<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/NCT03824769</url>
  </required_header>
  <id_info>
    <org_study_id>H18-153</org_study_id>
    <secondary_id>R21NR018359</secondary_id>
    <nct_id>NCT03824769</nct_id>
  </id_info>
  <brief_title>Physical Activity Choices Everyday</brief_title>
  <acronym>PACE</acronym>
  <official_title>Is Long-term Maintenance Worth the Wait? Using Real Time Data Capture to Examine Delayed Discounting as a Putative Target of Physical Activity Adherence in Weight Loss Maintenance Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Connecticut</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University at Buffalo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kent State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Connecticut</source>
  <oversight_info>
    <has_dmc>Yes</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 aims to test two strategies for weight loss maintenance. It involves two phases, a&#xD;
      weight loss phase and a maintenance phase. During Phase I (the weight loss phase),&#xD;
      participants will receive a 16-week, Web-based behavioral weight loss program that involves&#xD;
      access to weekly weight loss information and weekly personalized feedback on diet, activity,&#xD;
      and weight loss goals. Individuals who lose at least 5% of their initial body weight during&#xD;
      this program, will be invited to participate in Phase II. During Phase II, two 4-month&#xD;
      treatments for weight loss maintenance will be tested. At the beginning of Phase II,&#xD;
      participants will be randomly assigned to one of the two maintenance programs: (1) a&#xD;
      behavioral maintenance program that involves in-person group meetings plus daily exercises in&#xD;
      which information about a healthy lifestyle is reviewed or (2) a behavioral maintenance&#xD;
      program that involves in-person group meetings plus daily exercises in which descriptions of&#xD;
      positive future events are reviewed. Throughout the study, participants will complete&#xD;
      assessments that examine the effects of the interventions on delay discounting, physical&#xD;
      activity, weight, and other important health and psychosocial outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">May 3, 2021</completion_date>
  <primary_completion_date type="Actual">May 3, 2021</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>Physical Activity</measure>
    <time_frame>Phase II baseline to 1 month, 2 months and 4 months (end of treatment)</time_frame>
    <description>Change in minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during the Phase II maintenance program.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Delay Discounting</measure>
    <time_frame>Phase II baseline to 1 month, 2 months and 4 months (end of treatment)</time_frame>
    <description>Change in delay discounting measured using a choice task during the Phase II maintenance program</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>4 months</time_frame>
    <description>Weight change from end of Phase 1 weight loss program to end of Phase II maintenance program</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Behavioral Weight Loss Maintenance + Healthy Thinking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Behavioral Weight Loss Maintenance Treatment + Future Thinking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight Loss Maintenance + Healthy Thinking</intervention_name>
    <description>Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.</description>
    <arm_group_label>Behavioral Weight Loss Maintenance + Healthy Thinking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight Loss Maintenance Treatment + Future Thinking</intervention_name>
    <description>Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.</description>
    <arm_group_label>Behavioral Weight Loss Maintenance Treatment + Future Thinking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-70&#xD;
&#xD;
          -  Body Mass Index between 30-50&#xD;
&#xD;
          -  English Speaking&#xD;
&#xD;
          -  Have a smartphone that can be used for study activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Report being unable to walk 2 blocks without stopping&#xD;
&#xD;
          -  Are currently participating in weight loss treatment, have a history of bariatric&#xD;
             surgery, or lost ≥5% in the past 6-months&#xD;
&#xD;
          -  Are pregnant or plan to become pregnant within 1 year&#xD;
&#xD;
          -  Report a heart condition, chest pain during periods of rest or activity, or loss of&#xD;
             consciousness on the Physical Activity Readiness Questionnaire&#xD;
&#xD;
          -  Report a medical condition that could jeopardize their safety in a weight control&#xD;
             program with diet and exercise guidelines&#xD;
&#xD;
          -  History of or current traumatic brain injury, dementia or Alzheimer's disease; a&#xD;
             history of Multiple Sclerosis, or other neurological disorders&#xD;
&#xD;
          -  Report conditions that, in the judgment of the PI, would render them unlikely to&#xD;
             follow the protocol (e.g., relocation, dementia, unable to read and write in English)&#xD;
&#xD;
          -  Have no Internet access or unwilling to use personal smartphone for study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Gorin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Connecticut</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UConn Weight Management Research Laboratory</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Connecticut</investigator_affiliation>
    <investigator_full_name>Amy Gorin</investigator_full_name>
    <investigator_title>Director, Institute for Collaboration on Health, Intervention, and Policy Professor, Psychological Sciences</investigator_title>
  </responsible_party>
  <keyword>Weight Loss Maintenance</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 12, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03824769
org study id: H18-153
secondary id: R21NR018359
nct id: NCT03824769
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to test two strategies for weight loss maintenance. It involves two phases, a
      weight loss phase and a maintenance phase. During Phase I (the weight loss phase),
      participants will receive a 16-week, Web-based behavioral weight loss program that involves
      access to weekly weight loss information and weekly personalized feedback on diet, activity,
      and weight loss goals. Individuals who lose at least 5% of their initial body weight during
      this program, will be invited to participate in Phase II. During Phase II, two 4-month
      treatments for weight loss maintenance will be tested. At the beginning of Phase II,
      participants will be randomly assigned to one of the two maintenance programs: (1) a
      behavioral maintenance program that involves in-person group meetings plus daily exercises in
      which information about a healthy lifestyle is reviewed or (2) a behavioral maintenance
      program that involves in-person group meetings plus daily exercises in which descriptions of
      positive future events are reviewed. Throughout the study, participants will complete
      assessments that examine the effects of the interventions on delay discounting, physical
      activity, weight, and other important health and psychosocial outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Physical Activity
time frame: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
description: Change in minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during the Phase II maintenance program.
measure: Delay Discounting
time frame: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
description: Change in delay discounting measured using a choice task during the Phase II maintenance program
measure: Weight
time frame: 4 months
description: Weight change from end of Phase 1 weight loss program to end of Phase II maintenance program
arm group label: Behavioral Weight Loss Maintenance + Healthy Thinking
arm group type: Active Comparator
description: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.
arm group label: Behavioral Weight Loss Maintenance Treatment + Future Thinking
arm group type: Experimental
description: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.
intervention type: Behavioral
intervention name: Weight Loss Maintenance + Healthy Thinking
description: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.
arm group label: Behavioral Weight Loss Maintenance + Healthy Thinking
intervention type: Behavioral
intervention name: Weight Loss Maintenance Treatment + Future Thinking
description: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.
arm group label: Behavioral Weight Loss Maintenance Treatment + Future Thinking
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Amy Gorin, PhD
role: Principal Investigator
affiliation: University of Connecticut
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Connecticut
investigator full name: Amy Gorin
investigator title: Director, Institute for Collaboration on Health, Intervention, and Policy Professor, Psychological Sciences
sharing ipd: No
submitted: September 12, 2023