<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/NCT03273491</url>
  </required_header>
  <id_info>
    <org_study_id>17A00813</org_study_id>
    <nct_id>NCT03273491</nct_id>
  </id_info>
  <brief_title>Self-Weighing: an Ecological Momentary Assessment</brief_title>
  <acronym>SWEMA</acronym>
  <official_title>Self-weighing's Psychological Effects: a Randomized Controlled Trial Using Ecological Momentary Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Delaware</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Delaware</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 primary objective of this study is to experimentally test the momentary and more distal&#xD;
      psychological effects of daily self weighing as compared to an active control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two significant public health problems, obesity and eating disorders, are prevalent during&#xD;
      emerging adulthood, a unique stage of life between ages 18 and 25. Over half of emerging&#xD;
      adults experience weight gain and/or disordered eating (e.g. overly restrictive dieting,&#xD;
      binge eating); both of which contribute to obesity. Because many emerging adults attend&#xD;
      college, the college community represents a viable population for implementing interventions&#xD;
      to prevent weight gain, while not triggering disordered eating.&#xD;
&#xD;
      A promising strategy for preventing weight gain during college is daily self-weighing, an&#xD;
      example of behavioral self-monitoring, an evidence-based strategy for weight control.&#xD;
      Self-monitoring is fundamental to behavior change: feedback allows the user to evaluate&#xD;
      progress in relation to a goal and modify behavior. Despite self-monitoring being&#xD;
      recommended, some evidence suggests that self-monitoring strategies, self-weighing in&#xD;
      particular, may have unintended psychological consequences; the concern being that negative&#xD;
      mood states could precipitate disordered eating. Alternatively, other evidence suggests&#xD;
      positive psychological outcomes related to daily self-weighing in young adults.&#xD;
&#xD;
      Technological advances have allowed for users to track personal health information in real&#xD;
      time. Given that 60% of U.S. adults track weight, diet, or exercise, and 92% of adults aged&#xD;
      18-34 own a smartphone, electronic self-monitoring is feasible in this population. What is&#xD;
      less known is individuals' psychological and behavioral response to self-monitoring. This&#xD;
      original, important study will contribute to the fields of obesity and eating disorders and&#xD;
      experimentally test the psychological effects of this daily weight-control intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">December 29, 2017</completion_date>
  <primary_completion_date type="Actual">December 20, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>psychological response to daily self-weighing</measure>
    <time_frame>3 Months</time_frame>
    <description>Daily self-weighing will result in significantly greater reactivity than daily-temperature-taking&#xD;
There will be no significance in mood ratings between daily self-weighing and daily temperature-taking groups for EMA recordings later in the day.&#xD;
The daily self-weighing group will report significantly more weight control behaviors at the end of the day as compared to the daily temperature-taking group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identify moderators of response to daily self-weighing in a college-aged female population</measure>
    <time_frame>3 Months</time_frame>
    <description>Participants with lower baseline dietary restraint scores will experience significantly greater success in preventing weight gain over 3 months in response to daily self-weighing as compared to daily temperature-taking, in comparison to those with higher baseline dietary restraint scores&#xD;
Participants with higher baseline body satisfaction, lower body consciousness, and higher-self esteem will have significantly more favorable reactions to daily self-weighing, both in terms of momentary mood and prevention of weight gain over 3 months&#xD;
Baseline weight status will moderate the effectiveness of daily self-weighing as a weight gain prevention tool, such that it will work significantly better for overweight patients.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Daily Self-weighing</condition>
  <condition>Daily Temperature-taking</condition>
  <arm_group>
    <arm_group_label>Daily Self-Weighing Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be provided with a scale and instructions necessary to engage in daily self-weighing, first thing in the morning for the next three months.&#xD;
Height and weight will be measured using standard procedures&#xD;
Questionnaires will be administered at baseline and EOT: Sociodemographic questions (i.e. age, race/ethnicity, self-weighing frequency, weight goals will be collected at baseline. To assess factors that may modify reaction to intervention condition,a questionnaire will assess participant's eating attitudes, behaviors, and perception of their body.&#xD;
Questionnaires (baseline, end of Week 1, 2, 3, 4 and EOT): In order to compare results with published studies assessing constructs over varying time frames, self-esteem, anxiety, and depression will be measured at baseline, weekly for the first month, and again at EOT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Daily Temperature-Taking Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be provided with a thermometer and instructions necessary to engage in daily temperature-taking, first thing in the morning for the next three months.&#xD;
Height and weight will be measured using standard procedures&#xD;
Questionnaires will be administered at baseline and EOT: Sociodemographic questions (i.e. age, race/ethnicity, self-weighing frequency, weight goals will be collected at baseline. To assess factors that may modify reaction to intervention condition,a questionnaire will assess participant's eating attitudes, behaviors, and perception of their body.&#xD;
Questionnaires (baseline, end of Week 1, 2, 3, 4 and EOT): In order to compare results with published studies assessing constructs over varying time frames, self-esteem, anxiety, and depression will be measured at baseline, weekly for the first month, and again at EOT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>daily self-weighing</intervention_name>
    <description>Participants are provided with a wifi-enabled scale and asked to weigh themselves daily, first thing in the morning.</description>
    <arm_group_label>Daily Self-Weighing Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>daily temperature-taking</intervention_name>
    <description>Participants are provided with a wifi-enabled thermometer and asked to take their temperature daily, first thing in the morning.</description>
    <arm_group_label>Daily Temperature-Taking Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Between the ages of 18 and 26&#xD;
&#xD;
          -  UD student&#xD;
&#xD;
          -  Owns a smart phone&#xD;
&#xD;
          -  If participant does not currently have an eating disorder or has never had one in the&#xD;
             past&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If participant currently has an eating disorder or has had one in the past&#xD;
&#xD;
          -  If participant answers &quot;yes&quot; to 3 or more items in SCOFF&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Delaware</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>October 3, 2018</last_update_submitted>
  <last_update_submitted_qc>October 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Delaware</investigator_affiliation>
    <investigator_full_name>Carly R Pacanowski</investigator_full_name>
    <investigator_title>Assistant Professor (2C1001)</investigator_title>
  </responsible_party>
  <keyword>self-weighing</keyword>
  <keyword>weight gain</keyword>
  <keyword>Ecological Momentary Assessment</keyword>
  <keyword>mood</keyword>
  <keyword>emerging adulthood</keyword>
  <keyword>obesity</keyword>
  <keyword>eating disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03273491
org study id: 17A00813
nct id: NCT03273491
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to experimentally test the momentary and more distal
      psychological effects of daily self weighing as compared to an active control group.
