, results in greater increases over time to four
      hypothesized psychological mechanisms. The secondary aim will be to evaluate whether
      post-intervention increases to any among these three mechanisms mediate the relationship
      between intervention type (AGS vs. SGS) and increases to PA over the course of the
      intervention.
Interested participants will schedule and complete a phone screen with a researcher to
      determine eligibility, and if deemed eligible, will complete an initial hour-long baseline
      assessment with a member of the study team. The baseline assessment will be conducted over
      video call using the secure, easy-to-use and HIPAA-compliant Zoom service hosted by Drexel
      University. During the baseline assessment, the assessor will electronically obtain the
      participant's informed consent to participate in the study, guide the participant on using a
      mobile phone application to track their daily steps (Google Fit), verbally provide
      participants with psychoeducational content on safely increasing their physical activity, and
      administer a psychological task (Implicit Association Test) as well as questionnaires
      (Demographics; Physical Activity Enjoyment Scale; Treatment Self-Regulation Questionnaire;
      Self-Efficacy for Exercise Scale). Immediately following the assessment, participants will be
      randomized to receive one of two possible remote physical activity interventions: adaptive
      goal-setting (AGS) or static goal-setting (SGS). Randomization will follow a stratified
      procedure based on age (cutoff point = 45 years), and permuted block randomization will be
      used within strata to assign individuals to an intervention condition (AGS or SGS). Both
      interventions will be preceded by a 10-day baseline "run-in" period during which participants
      will be asked to record their activity but will not receive any daily step goals. In
      addition, in both interventions, a brief (10-minute) mid-study (3-week) check-in call will be
      conducted with each participant by a member of the study team to encourage continued
      compliance with step goals and problem-solve any barriers to increasing physical activity.
      Participants will also complete a brief survey once each week over the course of the
      intervention period. At the conclusion of the intervention period, participants will complete
      several post-intervention questionnaires/tasks and will then be compensated for their
      participation.

      Participants in the adaptive goal-setting condition will begin receiving a new step goal each
      day over text message (SMS) following the baseline run-in period (starting Week 2). These
      messages will continue to be delivered each day for the entire duration of the 6-week
      intervention period (through Week 8), and will contain information about the participant's
      daily-assigned step goal as well as their number of steps on the previous day in reference to
      their previous day's goal. Goals will be calculated using a 60th percentile method
      (consistent with prior research on adaptive goal-setting), such that each day's goal will be
      set to the 60th percentile value of the last 9 days of available step data for that
      participant. Goals will be calculated by an algorithm stored on a remote database that
      automatically extracts user data from the Google Fit cloud server (Google Fitness Store). The
      database will store daily steps data for each participant, use these data to calculate new
      daily step goals and transmit them over SMS using a commercial cloud communications platform.
      The maximum steps goal permitted by the algorithm will be 20,000 steps/day, to ensure that
      goals remain within an attainable range for most individuals. Participants in the static
      goal-setting condition will receive the same exact step goal each day (10,000 steps),
      consistent with prior research, and will receive daily text message updates providing a
      summary of their previous day's steps and encouraging them to reach their 10,000-step goal
      for that day.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Half of participants will be randomized to receive text message-delivered adaptive goal-setting (goals change each day) for 6 weeks, and half will receive static goal-setting (goals are fixed) for 6 weeks.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Participants will not be informed of their assigned condition, though may infer it through the types of texts that they receive.
The principal investigator and outcomes assessor will each be blinded to a participant's assignment while the participant is enrolled in the study, and will be unblinded at the conclusion of the study prior to performing statistical analyses.
measure: Change to Week 3 Expectancy Beliefs about Goals at Week 7
time frame: Measured once weekly from Week 3 through Week 7
description: Expectations about one's own ability to achieve physical activity goals will be assessed weekly using a single Likert scale derived from prior research on Expectancy-Values Theories (EVT) of achievement motivation. Responses on the scale will range from 1-5, with higher values representing higher expectations about one's ability to achieve daily activity goals.
measure: Change to Week 3 Affective Appraisals of Goals at Week 7
time frame: Measured once weekly from Week 3 through Week 7
description: Appraisals of daily physical activity goals will assessed weekly using a single Likert scale item asking participants to rate their emotional reactions to daily goals on a scale from 1 (Most Negative) to 10 (Most Positive).
