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/NCT06023537</url>
    </required_header>
    <id_info>
      <org_study_id>2023-08</org_study_id>
      <nct_id>NCT06023537</nct_id>
    </id_info>
    <brief_title>Using Technology to Investigate Lapses in a Weight Loss Program Among Individuals With Overweight and Obesity</brief_title>
    <official_title>Using Technology to Investigate Dietary and Physical Activity Lapses in a Behavioral Weight Loss Program</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Williams College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Temple University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Williams College</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>
        Approximately 70% of American adults have overweight/obesity, which increases risk of major&#xD;
        medical issues and preventable death (Abdelaal et. al, 2017). Many individuals with&#xD;
        overweight/obesity attempt to lose weight through behavioral strategies, e.g., adopting a&#xD;
        reduced-calorie diet and/or increased physical activity. However, it is exceedingly difficult&#xD;
        to consistently adhere to a reduced-calorie diet and high levels of physical activity; as&#xD;
        such, most individuals attempting to lose weight via these methods experience repeated&#xD;
        instances of non-adherence, i.e., dietary and physical activity lapses. These lapses are a&#xD;
        core driver of weight loss failure, undermining individuals' ability to achieve weight&#xD;
        control (Forman et al, 2017). As such, it is important to understand what predicts these&#xD;
        lapses, which in turn allows for better lapse prevention. The current study proposes to&#xD;
        measure these risk factors in an ecologically valid manner, i.e., in the moment they occur&#xD;
        and in the context of individuals' everyday lives, using advanced technology. Specifically,&#xD;
        the current study will use ecological momentary assessments (EMA; brief, repeated surveys&#xD;
        delivered in one's natural environment, typically via a smartphone) and sensor technology&#xD;
        (e.g., Fitbit and sensors on smartphone devices) to measure momentary risk factors of dietary&#xD;
        and physical activity lapse, as well as the lapses themselves. Findings from this research&#xD;
        project will lay the groundwork for a sophisticated just-in-time adaptive intervention&#xD;
        (JITAI), a tailored, personalized intervention that targets momentary risk factors (e.g.,&#xD;
        cravings) via in-the-moment support, thereby reducing lapse occurrence and improving&#xD;
        adherence to behavioral weight control prescriptions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 11, 2023</start_date>
    <completion_date type="Anticipated">June 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 10, 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Physical activity lapse/intention-behavior gap</measure>
      <time_frame>up to 12 weeks</time_frame>
      <description>Physical activity lapse/intention-behavior gap will be measured using ecological momentary assessment (EMA; brief, smartphone-delivered surveys) and accelerometers. EMA surveys will be delivered in 2-week bursts at the beginning, middle, and end of treatment. There will be 6 EMA surveys delivered every 2-3 hours throughout the day. Each EMA survey will ask about the participant's intention to engage in moderate-to-vigorous physical activity (MVPA) in the next 2-3 hours and actual engagement in MVPA. Actual MVPA also will be measured through accelerometers (Fitbits). Thus, by measuring intention to engage in MVPA in the next 2-3 hours at Time 1 (e.g., EMA survey at 9:00am) and if the participant actually engaged in MVPA via accelerometer and EMA at Time 2 (2-3 hours later, e.g., at 12:00pm), we can detect a physical activity intention-behavior gap or physical activity lapse.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Dietary lapse</measure>
      <time_frame>up to 12 weeks</time_frame>
      <description>A dietary lapse will be operationalized as exceeding an individualized calorie target for a meal/snack. Specifically, participants will be assigned a reduced-calorie diet to facilitate weight control and each will be prescribed a personalized daily calorie target. That target will then be divvied up into individual calorie targets for 3 meals and 2 snacks daily (e.g., 15% of daily calorie goal allotted for breakfast, 25% for lunch, 40% for dinner, and 10% for each of two snacks). If a participant exceeds one of these meal-specific calorie targets, it is considered a dietary lapse. Participants will log everything they eat and drink in MyFitnessPal, which automatically calculates calories and stores participant's calorie goals for meals/snacks; thus, lapses can be identified when a participant exceeds a calorie target for a meal/snack in MyFitnessPal. Participants also will report dietary lapses via EMA surveys (see above for more information about EMA surveys).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Obesity</condition>
