<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/NCT03836391</url>
  </required_header>
  <id_info>
    <org_study_id>16-0775</org_study_id>
    <nct_id>NCT03836391</nct_id>
  </id_info>
  <brief_title>Precision Public Health: Enhancing Connections to Develop Just-in-Time Adaptive Intervention Strategies</brief_title>
  <acronym>Nudge</acronym>
  <official_title>Precision Public Health: Enhancing Connections to Develop Just-in-Time Adaptive Intervention Strategies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study is to examine the effects of different types of just-in-time&#xD;
      intervention messages on daily meeting dietary, activity, and weighing goals in a sample of&#xD;
      young adults participating in a mobile-based weight loss program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Public health interventions typically rely on a set schedule of intervention delivery.&#xD;
      Advances in technology and computer tailoring allow us to go from a &quot;one size fits all&quot;&#xD;
      approach to one that uses digital health data to deliver &quot;just-in-time adaptive&#xD;
      interventions,&quot; or JITAIs, that can vary the timing, dose, and content of intervention&#xD;
      messages to individuals. This pilot study is a micro-randomized trial that evaluates the&#xD;
      effects of various intervention message options delivered in JIT moments on meeting dietary,&#xD;
      activity, and weighing goals among young adults in a mobile-based weight loss program.&#xD;
&#xD;
      The Nudge study is a 12-week mobile health weight loss program delivered via a native&#xD;
      smartphone application. Individuals are asked to track their red foods (high-calorie,&#xD;
      high-fat foods) in the app daily and meet their personalized red foods goal, wear a Fitbit&#xD;
      daily and meet their daily active minutes goal, and weigh daily on their WiFi-enabled scale.&#xD;
      Up to 4 times each day, participants are randomized to receive or not receive intervention&#xD;
      messages in order to examine the effects of these intervention message types on meeting daily&#xD;
      weighing goals, red food goals, and activity goals. This is a within-subjects design in which&#xD;
      each participant serves as their own control, and data is analyzed at the person-day level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">September 16, 2019</completion_date>
  <primary_completion_date type="Actual">September 16, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Each participant-time point is randomized between intervention message or no intervention message</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of person-days with same-day weighing</measure>
    <time_frame>from Baseline to Week 12</time_frame>
    <description>Percent who weighed after the message randomization time until the end of the day (at the participant-day level) across the 12-week study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of person-days with next-day weighing</measure>
    <time_frame>from Baseline to Week 12</time_frame>
    <description>Percent who weighed the day after the message randomization (at the participant-day level) across the 12-week study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of person-days met active minutes goal on same day</measure>
    <time_frame>from Baseline to Week 12</time_frame>
    <description>Percent who met active minutes goal after the message randomization time until the end of the day (at the participant-day level) across the 12-week study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of person-days met active minutes goal on next day</measure>
    <time_frame>from Baseline to Week 12</time_frame>
    <description>Percent who met active minutes goal the day after the message randomization (at the participant-day level) across the 12-week study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of person-days met red foods goal on same day</measure>
    <time_frame>from Baseline to Week 12</time_frame>
    <description>Percent who met red foods goal after the message randomization time until the end of the day (at the participant-day level) across the 12-week study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of person-days met red foods goal on next day</measure>
    <time_frame>from Baseline to Week 12</time_frame>
    <description>Percent who met red foods goal the day after the message randomization (at the participant-day level) across the 12-week study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of active minutes</measure>
    <time_frame>from Baseline to Week 12</time_frame>
    <description>Total number of active minutes on the day of message randomization (at the participant-day level) across the 12-week study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proximal effect of message on total red foods today</measure>
    <time_frame>from Baseline to Week 12</time_frame>
    <description>Total number of red foods on the day of message randomization (at the participant-day level) across the 12-week study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean weight change</measure>
    <time_frame>from Baseline to Week 12</time_frame>
    <description>Mean weight change across participants</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Nudge Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each of 7 intervention message options has specific decision rules (including weighed/not weighed and progress toward daily dietary and activity goals) that make a participant eligible to receive a specific intervention type at a specific time (decision points).&#xD;
At each decision point (early morning, morning, midday, and evening), the system evaluates which intervention options a participant is eligible to receive, and randomly chooses one intervention option from that list. Then the participant is randomly assigned to either receive or not receive that intervention message (with a 50-50 probability).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nudge</intervention_name>
    <description>Nudge is a smartphone-app-based micro-randomized trial that tests the effect of 7 intervention message types based on behavior change techniques on daily goal attainment. Participants have three daily goals: weigh daily, red foods goal, and active minutes goal.</description>
    <arm_group_label>Nudge Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-35&#xD;
&#xD;
          -  BMI of 25-40 kg/m²&#xD;
&#xD;
          -  Not adhering to the US physical activity guidelines of at least 150&#xD;
             moderate-to-vigorous intensity activity minutes/week&#xD;
&#xD;
          -  English-speaking and writing&#xD;
&#xD;
          -  No pre-existing medical condition(s) that preclude adherence to an unsupervised&#xD;
             exercise program, diabetes treated with insulin, history of heart attack or stroke,&#xD;
             current treatment for cancer, or inability to walk for exercise&#xD;
&#xD;
          -  Has an iPhone with iOS 11 (or willing to download it) with internet access and text&#xD;
             messaging plan&#xD;
&#xD;
