<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/NCT01660685</url>
  </required_header>
  <id_info>
    <org_study_id>39952EP</org_study_id>
    <nct_id>NCT01660685</nct_id>
  </id_info>
  <brief_title>Effects of Journaling on Weight Loss</brief_title>
  <official_title>Effects of Journaling on Weight Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled trial with enhanced usual care treatment control. The aim is&#xD;
      to determine the effects of journaling and use of resource website on weight loss. There will&#xD;
      be two groups of 55 participants each. The intervention condition will be asked to record&#xD;
      daily weight, physical activity steps taken and pre-portioned food items and to complete two&#xD;
      daily journaling activities. Participants will also receive weekly tracing data, a weekly&#xD;
      blog from the principal investigator and have access to a weight control website. The control&#xD;
      group will not have access to the tracking, journaling or website for three months.&#xD;
      Investigators hypothesize that a website paired with tracking and journaling will be more&#xD;
      effective in helping participants lose weight.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will call study line given on recruitment materials and be screened over the&#xD;
      phone.&#xD;
&#xD;
      Baseline visit:&#xD;
&#xD;
      Individuals who meet the screening criteria will be invited to a one-hour training session&#xD;
      about the website and diet plan book. During the training, a coordinator will review the&#xD;
      consent form with the participants and ask if they have any questions. The coordinator will&#xD;
      take consented individuals' height, weight and blood pressure measurements. Participants will&#xD;
      be given a pedometer to use during physical activities and a meal replacement book to use as&#xD;
      a resource.&#xD;
&#xD;
      After baseline visit:&#xD;
&#xD;
      All participants will complete surveys online (Demographics, Three-Factor Eating&#xD;
      Questionnaire, Motivation, Weight Loss Habits, Medication log, International Physical&#xD;
      Activity Questionnaire) and be randomized into one of two groups. The intervention group will&#xD;
      be asked to record their weight, physical activity steps, pre-portioned food items and&#xD;
      journal entries on a daily basis. The control group will be sent an email informing them they&#xD;
      will have access to the tracking, journals and website in three months.&#xD;
&#xD;
      Intervention Group:&#xD;
&#xD;
      Participants will receive daily emails with links to record their weight, physical activity&#xD;
      steps and pre-portioned food items; participants will also complete a journaling response to&#xD;
      two writing prompts. The emails will contain links to the website to be used as a resource.&#xD;
      Every week, participants will enter whether they have an appointment with primary care&#xD;
      provider in the next week. Participants will also receive weekly blogs from the principal&#xD;
      investigator; participants can opt out of receiving the blog emails at any time. Coordinators&#xD;
      will review the database weekly. If a participant has lost ten pounds, they will be emailed&#xD;
      to call their doctor since weight loss can affect blood pressure and medication needs. If a&#xD;
      participant has an upcoming primary care provider appointment, they will be emailed to print&#xD;
      out their tracking graphs (weight, steps taken, meal replacements). Coordinators will also&#xD;
      monitor journal responses; coordinators will contact participants who wrote useful entries to&#xD;
      ask if the participant's responses can be shared with other participants. Shared posts will&#xD;
      be anonymous; only the age of the individual will be given.&#xD;
&#xD;
      Month one and two visits:&#xD;
&#xD;
      Participants from both groups will be asked to come to Hershey Medical Center to have their&#xD;
      height, weight and blood pressure measured.&#xD;
&#xD;
      Month three visit:&#xD;
&#xD;
      Participants from both groups will be asked to come to Hershey Medical Center to have their&#xD;
      height, weight and blood pressure measured. Prior to their visit, participants will be asked&#xD;
      to complete a series of surveys online (Three-Factor Eating Questionnaire, Motivation, Weight&#xD;
      Loss Habits, Medication log, International Physical Activity Questionnaire, Satisfaction).&#xD;
      Participants in the control group will be given a booklet containing the writing prompts,&#xD;
      tracking and website address to complete on their own if they so choose.&#xD;
&#xD;
      Participants will be asked if they would like to come back for an optional video interview.&#xD;
      The interview will consist of six questions about their experience with the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>3 months</time_frame>
    <description>Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>3 months</time_frame>
    <description>Blood pressure will be measured by study staff using an automatic blood pressure monitor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>3 months</time_frame>
    <description>Height will be measured using a portable stadiometer.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sociodemographics and tobacco use</measure>
    <time_frame>3 months</time_frame>
    <description>Age, gender, race, ethnicity, education, smoking status and other demographics will be measured by self-report</description>