    <condition>Weight Loss</condition>
    <arm_group>
      <arm_group_label>Behavioral Weight Loss Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Behavioral weight loss program</intervention_name>
      <description>All participants will participate in the same remote, behavioral weight loss program. As part of the baseline assessment, participants will be asked to watch a series of custom-made videos on the study's dietary and physical activity prescriptions, dietary self-monitoring, self-weighing, and cognitive-behavioral skills to facilitate engagement in study prescriptions. Participants will be prescribed a reduced-calorie diet that will be individualized based on the individual's starting weight and weight loss goal (recommended goal of 5-10% weight loss over 12 weeks). Participants also will be prescribed a goal of 150 minutes of moderate-to-vigorous physical activity per week. They are also given, free of cost, a Fitbit Charge 5 health tracker, the Fitbit Aria Air digital scale, and a MyFitnessPal Premium subscription for the duration of the study.</description>
      <arm_group_label>Behavioral Weight Loss Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Current BMI = 27-50 kg/m2&#xD;
  &#xD;
            -  Adult (aged 18-65)&#xD;
  &#xD;
            -  Lives in the United States&#xD;
  &#xD;
            -  Possession of a smartphone with a data plan that allows for app data collection&#xD;
  &#xD;
            -  Ability to understand and provide informed consent&#xD;
  &#xD;
            -  Proficiency in speaking, reading, and writing English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presently involved in another weight loss program&#xD;
  &#xD;
            -  Currently pregnant or plan to become pregnant within the study period&#xD;
  &#xD;
            -  Have a medical condition or psychiatric symptoms that: may pose a risk to the&#xD;
               participant during the program; cause a change in weight, appetite, or eating&#xD;
               behavior; or limit ability to comply with the program&#xD;
  &#xD;
            -  Endorse eating disordered behavior, including loss of control (LOC) eating, or the&#xD;
               subjective experience that one cannot control how much food he or she consumes&#xD;
  &#xD;
            -  Have experienced a recent (i.e., within the last 3 months) change in a&#xD;
               weight-influencing medication&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rebecca J Crochiere, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Williams College</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rebecca J Crochiere, PhD</last_name>
      <phone>413-597-2847</phone>
      <email>williamshealthlab@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Health Lab, Psychology Department, Williams College</name>
        <address>
          <city>Williamstown</city>
          <state>Massachusetts</state>
          <zip>01267</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Williams College</investigator_affiliation>
      <investigator_full_name>Rebecca Crochiere</investigator_full_name>
      <investigator_title>Assistant Professor of Psychology</investigator_title>
    </responsible_party>
    <keyword>Obesity</keyword>
    <keyword>Weight Loss</keyword>
    <keyword>Behavioral Treatment</keyword>
    <keyword>Dietary Lapse</keyword>
    <keyword>Physical Activity Lapse</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Body Weight</mesh_term>
      <mesh_term>Weight Loss</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified data and analytic code from this study are available (as allowable according to Institutional Review Board standards) upon reasonable request by emailing the principal investigator.</ipd_description>
    </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/NCT06023537
  org study id: 2023-08
  nct id: NCT06023537
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Approximately 70% of American adults have overweight/obesity, which increases risk of major
        medical issues and preventable death (Abdelaal et. al, 2017). Many individuals with
        overweight/obesity attempt to lose weight through behavioral strategies, e.g., adopting a
        reduced-calorie diet and/or increased physical activity. However, it is exceedingly difficult
        to consistently adhere to a reduced-calorie diet and high levels of physical activity; as
        such, most individuals attempting to lose weight via these methods experience repeated
        instances of non-adherence, i.e., dietary and physical activity lapses. These lapses are a
        core driver of weight loss failure, undermining individuals' ability to achieve weight