Two significant public health problems, obesity and eating disorders, are prevalent during
      emerging adulthood, a unique stage of life between ages 18 and 25. Over half of emerging
      adults experience weight gain and/or disordered eating (e.g. overly restrictive dieting,
      binge eating); both of which contribute to obesity. Because many emerging adults attend
      college, the college community represents a viable population for implementing interventions
      to prevent weight gain, while not triggering disordered eating.

      A promising strategy for preventing weight gain during college is daily self-weighing, an
      example of behavioral self-monitoring, an evidence-based strategy for weight control.
      Self-monitoring is fundamental to behavior change: feedback allows the user to evaluate
      progress in relation to a goal and modify behavior. Despite self-monitoring being
      recommended, some evidence suggests that self-monitoring strategies, self-weighing in
      particular, may have unintended psychological consequences; the concern being that negative
      mood states could precipitate disordered eating. Alternatively, other evidence suggests
      positive psychological outcomes related to daily self-weighing in young adults.

      Technological advances have allowed for users to track personal health information in real
      time. Given that 60% of U.S. adults track weight, diet, or exercise, and 92% of adults aged
      18-34 own a smartphone, electronic self-monitoring is feasible in this population. What is
      less known is individuals' psychological and behavioral response to self-monitoring. This
      original, important study will contribute to the fields of obesity and eating disorders and
      experimentally test the psychological effects of this daily weight-control intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: psychological response to daily self-weighing
time frame: 3 Months
description: Daily self-weighing will result in significantly greater reactivity than daily-temperature-taking
There will be no significance in mood ratings between daily self-weighing and daily temperature-taking groups for EMA recordings later in the day.
The daily self-weighing group will report significantly more weight control behaviors at the end of the day as compared to the daily temperature-taking group.
measure: Identify moderators of response to daily self-weighing in a college-aged female population
time frame: 3 Months
description: Participants with lower baseline dietary restraint scores will experience significantly greater success in preventing weight gain over 3 months in response to daily self-weighing as compared to daily temperature-taking, in comparison to those with higher baseline dietary restraint scores
Participants with higher baseline body satisfaction, lower body consciousness, and higher-self esteem will have significantly more favorable reactions to daily self-weighing, both in terms of momentary mood and prevention of weight gain over 3 months
Baseline weight status will moderate the effectiveness of daily self-weighing as a weight gain prevention tool, such that it will work significantly better for overweight patients.
arm group label: Daily Self-Weighing Group
arm group type: Experimental
description: Participants will be provided with a scale and instructions necessary to engage in daily self-weighing, first thing in the morning for the next three months.
Height and weight will be measured using standard procedures
Questionnaires will be administered at baseline and EOT: Sociodemographic questions (i.e. age, race/ethnicity, self-weighing frequency, weight goals will be collected at baseline. To assess factors that may modify reaction to intervention condition,a questionnaire will assess participant's eating attitudes, behaviors, and perception of their body.
Questionnaires (baseline, end of Week 1, 2, 3, 4 and EOT): In order to compare results with published studies assessing constructs over varying time frames, self-esteem, anxiety, and depression will be measured at baseline, weekly for the first month, and again at EOT.
arm group label: Daily Temperature-Taking Group
arm group type: Active Comparator
description: Participants will be provided with a thermometer and instructions necessary to engage in daily temperature-taking, first thing in the morning for the next three months.
Height and weight will be measured using standard procedures
Questionnaires will be administered at baseline and EOT: Sociodemographic questions (i.e. age, race/ethnicity, self-weighing frequency, weight goals will be collected at baseline. To assess factors that may modify reaction to intervention condition,a questionnaire will assess participant's eating attitudes, behaviors, and perception of their body.
Questionnaires (baseline, end of Week 1, 2, 3, 4 and EOT): In order to compare results with published studies assessing constructs over varying time frames, self-esteem, anxiety, and depression will be measured at baseline, weekly for the first month, and again at EOT.
intervention type: Behavioral
intervention name: daily self-weighing
description: Participants are provided with a wifi-enabled scale and asked to weigh themselves daily, first thing in the morning.
arm group label: Daily Self-Weighing Group
intervention type: Behavioral
intervention name: daily temperature-taking
description: Participants are provided with a wifi-enabled thermometer and asked to take their temperature daily, first thing in the morning.
arm group label: Daily Temperature-Taking Group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Delaware
investigator full name: Carly R Pacanowski
investigator title: Assistant Professor (2C1001)
mesh term: Body Weight
sharing ipd: Yes