<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/NCT03003403</url>
  </required_header>
  <id_info>
    <org_study_id>D0479</org_study_id>
    <nct_id>NCT03003403</nct_id>
  </id_info>
  <brief_title>Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care</brief_title>
  <official_title>Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Up to 50% of obese patients are not interested in, or ready for, weight loss. Clinical&#xD;
      practice guidelines clearly recommend that these patients avoid gaining weight. However,&#xD;
      despite this clinical guideline, weight gain prevention interventions are not available in&#xD;
      primary care practice. Balance is a pragmatic, randomized controlled effectiveness trial for&#xD;
      weight gain prevention for patients within rural community health centers, using a digital&#xD;
      health platform.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical practice guidelines emphasize recommend weight gain prevention, but evidence-based&#xD;
      treatments are not available in primary care. Balance, a pragmatic effectiveness trial, will&#xD;
      test a scalable treatment approach for medically-vulnerable adults, those who suffer&#xD;
      disproportionately from obesity and its adverse health effects. Balance builds on the design&#xD;
      and findings of the Shape study (NCT00938535) to test a pragmatic intervention within rural&#xD;
      community health centers. Balance will randomize overweight adults and adults with obesity&#xD;
      who are patients a local community health center network (Piedmont Health Services) to&#xD;
      either: 1) a 12-month weight gain prevention intervention or 2) usual care. Intervention&#xD;
      group components include tailored behavior change goals; mHealth self-monitoring and&#xD;
      feedback; skills training videos; and stepped responsive coaching from clinic Registered&#xD;
      Dietitians. The usual care group will receive standard primary care offered by their&#xD;
      providers and automated text messages and health information about maintaining a healthy&#xD;
      weight. All intervention components and materials will be provided in Spanish or English.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">April 30, 2023</completion_date>
  <primary_completion_date type="Actual">April 30, 2022</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>Change in weight</measure>
    <time_frame>baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)</time_frame>
    <description>The proportion of intervention arm participants who achieve weight maintenance (staying within 3% of baseline weight in kg) at 24 months post-randomization. This will be calculated as follows: ((baseline weight in kg - final weight at 24 months in kg)/baseline weight in kg))x 100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)</time_frame>
    <description>Average change in participant weight at 24 months post randomization, as measured in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)</time_frame>
    <description>Average change in participant systolic and diastolic blood pressure at 24 months post-randomization, as measured in millimeters of mercury (mm Hg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Framingham risk score</measure>
    <time_frame>baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)</time_frame>
    <description>Average change in participant Framingham risk score at 24 months post-randomization, as measured by calculated 10-year Framingham risk score from the Framingham Heart Study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention cost-effectiveness</measure>
    <time_frame>24 months post-randomization (up to 27 months to obtain 24 month data)</time_frame>
    <description>Assess the intervention's incremental cost at 24 months post-randomization, defined as the cost-effectiveness ratio of cost in dollars per kg of weight maintained at 24 mos, as compared to baseline weight in kg.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">443</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <condition>Overnutrition</condition>
  <condition>Nutrition Disorders</condition>
  <condition>Signs and Symptoms</condition>
  <arm_group>
    <arm_group_label>Intervention Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dieticians serving as health coaches within a local network of community health centers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Program</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention Program</intervention_name>
    <description>Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.</description>
    <arm_group_label>Intervention Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of Piedmont Health Services' community health centers in central North&#xD;
             Carolina only&#xD;
&#xD;
          -  BMI between 25 and 40 kg/m2 and weighs less than 380 lbs&#xD;
&#xD;
          -  Speaks English or Spanish&#xD;
&#xD;
          -  Had a non-urgent outpatient visit at a participating community health center clinic at&#xD;
             Piedmont Health Services within the last 2 weeks&#xD;
&#xD;
          -  Has a cell phone&#xD;
&#xD;
          -  Willing to receive 3-12 study-related text messages per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current Piedmont Health Services employee&#xD;
&#xD;
          -  Has past bariatric surgery or planned bariatric surgery (within next 2 years)&#xD;
&#xD;
          -  Diagnosed with cancer in the last 6 months and is in active treatment&#xD;
&#xD;