  </other_outcome>
  <other_outcome>
    <measure>Three-factor Eating Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire asks participants about how their dietary restraint in specific circumstances</description>
  </other_outcome>
  <other_outcome>
    <measure>Motivation</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire asks participants to gauge their motivation to lose weight.</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight Loss Habits</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire asks participants how often they use specific habits to lose weight</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Pressure Medication</measure>
    <time_frame>3 months</time_frame>
    <description>Blood pressure medication names, doses and frequency measured by self-report</description>
  </other_outcome>
  <other_outcome>
    <measure>International Physical Activity Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire asks participants to estimate the frequency and duration of specific physical activities</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction Survey</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire asks participants about their satisfaction with specific aspects of the study</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Overweight</condition>
  <condition>Obese</condition>
  <arm_group>
    <arm_group_label>Tracking + Journaling + Website</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tracking</intervention_name>
    <description>Participants will record their daily weight, physical activity steps and meal replacements online</description>
    <arm_group_label>Tracking + Journaling + Website</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Journaling</intervention_name>
    <description>Participants will journal to two online writing prompts: one on positive focus and one on goal setting</description>
    <arm_group_label>Tracking + Journaling + Website</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Website</intervention_name>
    <description>Participants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants.</description>
    <arm_group_label>Tracking + Journaling + Website</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Usual Care</intervention_name>
    <description>Participants will receive standard care of monthly height, weight and blood pressure measurements. Participants will also receive a pedometer and a diet plan book on pre-portioned items.</description>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
    <arm_group_label>Tracking + Journaling + Website</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  21 to 65 years old&#xD;
&#xD;
          -  Body mass index between 27 and 45&#xD;
&#xD;
          -  E-mail and Internet access&#xD;
&#xD;
          -  Able to read, write, and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight loss of more than 5% of current body weight in previous 6 months&#xD;
&#xD;
          -  Participated in weight loss research in previous 6 months&#xD;
&#xD;
          -  Current use of weight loss medication or program&#xD;
&#xD;
          -  History of or scheduled weight loss surgery&#xD;
&#xD;
          -  Heart, liver, or kidney failure&#xD;
&#xD;
          -  Been told by doctor of heart trouble&#xD;
&#xD;
          -  Frequent pains in heart and chest&#xD;
&#xD;
          -  Often feel faint or have spells of severe dizziness&#xD;
&#xD;
          -  Bone or joint problem that has been or might be aggravated by exercise&#xD;
&#xD;
          -  Physical reason for not following activity program&#xD;
&#xD;
          -  History of sever cognitive impairment or major psychiatric illness&#xD;
&#xD;
          -  Pregnant in previous 6 months, currently or planning to become pregnant in next 3&#xD;
             months&#xD;
&#xD;
          -  Moving in next 6 months&#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>Christopher Sciamanna, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Milton S. Hershey Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>January 31, 2013</last_update_submitted>
  <last_update_submitted_qc>January 31, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Christopher Sciamanna, MD, MPH</investigator_full_name>
    <investigator_title>Chief, Division of General Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>Weight loss</keyword>
  <keyword>Web-based</keyword>
  <keyword>Journaling</keyword>
  <keyword>Body Mass Index between 27 and 45</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT01660685
org study id: 39952EP
nct id: NCT01660685
lead sponsor: 
has dmc: No
This is a randomized controlled trial with enhanced usual care treatment control. The aim is
      to determine the effects of journaling and use of resource website on weight loss. There will
      be two groups of 55 participants each. The intervention condition will be asked to record
      daily weight, physical activity steps taken and pre-portioned food items and to complete two
      daily journaling activities. Participants will also receive weekly tracing data, a weekly
      blog from the principal investigator and have access to a weight control website. The control
      group will not have access to the tracking, journaling or website for three months.
      Investigators hypothesize that a website paired with tracking and journaling will be more
      effective in helping participants lose weight.
Participants will call study line given on recruitment materials and be screened over the
      phone.

