<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/NCT03254953</url>
  </required_header>
  <id_info>
    <org_study_id>D0822</org_study_id>
    <nct_id>NCT03254953</nct_id>
  </id_info>
  <brief_title>GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss</brief_title>
  <official_title>GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss: Does Developing Mastery Before Tracking Diet Enhance Engagement?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke 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>
      This study is a randomized controlled trial that compares 3 self-monitoring approaches for&#xD;
      weight loss. GoalTracker is a standalone, technology-based intervention using a commercial&#xD;
      smartphone app (MyFitnessPal) and email.&#xD;
&#xD;
      The investigators hypothesize that the group that delays diet tracking and receives&#xD;
      additional intervention components (weekly personalized feedback, skills training, and action&#xD;
      plans) will have greater weight loss at the end of the 12-week intervention and at 6-month&#xD;
      followup, compared to (a) an intervention group that simultaneously tracks weight and diet&#xD;
      for all 12 weeks and receives the same additional components, and (b) a control group that&#xD;
      tracks only diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will examine whether a digital health intervention (GoalTracker) can promote&#xD;
      weight loss among adults who are overweight or obese. Engagement in self-monitoring often&#xD;
      declines over time, which is then associated with suboptimal weight loss. Finding ways to&#xD;
      improve self-monitoring engagement, particularly in the first month of treatment, is needed.&#xD;
      Promoting mastery, self-efficacy, and self-regulatory skills may help with maintaining high&#xD;
      engagement.&#xD;
&#xD;
      The investigators aim to enroll 105 participants. All groups are asked to self-monitor daily&#xD;
      on their smartphone using the free commercial mobile application MyFitnessPal over the course&#xD;
      of the 12-week intervention.&#xD;
&#xD;
      Specifically, the study aims to...&#xD;
&#xD;
        1. Determine the effect of a Sequential self-monitoring intervention, compared to a&#xD;
           Simultaneous self-monitoring intervention on weight change, caloric intake change, and&#xD;
           proportion of individuals achieving 5% weight loss.&#xD;
&#xD;
        2. Determine the effect of the Sequential self-monitoring intervention, compared to the&#xD;
           Control, on the same variables.&#xD;
&#xD;
        3. Compare self-monitoring engagement by intervention arm.&#xD;
&#xD;
        4. Examine the relation between self-monitoring engagement and weight loss.&#xD;
&#xD;
        5. Investigate theoretical mediators (self-efficacy, mastery, and self-regulation) on the&#xD;
           relation between treatment arm and weight change.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2017</start_date>
  <completion_date type="Actual">March 2, 2018</completion_date>
  <primary_completion_date type="Actual">December 11, 2017</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>12-week randomized controlled trial to compare 3 self-monitoring approaches for weight loss in a digital health intervention for adults who are overweight or obese</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Weight</measure>
    <time_frame>Baseline, 1 month, 3 months</time_frame>
    <description>Weight will be collected in kilograms using a calibrated digital scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Individuals Achieving ≥ 5% Weight Loss</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Weight will be collected in kilograms using a calibrated digital scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Caloric Intake</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Caloric intake will will be assessed using the Automated Self-Administered 24-hour Dietary Intake Assessment (ASA24), an online dietary recall tool developed by the National Cancer Institute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Weight at 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>At 6-months (i.e., 3 months post-intervention), self-reported weight will be collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Monitoring Engagement</measure>
    <time_frame>Baseline to 1-month and 3 months</time_frame>
    <description>Frequency of self-monitoring weight and diet; Consistency of self-monitoring weight and diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy</measure>
    <time_frame>Baseline, 1 month, 3 months</time_frame>
    <description>Weight Efficacy Lifestyle Questionnaire (WEL) (20 items) will assess self-efficacy for eating. Separate surveys that were adapted will assess self-efficacy for self-monitoring of diet and weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mastery</measure>
    <time_frame>Baseline, 1 month, 3 months</time_frame>
    <description>The Automaticity subscale of The Self-Report Habit Index (SRHI) will assess mastery of self-monitoring diet and weight (4 items each).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Regulation</measure>
    <time_frame>Baseline, 1 month, 3 months</time_frame>
    <description>The Three Factor Eating Questionnaire-R18 (TFEQ-R18) (18 items) will assess self-regulation for controlled eating. Separate surveys that were adapted will assess self-regulation for self-monitoring of diet and weight.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Paffenbarger Activity Questionnaire (7 items) will assess physical activity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>Baseline, 1 month, 3 months</time_frame>
    <description>Medical Outcomes Study (MOS) Sleep (12 items) will assess sleep quality.</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived Stress</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Perceived Stress Scale (10 items)</description>
  </other_outcome>