          -  Has a history of cardiovascular event (stroke/MI) in the last 12 months&#xD;
&#xD;
          -  Was hospitalized for a mental health issue in the last 12 months&#xD;
&#xD;
          -  Diagnosis of end stage renal disease&#xD;
&#xD;
          -  Currently participating in a weight loss program/research study&#xD;
&#xD;
          -  Plans to move out of area and not receive care within community health center network&#xD;
             (within the next 2 years)&#xD;
&#xD;
          -  Currently or recently pregnant (within the last 6 months) - Females only&#xD;
&#xD;
          -  Currently or recently lactating (with the last 2 months)- Females only&#xD;
&#xD;
          -  Plans to get pregnant in the next 12 months - Females only&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gary G Bennett, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dori M Steinberg, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University - with Piedmont Health Services, Inc.</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mHealth</keyword>
  <keyword>Digital Health</keyword>
  <keyword>Primary Care</keyword>
  <keyword>Pragmatic Clinical Trial</keyword>
  <keyword>Behavior Change</keyword>
  <keyword>Weight Management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Nutrition Disorders</mesh_term>
    <mesh_term>Overnutrition</mesh_term>
    <mesh_term>Weight Gain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03003403
org study id: D0479
nct id: NCT03003403
lead sponsor: 
has dmc: Yes
Up to 50% of obese patients are not interested in, or ready for, weight loss. Clinical
      practice guidelines clearly recommend that these patients avoid gaining weight. However,
      despite this clinical guideline, weight gain prevention interventions are not available in
      primary care practice. Balance is a pragmatic, randomized controlled effectiveness trial for
      weight gain prevention for patients within rural community health centers, using a digital
      health platform.
Clinical practice guidelines emphasize recommend weight gain prevention, but evidence-based
      treatments are not available in primary care. Balance, a pragmatic effectiveness trial, will
      test a scalable treatment approach for medically-vulnerable adults, those who suffer
      disproportionately from obesity and its adverse health effects. Balance builds on the design
      and findings of the Shape study (NCT00938535) to test a pragmatic intervention within rural
      community health centers. Balance will randomize overweight adults and adults with obesity
      who are patients a local community health center network (Piedmont Health Services) to
      either: 1) a 12-month weight gain prevention intervention or 2) usual care. Intervention
      group components include tailored behavior change goals; mHealth self-monitoring and
      feedback; skills training videos; and stepped responsive coaching from clinic Registered
      Dietitians. The usual care group will receive standard primary care offered by their
      providers and automated text messages and health information about maintaining a healthy
      weight. All intervention components and materials will be provided in Spanish or English.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in weight
time frame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
description: The proportion of intervention arm participants who achieve weight maintenance (staying within 3% of baseline weight in kg) at 24 months post-randomization. This will be calculated as follows: ((baseline weight in kg - final weight at 24 months in kg)/baseline weight in kg))x 100
measure: Change in weight
time frame: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
description: Average change in participant weight at 24 months post randomization, as measured in kg
measure: Change in blood pressure
time frame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
description: Average change in participant systolic and diastolic blood pressure at 24 months post-randomization, as measured in millimeters of mercury (mm Hg)
measure: Change in Framingham risk score
time frame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
description: Average change in participant Framingham risk score at 24 months post-randomization, as measured by calculated 10-year Framingham risk score from the Framingham Heart Study
measure: Intervention cost-effectiveness
time frame: 24 months post-randomization (up to 27 months to obtain 24 month data)
description: Assess the intervention's incremental cost at 24 months post-randomization, defined as the cost-effectiveness ratio of cost in dollars per kg of weight maintained at 24 mos, as compared to baseline weight in kg.
arm group label: Intervention Program
arm group type: Experimental
description: Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dieticians serving as health coaches within a local network of community health centers.
arm group label: Usual Care Program
arm group type: No Intervention
description: Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.
intervention type: Behavioral
intervention name: Intervention Program
description: Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.
arm group label: Intervention Program
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gary G Bennett, PhD
role: Principal Investigator
affiliation: Duke University
last name: Dori M Steinberg, PhD, RD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
mesh term: Nutrition Disorders
mesh term: Overnutrition
mesh term: Weight Gain
sharing ipd: No