      Baseline visit:

      Individuals who meet the screening criteria will be invited to a one-hour training session
      about the website and diet plan book. During the training, a coordinator will review the
      consent form with the participants and ask if they have any questions. The coordinator will
      take consented individuals' height, weight and blood pressure measurements. Participants will
      be given a pedometer to use during physical activities and a meal replacement book to use as
      a resource.

      After baseline visit:

      All participants will complete surveys online (Demographics, Three-Factor Eating
      Questionnaire, Motivation, Weight Loss Habits, Medication log, International Physical
      Activity Questionnaire) and be randomized into one of two groups. The intervention group will
      be asked to record their weight, physical activity steps, pre-portioned food items and
      journal entries on a daily basis. The control group will be sent an email informing them they
      will have access to the tracking, journals and website in three months.

      Intervention Group:

      Participants will receive daily emails with links to record their weight, physical activity
      steps and pre-portioned food items; participants will also complete a journaling response to
      two writing prompts. The emails will contain links to the website to be used as a resource.
      Every week, participants will enter whether they have an appointment with primary care
      provider in the next week. Participants will also receive weekly blogs from the principal
      investigator; participants can opt out of receiving the blog emails at any time. Coordinators
      will review the database weekly. If a participant has lost ten pounds, they will be emailed
      to call their doctor since weight loss can affect blood pressure and medication needs. If a
      participant has an upcoming primary care provider appointment, they will be emailed to print
      out their tracking graphs (weight, steps taken, meal replacements). Coordinators will also
      monitor journal responses; coordinators will contact participants who wrote useful entries to
      ask if the participant's responses can be shared with other participants. Shared posts will
      be anonymous; only the age of the individual will be given.

      Month one and two visits:

      Participants from both groups will be asked to come to Hershey Medical Center to have their
      height, weight and blood pressure measured.

      Month three visit:

      Participants from both groups will be asked to come to Hershey Medical Center to have their
      height, weight and blood pressure measured. Prior to their visit, participants will be asked
      to complete a series of surveys online (Three-Factor Eating Questionnaire, Motivation, Weight
      Loss Habits, Medication log, International Physical Activity Questionnaire, Satisfaction).
      Participants in the control group will be given a booklet containing the writing prompts,
      tracking and website address to complete on their own if they so choose.

      Participants will be asked if they would like to come back for an optional video interview.
      The interview will consist of six questions about their experience with the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight
time frame: 3 months
description: Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.
measure: Blood Pressure
time frame: 3 months
description: Blood pressure will be measured by study staff using an automatic blood pressure monitor.
measure: Height
time frame: 3 months
description: Height will be measured using a portable stadiometer.
measure: Sociodemographics and tobacco use
time frame: 3 months
description: Age, gender, race, ethnicity, education, smoking status and other demographics will be measured by self-report
measure: Three-factor Eating Questionnaire
time frame: 3 months
description: Questionnaire asks participants about how their dietary restraint in specific circumstances
measure: Motivation
time frame: 3 months
description: Questionnaire asks participants to gauge their motivation to lose weight.
measure: Weight Loss Habits
time frame: 3 months
description: Questionnaire asks participants how often they use specific habits to lose weight
measure: Blood Pressure Medication
time frame: 3 months
description: Blood pressure medication names, doses and frequency measured by self-report
measure: International Physical Activity Questionnaire
time frame: 3 months
description: Questionnaire asks participants to estimate the frequency and duration of specific physical activities
measure: Satisfaction Survey
time frame: 3 months
description: Questionnaire asks participants about their satisfaction with specific aspects of the study
arm group label: Tracking + Journaling + Website
arm group type: Experimental
description: In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.
arm group label: Enhanced Usual Care
arm group type: Active Comparator
description: Participants receive standard care
intervention type: Behavioral
intervention name: Tracking
description: Participants will record their daily weight, physical activity steps and meal replacements online
arm group label: Tracking + Journaling + Website
intervention type: Behavioral
intervention name: Journaling
description: Participants will journal to two online writing prompts: one on positive focus and one on goal setting
arm group label: Tracking + Journaling + Website
intervention type: Behavioral
intervention name: Website
description: Participants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants.
arm group label: Tracking + Journaling + Website
intervention type: Behavioral
intervention name: Enhanced Usual Care
description: Participants will receive standard care of monthly height, weight and blood pressure measurements. Participants will also receive a pedometer and a diet plan book on pre-portioned items.
arm group label: Enhanced Usual Care
arm group label: Tracking + Journaling + Website
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Christopher Sciamanna, MD, MPH
role: Principal Investigator
affiliation: Milton S. Hershey Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Christopher Sciamanna, MD, MPH
investigator title: Chief, Division of General Internal Medicine
mesh term: Overweight
mesh term: Weight Loss