  <other_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>Baseline, 1 month, 3 months</time_frame>
    <description>Patient Health Questionnaire (PHQ-8) will assess depressive symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Health-Related Quality of Life</measure>
    <time_frame>Baseline, 1 month, 3 months</time_frame>
    <description>EuroQol-5 Dimension (EQ-5D) (5 items) will assess health-related quality of life.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Sequential Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in this Sequential eHealth intervention, participants are asked to self-monitor only their body weight for the first month, then for months 2 and 3 they will be asked to also self-monitor their diet&#xD;
participants are asked to use the MyFitnessPal app for self-monitoring&#xD;
given goal to lose 5% weight by end of intervention (3 months)&#xD;
weekly personalized feedback via email&#xD;
weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email&#xD;
weekly action plans via email</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simultaneous Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in this Simultaneous eHealth intervention, participants are asked to self-monitor both their body weight and diet for 3 months&#xD;
participants are asked to use the MyFitnessPal app for self-monitoring&#xD;
given goal to lose 5% weight by end of intervention (3 months)&#xD;
weekly personalized feedback via email&#xD;
weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email&#xD;
weekly action plans via email</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (diet-tracking only)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>participants are asked to self-monitor their diet for 3 months&#xD;
participants are asked to use the MyFitnessPal app for self-monitoring&#xD;
given goal to lose 5% weight by end of intervention (3 months)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>self-monitoring of body weight</intervention_name>
    <description>- weigh daily for 3 months and track their weight using the MyFitnessPal mobile app</description>
    <arm_group_label>Sequential Intervention</arm_group_label>
    <arm_group_label>Simultaneous Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>self-monitoring of diet</intervention_name>
    <description>track their diet (food and drinks) daily using the MyFitnessPal mobile app&#xD;
when they are asked to track diet will vary based on the arm</description>
    <arm_group_label>Control (diet-tracking only)</arm_group_label>
    <arm_group_label>Sequential Intervention</arm_group_label>
    <arm_group_label>Simultaneous Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>weekly personalized feedback + lessons + action plans</intervention_name>
    <description>- these are additional evidence-based intervention components</description>
    <arm_group_label>Sequential Intervention</arm_group_label>
    <arm_group_label>Simultaneous Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 21-65 years old&#xD;
&#xD;
          -  Body Mass Index (BMI) 25-45 kg/m2&#xD;
&#xD;
          -  interested in losing weight through dietary change&#xD;
&#xD;
          -  current use of iPhone or Android smartphone&#xD;
&#xD;
          -  current use of email address&#xD;
&#xD;
          -  has daily access to a bathroom scale&#xD;
&#xD;
          -  no recent weight loss (≥10 lbs) in the past 6 months&#xD;
&#xD;
          -  able to read and write in English&#xD;
&#xD;
          -  able to attend 3 in-person evaluation visits at Duke University in Durham, North&#xD;
             Carolina over a 3-month period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current participation in another weight loss treatment&#xD;
&#xD;
          -  currently pregnant or planning to become pregnant within study period, or &lt; 1 year&#xD;
             post-partum&#xD;
&#xD;
          -  history of cardiovascular event, eating disorder, diabetes mellitus, hypothyroidism,&#xD;
             cancer, end stage renal disease&#xD;
&#xD;
          -  current uncontrolled hypertension&#xD;
&#xD;
          -  use of the MyFitnessPal app to track food in the past 6 months&#xD;
&#xD;
          -  Former or planned bariatric surgery&#xD;
&#xD;
          -  current use of medication (e.g., lithium, steroids, anti-psychotics)&#xD;
&#xD;
          -  use of weight loss medication in past 6 months&#xD;
&#xD;
          -  profound cognitive, developmental, or psychiatric disorders or recent hospitalization&#xD;
             in a psychiatric facility&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michele G Lanpher, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gary G Bennett, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>April 24, 2018</last_update_submitted>
  <last_update_submitted_qc>April 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>digital health</keyword>
  <keyword>eHealth</keyword>
  <keyword>technology</keyword>
  <keyword>smartphone</keyword>
  <keyword>obesity</keyword>
  <keyword>overweight</keyword>
  <keyword>weight loss</keyword>
  <keyword>behavioral intervention</keyword>
  <keyword>self-monitoring</keyword>
  <keyword>tracking</keyword>
  <keyword>engagement</keyword>
  <keyword>adherence</keyword>
  <keyword>weight change</keyword>
  <keyword>e-mail</keyword>
  <keyword>mobile application</keyword>
  <keyword>goal setting</keyword>
  <keyword>action plan</keyword>
  <keyword>feedback</keyword>
  <keyword>electronic health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This data set is initially being used for the principal investigator's (Michele Lanpher) doctoral dissertation.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03254953
org study id: D0822
nct id: NCT03254953
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized controlled trial that compares 3 self-monitoring approaches for
      weight loss. GoalTracker is a standalone, technology-based intervention using a commercial
      smartphone app (MyFitnessPal) and email.

