<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/NCT02990494</url>
  </required_header>
  <id_info>
    <org_study_id>1R03DK106405-01A1</org_study_id>
    <nct_id>NCT02990494</nct_id>
  </id_info>
  <brief_title>Prevention &amp; Promotion in the Treatment of Obesity</brief_title>
  <acronym>PROSPER</acronym>
  <official_title>Prevention &amp; Promotion in the Treatment of Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Miriam Hospital</source>
  <brief_summary>
    <textblock>
      Making healthy food choices requires sacrificing immediate pleasures of consuming high&#xD;
      calorie foods in order to achieve long-term health goals. Two strategies to encourage such&#xD;
      future thinking are 1) focusing on the long-term consequences of consuming unhealthy foods,&#xD;
      and 2) focusing on the long-term benefits of avoiding these unhealthy foods. Two novel&#xD;
      behavioral weight loss (BWL) interventions will be developed based on these strategies&#xD;
      (PREVENT and PROMOTE) and compared to standard Internet-delivered BWL to test their&#xD;
      feasibility and efficacy in changing food choice decision-making, reducing food cravings, and&#xD;
      ultimate weight loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is one of the most important public health issues today, contributing to many of the&#xD;
      primary causes of morbidity and mortality in the United States. Still, treatment remains&#xD;
      difficult and many people continually struggle to lose weight. Thus there is critical need&#xD;
      for improvements in methods for treating obesity. One potential reason weight control is so&#xD;
      difficult is the need to sacrifice immediate pleasures for long-term goals. This requires&#xD;
      placing significant value on future outcomes, such as health.&#xD;
&#xD;
      One strategy for doing so is to focus on the potential benefits of avoiding unhealthy&#xD;
      choices. Health messaging studies suggest that messages focused on promoting long-term&#xD;
      benefits of healthier choices may be effective in encouraging initiation of, or positive&#xD;
      attitudes toward, healthy behaviors, however, longer-term effects of these messages have not&#xD;
      been studied in the context of obesity. By contrast, behavioral economic work on Prospect&#xD;
      Theory suggests focusing on preventing future negative consequences may be superior, and the&#xD;
      threat of weight gain is a more powerful motivator than the benefit of weight loss. Although&#xD;
      prevention strategies have been successfully employed in smoking cessation and anti-smoking&#xD;
      campaigns, they are not typically used in obesity treatment. In promising preliminary&#xD;
      neuroimaging work, the investigators identified increases in brain regions involved in&#xD;
      inhibitory control and decreases in cravings when using this PREVENT strategy.&#xD;
&#xD;
      The goal of this R03 is to test whether an intervention built upon the goal to PREVENT&#xD;
      long-term consequences of weight gain versus an intervention built upon the goal to PROMOTE&#xD;
      long-term benefits of weight loss is beneficial in altering valuation of health and taste in&#xD;
      food choice decision-making, encouraging adherence, reducing food cravings and consumption,&#xD;
      and ultimate weight loss, as compared to a standard behavioral weight loss program (BWL). A&#xD;
      total of 90 overweight/obese men and women will be randomly assigned to either PREVENT,&#xD;
      PROMOTE, or standard BWL. Each intervention will have one in-person training session wherein&#xD;
      participants will learn key strategies of their assigned program, and the remaining 12 weekly&#xD;
      lessons will be delivered via internet. Baseline and 3-month (post-treatment) assessments&#xD;
      will include the food choice decision-making task featured in the parent K01 to measure&#xD;
      valuation of health and taste, weight measurement, and measurement of food cravings and&#xD;
      consumption. To address feasibility, adherence and engagement measures (i.e., lessons viewed,&#xD;
      self-monitoring) will be collected during the internet program, and memory for lesson content&#xD;
      will be assessed post-treatment. Individual difference measures will also be collected to&#xD;
      provide preliminary data on factors that may influence success in each arm.&#xD;
&#xD;
      This project tests innovative approaches in the clinical treatment of obesity and will&#xD;
      provide new insights into the potential role of prevention versus promotion strategies for&#xD;
      weight loss.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in food choice decision-making task</measure>
    <time_frame>baseline baseline and within 30 days of intervention conclusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>adherence and acceptability questionnaire</measure>
    <time_frame>during 12-week intervention and within 30 days of intervention conclusion</time_frame>
    <description>assessing adherence (number of lessons viewed and self-monitoring data entered by participants) throughout the intervention and acceptability of the intervention following treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in cravings and consumption questionnaire</measure>
    <time_frame>from baseline to within 30 days of intervention conclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in scale-measured body weight</measure>
    <time_frame>from baseline to within 30 days of intervention conclusion</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>STANDARD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12-week Internet-delivered behavioral weight loss program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PREVENT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>an enhanced 12-week Internet-delivered behavioral weight loss program focused on preventing future negative consequences</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PROMOTE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>an enhanced 12-week Internet-delivered behavioral weight loss program focused on promoting future benefits</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>STANDARD</intervention_name>
    <description>Standard Internet-delivered behavioral weight loss</description>
    <arm_group_label>STANDARD</arm_group_label>
    <other_name>Standard Internet-delivered behavioral weight loss</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PREVENT</intervention_name>
    <description>enhanced standard Internet-delivered behavioral weight loss program</description>
    <arm_group_label>PREVENT</arm_group_label>
    <other_name>PREVENT Internet-delivered behavioral weight loss</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PROMOTE</intervention_name>
    <description>enhanced standard Internet-delivered behavioral weight loss program</description>
    <arm_group_label>PROMOTE</arm_group_label>
    <other_name>PROMOTE Internet-delivered behavioral weight loss</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 25-60&#xD;
&#xD;
          -  currently overweight or obese (BMI 25-45 kg/m2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lack of access to a computer and the Internet (needed once per week),&#xD;
&#xD;
          -  weight loss medications&#xD;
&#xD;
          -  neurological or psychiatric conditions including but not limited to schizophrenia, and&#xD;
             bipolar disorder&#xD;
&#xD;
          -  inability to attend assessments&#xD;
&#xD;
          -  lack of interest in participating in a behavioral weight loss trial&#xD;
&#xD;
          -  serious current physical disease for which physician supervision of diet and exercise&#xD;
             prescription is needed&#xD;
&#xD;
          -  physical problems that limit the ability to exercise&#xD;
&#xD;
          -  participation in a weight loss program within the last 2 months&#xD;
&#xD;
          -  intention to become pregnant in the next 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>August 14, 2018</last_update_submitted>
  <last_update_submitted_qc>August 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Miriam Hospital</investigator_affiliation>
    <investigator_full_name>Kathryn E. Demos</investigator_full_name>
    <investigator_title>Assistant Professor (Research)</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT02990494
org study id: 1R03DK106405-01A1
nct id: NCT02990494
lead sponsor: 
Making healthy food choices requires sacrificing immediate pleasures of consuming high
      calorie foods in order to achieve long-term health goals. Two strategies to encourage such
      future thinking are 1) focusing on the long-term consequences of consuming unhealthy foods,
      and 2) focusing on the long-term benefits of avoiding these unhealthy foods. Two novel
      behavioral weight loss (BWL) interventions will be developed based on these strategies
      (PREVENT and PROMOTE) and compared to standard Internet-delivered BWL to test their
      feasibility and efficacy in changing food choice decision-making, reducing food cravings, and
      ultimate weight loss.
Obesity is one of the most important public health issues today, contributing to many of the
      primary causes of morbidity and mortality in the United States. Still, treatment remains
      difficult and many people continually struggle to lose weight. Thus there is critical need
      for improvements in methods for treating obesity. One potential reason weight control is so
      difficult is the need to sacrifice immediate pleasures for long-term goals. This requires
      placing significant value on future outcomes, such as health.