        control (Forman et al, 2017). As such, it is important to understand what predicts these
        lapses, which in turn allows for better lapse prevention. The current study proposes to
        measure these risk factors in an ecologically valid manner, i.e., in the moment they occur
        and in the context of individuals' everyday lives, using advanced technology. Specifically,
        the current study will use ecological momentary assessments (EMA; brief, repeated surveys
        delivered in one's natural environment, typically via a smartphone) and sensor technology
        (e.g., Fitbit and sensors on smartphone devices) to measure momentary risk factors of dietary
        and physical activity lapse, as well as the lapses themselves. Findings from this research
        project will lay the groundwork for a sophisticated just-in-time adaptive intervention
        (JITAI), a tailored, personalized intervention that targets momentary risk factors (e.g.,
        cravings) via in-the-moment support, thereby reducing lapse occurrence and improving
        adherence to behavioral weight control prescriptions.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Physical activity lapse/intention-behavior gap
  time frame: up to 12 weeks
  description: Physical activity lapse/intention-behavior gap will be measured using ecological momentary assessment (EMA; brief, smartphone-delivered surveys) and accelerometers. EMA surveys will be delivered in 2-week bursts at the beginning, middle, and end of treatment. There will be 6 EMA surveys delivered every 2-3 hours throughout the day. Each EMA survey will ask about the participant's intention to engage in moderate-to-vigorous physical activity (MVPA) in the next 2-3 hours and actual engagement in MVPA. Actual MVPA also will be measured through accelerometers (Fitbits). Thus, by measuring intention to engage in MVPA in the next 2-3 hours at Time 1 (e.g., EMA survey at 9:00am) and if the participant actually engaged in MVPA via accelerometer and EMA at Time 2 (2-3 hours later, e.g., at 12:00pm), we can detect a physical activity intention-behavior gap or physical activity lapse.
  measure: Dietary lapse
  time frame: up to 12 weeks
  description: A dietary lapse will be operationalized as exceeding an individualized calorie target for a meal/snack. Specifically, participants will be assigned a reduced-calorie diet to facilitate weight control and each will be prescribed a personalized daily calorie target. That target will then be divvied up into individual calorie targets for 3 meals and 2 snacks daily (e.g., 15% of daily calorie goal allotted for breakfast, 25% for lunch, 40% for dinner, and 10% for each of two snacks). If a participant exceeds one of these meal-specific calorie targets, it is considered a dietary lapse. Participants will log everything they eat and drink in MyFitnessPal, which automatically calculates calories and stores participant's calorie goals for meals/snacks; thus, lapses can be identified when a participant exceeds a calorie target for a meal/snack in MyFitnessPal. Participants also will report dietary lapses via EMA surveys (see above for more information about EMA surveys).
  arm group label: Behavioral Weight Loss Intervention
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Behavioral weight loss program
  description: All participants will participate in the same remote, behavioral weight loss program. As part of the baseline assessment, participants will be asked to watch a series of custom-made videos on the study's dietary and physical activity prescriptions, dietary self-monitoring, self-weighing, and cognitive-behavioral skills to facilitate engagement in study prescriptions. Participants will be prescribed a reduced-calorie diet that will be individualized based on the individual's starting weight and weight loss goal (recommended goal of 5-10% weight loss over 12 weeks). Participants also will be prescribed a goal of 150 minutes of moderate-to-vigorous physical activity per week. They are also given, free of cost, a Fitbit Charge 5 health tracker, the Fitbit Aria Air digital scale, and a MyFitnessPal Premium subscription for the duration of the study.
  arm group label: Behavioral Weight Loss Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Rebecca J Crochiere, PhD
  role: Principal Investigator
  affiliation: Williams College
  last name: Rebecca J Crochiere, PhD
  phone: 413-597-2847
  email: williamshealthlab@gmail.com
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Williams College
  investigator full name: Rebecca Crochiere
  investigator title: Assistant Professor of Psychology
  mesh term: Obesity
  mesh term: Body Weight
  mesh term: Weight Loss
  sharing ipd: Yes
  ipd description: De-identified data and analytic code from this study are available (as allowable according to Institutional Review Board standards) upon reasonable request by emailing the principal investigator.