      The investigators hypothesize that the group that delays diet tracking and receives
      additional intervention components (weekly personalized feedback, skills training, and action
      plans) will have greater weight loss at the end of the 12-week intervention and at 6-month
      followup, compared to (a) an intervention group that simultaneously tracks weight and diet
      for all 12 weeks and receives the same additional components, and (b) a control group that
      tracks only diet.
This study will examine whether a digital health intervention (GoalTracker) can promote
      weight loss among adults who are overweight or obese. Engagement in self-monitoring often
      declines over time, which is then associated with suboptimal weight loss. Finding ways to
      improve self-monitoring engagement, particularly in the first month of treatment, is needed.
      Promoting mastery, self-efficacy, and self-regulatory skills may help with maintaining high
      engagement.

      The investigators aim to enroll 105 participants. All groups are asked to self-monitor daily
      on their smartphone using the free commercial mobile application MyFitnessPal over the course
      of the 12-week intervention.

      Specifically, the study aims to...

        1. Determine the effect of a Sequential self-monitoring intervention, compared to a
           Simultaneous self-monitoring intervention on weight change, caloric intake change, and
           proportion of individuals achieving 5% weight loss.

        2. Determine the effect of the Sequential self-monitoring intervention, compared to the
           Control, on the same variables.

        3. Compare self-monitoring engagement by intervention arm.

        4. Examine the relation between self-monitoring engagement and weight loss.

        5. Investigate theoretical mediators (self-efficacy, mastery, and self-regulation) on the
           relation between treatment arm and weight change.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 12-week randomized controlled trial to compare 3 self-monitoring approaches for weight loss in a digital health intervention for adults who are overweight or obese
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Weight
time frame: Baseline, 1 month, 3 months
description: Weight will be collected in kilograms using a calibrated digital scale
measure: Proportion of Individuals Achieving ≥ 5% Weight Loss
time frame: Baseline to 3 months
description: Weight will be collected in kilograms using a calibrated digital scale
measure: Change in Caloric Intake
time frame: Baseline, 3 months
description: Caloric intake will will be assessed using the Automated Self-Administered 24-hour Dietary Intake Assessment (ASA24), an online dietary recall tool developed by the National Cancer Institute
measure: Change in Weight at 6 Months
time frame: 6 months
description: At 6-months (i.e., 3 months post-intervention), self-reported weight will be collected
measure: Self-Monitoring Engagement
time frame: Baseline to 1-month and 3 months
description: Frequency of self-monitoring weight and diet; Consistency of self-monitoring weight and diet
measure: Self-Efficacy
time frame: Baseline, 1 month, 3 months
description: Weight Efficacy Lifestyle Questionnaire (WEL) (20 items) will assess self-efficacy for eating. Separate surveys that were adapted will assess self-efficacy for self-monitoring of diet and weight.
measure: Mastery
time frame: Baseline, 1 month, 3 months
description: The Automaticity subscale of The Self-Report Habit Index (SRHI) will assess mastery of self-monitoring diet and weight (4 items each).