      One strategy for doing so is to focus on the potential benefits of avoiding unhealthy
      choices. Health messaging studies suggest that messages focused on promoting long-term
      benefits of healthier choices may be effective in encouraging initiation of, or positive
      attitudes toward, healthy behaviors, however, longer-term effects of these messages have not
      been studied in the context of obesity. By contrast, behavioral economic work on Prospect
      Theory suggests focusing on preventing future negative consequences may be superior, and the
      threat of weight gain is a more powerful motivator than the benefit of weight loss. Although
      prevention strategies have been successfully employed in smoking cessation and anti-smoking
      campaigns, they are not typically used in obesity treatment. In promising preliminary
      neuroimaging work, the investigators identified increases in brain regions involved in
      inhibitory control and decreases in cravings when using this PREVENT strategy.

      The goal of this R03 is to test whether an intervention built upon the goal to PREVENT
      long-term consequences of weight gain versus an intervention built upon the goal to PROMOTE
      long-term benefits of weight loss is beneficial in altering valuation of health and taste in
      food choice decision-making, encouraging adherence, reducing food cravings and consumption,
      and ultimate weight loss, as compared to a standard behavioral weight loss program (BWL). A
      total of 90 overweight/obese men and women will be randomly assigned to either PREVENT,
      PROMOTE, or standard BWL. Each intervention will have one in-person training session wherein
      participants will learn key strategies of their assigned program, and the remaining 12 weekly
      lessons will be delivered via internet. Baseline and 3-month (post-treatment) assessments
      will include the food choice decision-making task featured in the parent K01 to measure
      valuation of health and taste, weight measurement, and measurement of food cravings and
      consumption. To address feasibility, adherence and engagement measures (i.e., lessons viewed,
      self-monitoring) will be collected during the internet program, and memory for lesson content
      will be assessed post-treatment. Individual difference measures will also be collected to
      provide preliminary data on factors that may influence success in each arm.

      This project tests innovative approaches in the clinical treatment of obesity and will
      provide new insights into the potential role of prevention versus promotion strategies for
      weight loss.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in food choice decision-making task
time frame: baseline baseline and within 30 days of intervention conclusion
measure: adherence and acceptability questionnaire
time frame: during 12-week intervention and within 30 days of intervention conclusion
description: assessing adherence (number of lessons viewed and self-monitoring data entered by participants) throughout the intervention and acceptability of the intervention following treatment
measure: change in cravings and consumption questionnaire
time frame: from baseline to within 30 days of intervention conclusion
measure: change in scale-measured body weight
time frame: from baseline to within 30 days of intervention conclusion
arm group label: STANDARD
arm group type: Active Comparator
description: 12-week Internet-delivered behavioral weight loss program
arm group label: PREVENT
arm group type: Experimental
description: an enhanced 12-week Internet-delivered behavioral weight loss program focused on preventing future negative consequences
arm group label: PROMOTE
arm group type: Experimental
description: an enhanced 12-week Internet-delivered behavioral weight loss program focused on promoting future benefits
intervention type: Behavioral
intervention name: STANDARD
description: Standard Internet-delivered behavioral weight loss
arm group label: STANDARD
other name: Standard Internet-delivered behavioral weight loss
intervention type: Behavioral
intervention name: PREVENT
description: enhanced standard Internet-delivered behavioral weight loss program
arm group label: PREVENT
other name: PREVENT Internet-delivered behavioral weight loss
intervention type: Behavioral
intervention name: PROMOTE
description: enhanced standard Internet-delivered behavioral weight loss program
arm group label: PROMOTE
other name: PROMOTE Internet-delivered behavioral weight loss
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: The Miriam Hospital
investigator full name: Kathryn E. Demos
investigator title: Assistant Professor (Research)
mesh term: Obesity