measure: Change to Week 3 Perceived Value of Goals at Week 7
time frame: Measured once weekly from Week 3 through Week 7
description: Perceived Value of Goals corresponds to the value or importance that an individual attributes to assigned activity goals, and will be assessed weekly using four items derived from Expectancy-Value Theory (EVT) questionnaires (attainment value; interest value; utility value; cost). All items will be measured on a 1-5 Likert scale where higher scores represent higher perceived value, and the mean of all four items will be used to generate an overall Perceived Value score.
measure: Change to Baseline Implicit Attitudes Towards Exercise at Week 8
time frame: Measured at Week 0 (baseline) and Week 8 (post-intervention)
description: Implicit attitudes towards exercise will be measured using an Implicit Association Test (IAT) tailored to examine attitudes towards exercise. Image and text stimuli will be closely adapted from prior IAT research in the domain of exercise, with "Exercise" vs. "Not Exercise" serving as the concept dimension and "Pleasant" vs. "Unpleasant" serving as the attribute dimension. A difference score (d-score) will be computed for each participant, with more positive scores indicating more favorable implicit attitudes towards exercise.
measure: Change to Baseline Self-efficacy for Exercise at Week 8
time frame: Measured at Week 0 (baseline) and Week 8 (post-intervention)
description: Self-efficacy regarding one's ability to exercise will be examined using the Self-Efficacy for Exercise (SEE) questionnaire. This 9-item questionnaire assesses an individual's confidence in their ability to exercise when faced with a variety of barriers (e.g., fatigue, discomfort, lack of time). Items are rated on a 0-10 scale, with higher scores representing greater self-efficacy about one's ability to exercise. Scores for each item are averaged to compute an overall self-efficacy score.
measure: Change to Baseline Physical Activity Enjoyment at Week 8
time frame: Measured at Week 0 (baseline) and Week 8 (post-intervention)
description: Enjoyment of physical activity will be assessed using the Physical Activity Enjoyment Scale (PACES) is an 18-item measure that evaluates enjoyment of various facets of physical activity on a 7-point bipolar Likert scale, with higher scores indicating greater enjoyment of exercise. Scores for each item are averaged to compute an overall physical activity enjoyment score.
measure: Change to Autonomous Motivation to Exercise at Week 8
time frame: Measured at Week 0 (baseline) and Week 8 (post-intervention)
description: Autonomous motivation to exercise will be assessed using the Treatment Self-Regulation Questionnaire (TSRQ), which is a 15-item measure examines several facets of motivation to engage in health behaviors as conceptualized by self-determination theory. Responses are rated on a Likert scale (0 = not at all true, 7 = very true) and averaged across items to compute individual subscale scores (autonomous, external, introjected, identified, amotivation). The current study will focus primarily on the Autonomous Motivation subscale, which assesses an individual's intrinsic reasons for engaging in health behaviors.
measure: Change to Baseline Daily Levels of Physical Activity at Week 8
time frame: Measured at Week 0 (baseline) and Week 8 (post-intervention)
description: Daily level of physical activity will be measured as the number of steps that a participant records each day using their smartphone pedometers. Daily steps data collected over the full duration intervention phase will be automatically transferred via Google Fit to a remote database where they will be stored and later analyzed.
arm group label: Adaptive Goal-Setting
arm group type: Experimental
description: Participants in this condition will receive daily step goals calculated as the 60th percentile of their last 9 days of available daily steps data. Goals will be transmitted over text message, and will be accompanied by information about the participant's steps on the previous day and whether they met their goal the previous day.
arm group label: Static Goal-Setting
arm group type: Experimental
description: Participants in this condition will receive daily a uniform daily goal of 10,000 steps per day. Participants will receive daily texts including information about the participant's steps on the previous day, whether they met their goal the previous day, and encouraging them to continue striving for 10,000 steps each day.
intervention type: Behavioral
intervention name: Remotely-delivered physical activity promotion
description: Over video-call, participants will receive educational content on safely increasing their levels of physical activity (e.g., selecting an appropriate form of exercise, minimizing health risks, the importance of planning), will receive daily text messages (see arm descriptions) for six weeks and complete a 10-15 minute check-in call at the 3-week point of the intervention to assess compliance with daily step goals as well as to help problem-solve barriers to compliance.
arm group label: Adaptive Goal-Setting
arm group label: Static Goal-Setting
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Drexel University
investigator full name: Evan Forman
investigator title: Professor of Psychology
sharing ipd: No