measure: Self-Regulation
time frame: Baseline, 1 month, 3 months
description: The Three Factor Eating Questionnaire-R18 (TFEQ-R18) (18 items) will assess self-regulation for controlled eating. Separate surveys that were adapted will assess self-regulation for self-monitoring of diet and weight.
measure: Physical Activity
time frame: Baseline, 3 months
description: Paffenbarger Activity Questionnaire (7 items) will assess physical activity.
measure: Sleep Quality
time frame: Baseline, 1 month, 3 months
description: Medical Outcomes Study (MOS) Sleep (12 items) will assess sleep quality.
measure: Perceived Stress
time frame: Baseline, 3 months
description: Perceived Stress Scale (10 items)
measure: Depressive Symptoms
time frame: Baseline, 1 month, 3 months
description: Patient Health Questionnaire (PHQ-8) will assess depressive symptoms.
measure: Health-Related Quality of Life
time frame: Baseline, 1 month, 3 months
description: EuroQol-5 Dimension (EQ-5D) (5 items) will assess health-related quality of life.
arm group label: Sequential Intervention
arm group type: Experimental
description: in this Sequential eHealth intervention, participants are asked to self-monitor only their body weight for the first month, then for months 2 and 3 they will be asked to also self-monitor their diet
participants are asked to use the MyFitnessPal app for self-monitoring
given goal to lose 5% weight by end of intervention (3 months)
weekly personalized feedback via email
weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email
weekly action plans via email
arm group label: Simultaneous Intervention
arm group type: Experimental
description: in this Simultaneous eHealth intervention, participants are asked to self-monitor both their body weight and diet for 3 months
participants are asked to use the MyFitnessPal app for self-monitoring
given goal to lose 5% weight by end of intervention (3 months)
weekly personalized feedback via email
weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email
weekly action plans via email
arm group label: Control (diet-tracking only)
arm group type: Experimental
description: participants are asked to self-monitor their diet for 3 months
participants are asked to use the MyFitnessPal app for self-monitoring
given goal to lose 5% weight by end of intervention (3 months)
intervention type: Behavioral
intervention name: self-monitoring of body weight
description: - weigh daily for 3 months and track their weight using the MyFitnessPal mobile app
arm group label: Sequential Intervention
arm group label: Simultaneous Intervention
intervention type: Behavioral
intervention name: self-monitoring of diet
description: track their diet (food and drinks) daily using the MyFitnessPal mobile app
when they are asked to track diet will vary based on the arm
arm group label: Control (diet-tracking only)
arm group label: Sequential Intervention
arm group label: Simultaneous Intervention
intervention type: Behavioral
intervention name: weekly personalized feedback + lessons + action plans
description: - these are additional evidence-based intervention components
arm group label: Sequential Intervention
arm group label: Simultaneous Intervention
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Michele G Lanpher, MA
role: Principal Investigator
affiliation: Duke University
last name: Gary G Bennett, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
mesh term: Body Weight
mesh term: Weight Loss
sharing ipd: No
ipd description: This data set is initially being used for the principal investigator's (Michele Lanpher) doctoral dissertation.