          -  Has home wireless access compatible with Fitbit Aria 2 scale (802.11b/g/n)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current participation in another physical activity or weight control program&#xD;
&#xD;
          -  Currently pregnant, pregnant in last 6 months, or planning pregnancy in next 3 months&#xD;
&#xD;
          -  Report a heart condition, chest pain during periods of activity or rest, loss of&#xD;
             consciousness, joint or bone problems, or prescription medicine usage for blood&#xD;
             pressure or heart condition on the Physical Activity Readiness Questionnaire (PAR-Q)&#xD;
&#xD;
          -  Health or psychological diagnoses that preclude participation in a prescribed dietary&#xD;
             and exercise program, including diagnosis of schizophrenia or bipolar disorder,&#xD;
             hospitalization for a psychiatric diagnosis in the past year, diagnosis of alcohol or&#xD;
             substance abuse&#xD;
&#xD;
          -  Occupation requires primarily night shift work&#xD;
&#xD;
          -  Owns and uses a physical activity tracker&#xD;
&#xD;
          -  Moving out of area in next 4 months&#xD;
&#xD;
          -  Out of town for a week or more during study period&#xD;
&#xD;
          -  Not willing to attend two study visits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deborah F Tate, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carmina G Valle, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Health Behavior, University of North Carolina, Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>November 11, 2019</last_update_submitted>
  <last_update_submitted_qc>November 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mobile health</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Self-monitoring</keyword>
  <keyword>Smartphone app</keyword>
  <keyword>Digital health tools</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</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/NCT03836391
org study id: 16-0775
nct id: NCT03836391
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this pilot study is to examine the effects of different types of just-in-time
      intervention messages on daily meeting dietary, activity, and weighing goals in a sample of
      young adults participating in a mobile-based weight loss program.
Public health interventions typically rely on a set schedule of intervention delivery.
      Advances in technology and computer tailoring allow us to go from a "one size fits all"
      approach to one that uses digital health data to deliver "just-in-time adaptive
      interventions," or JITAIs, that can vary the timing, dose, and content of intervention
      messages to individuals. This pilot study is a micro-randomized trial that evaluates the
      effects of various intervention message options delivered in JIT moments on meeting dietary,
      activity, and weighing goals among young adults in a mobile-based weight loss program.

      The Nudge study is a 12-week mobile health weight loss program delivered via a native
      smartphone application. Individuals are asked to track their red foods (high-calorie,
      high-fat foods) in the app daily and meet their personalized red foods goal, wear a Fitbit
      daily and meet their daily active minutes goal, and weigh daily on their WiFi-enabled scale.
      Up to 4 times each day, participants are randomized to receive or not receive intervention
      messages in order to examine the effects of these intervention message types on meeting daily
      weighing goals, red food goals, and activity goals. This is a within-subjects design in which
      each participant serves as their own control, and data is analyzed at the person-day level.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Each participant-time point is randomized between intervention message or no intervention message
primary purpose: Treatment
masking: None (Open Label)
measure: Percent of person-days with same-day weighing
time frame: from Baseline to Week 12
description: Percent who weighed after the message randomization time until the end of the day (at the participant-day level) across the 12-week study
measure: Percent of person-days with next-day weighing
time frame: from Baseline to Week 12
description: Percent who weighed the day after the message randomization (at the participant-day level) across the 12-week study
measure: Percent of person-days met active minutes goal on same day
time frame: from Baseline to Week 12
description: Percent who met active minutes goal after the message randomization time until the end of the day (at the participant-day level) across the 12-week study
measure: Percent of person-days met active minutes goal on next day
time frame: from Baseline to Week 12
description: Percent who met active minutes goal the day after the message randomization (at the participant-day level) across the 12-week study
measure: Percent of person-days met red foods goal on same day
time frame: from Baseline to Week 12
description: Percent who met red foods goal after the message randomization time until the end of the day (at the participant-day level) across the 12-week study
measure: Percent of person-days met red foods goal on next day
time frame: from Baseline to Week 12
description: Percent who met red foods goal the day after the message randomization (at the participant-day level) across the 12-week study
measure: Number of active minutes
time frame: from Baseline to Week 12
description: Total number of active minutes on the day of message randomization (at the participant-day level) across the 12-week study
measure: Proximal effect of message on total red foods today
time frame: from Baseline to Week 12
description: Total number of red foods on the day of message randomization (at the participant-day level) across the 12-week study
measure: Mean weight change
time frame: from Baseline to Week 12
description: Mean weight change across participants
arm group label: Nudge Intervention
arm group type: Experimental
description: Each of 7 intervention message options has specific decision rules (including weighed/not weighed and progress toward daily dietary and activity goals) that make a participant eligible to receive a specific intervention type at a specific time (decision points).
At each decision point (early morning, morning, midday, and evening), the system evaluates which intervention options a participant is eligible to receive, and randomly chooses one intervention option from that list. Then the participant is randomly assigned to either receive or not receive that intervention message (with a 50-50 probability).
intervention type: Behavioral
intervention name: Nudge
description: Nudge is a smartphone-app-based micro-randomized trial that tests the effect of 7 intervention message types based on behavior change techniques on daily goal attainment. Participants have three daily goals: weigh daily, red foods goal, and active minutes goal.
arm group label: Nudge Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Deborah F Tate, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Carmina G Valle, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
sharing ipd: No