<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/NCT03832296</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00033618.I-CAN</org_study_id>
    <nct_id>NCT03832296</nct_id>
  </id_info>
  <brief_title>Independent Weight Loss Maintenance for Communities With Arthritis in North Carolina: the I-CAN Clinical Trial</brief_title>
  <acronym>I-CAN</acronym>
  <official_title>Independent Weight Loss Maintenance for Communities With Arthritis in North Carolina: the I-CAN Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</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 study team is currently conducting a pragmatic, community-based assessor-blinded&#xD;
      randomized controlled trial (RCT) in overweight and obese adults &gt; 50 years with knee OA in&#xD;
      both urban and rural counties in North Carolina. As the participants randomized to the 18&#xD;
      month diet and exercise group in the WE-CAN study successfully complete the intervention (≥&#xD;
      5% weight loss), the study team has the unique opportunity to evaluate the effectiveness of a&#xD;
      theoretically-based tapered weight maintenance intervention. Eligible participants will be&#xD;
      randomized to either the weight-loss maintenance or health education attention control&#xD;
      groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Results from the Intensive Diet and Exercise for Arthritis (IDEA) trial showed that 10%&#xD;
      diet-induced weight loss combined with exercise (D+E) was twice as effective at relieving&#xD;
      knee pain and improving function and mobility as previous long-term weight loss and exercise&#xD;
      programs in similar cohorts. The treatment effects of D+E on these clinical outcomes were&#xD;
      mediated by changes in self-efficacy over the course of the trial. However, most people tend&#xD;
      to regain most or all of the lost weight in three to five years. The challenge is maintaining&#xD;
      the weight loss and sustaining the efficacy of the intervention.&#xD;
&#xD;
      Our current trial (WE-CAN) is designed to adapt the successful IDEA intervention to&#xD;
      real-world clinical and community settings. As WE-CAN participants in the D+E group complete&#xD;
      their intervention, the investigators will leverage our organizational infrastructure to&#xD;
      maintain weight-loss without supervised intervention by increasing participant confidence to&#xD;
      establish and adhere to a routine of good exercise and diet behaviors independently.&#xD;
&#xD;
      Participants will include 212 older adults aged ≥ 51 yrs. with knee osteoarthritis (OA) who&#xD;
      achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial. All WE-CAN&#xD;
      participants meet the ACR clinical criteria for knee OA, which includes knee pain on most&#xD;
      days of the week plus at least three of the following six: age ≥ 50 years, stiffness &lt; 30&#xD;
      min/day, crepitus, bony tenderness, bony enlargement, and/or no palpable warmth. Eligible&#xD;
      WE-CAN D+E participants will be randomized to either 6-month facilitated weight-loss&#xD;
      maintenance or health education control interventions. The primary aim is to compare the&#xD;
      effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory&#xD;
      to a health education intervention on maintaining weight loss subsequent to a 12-month&#xD;
      unsupervised follow-up period. Secondary aims will compare the two interventions on WOMAC&#xD;
      knee pain and function, health-related quality of life (SF-36), 6-minute walk distance, and&#xD;
      weight-loss maintenance self-efficacy following the 12-month unsupervised period. The study&#xD;
      team will also establish the cost-effectiveness of a 6-month facilitated weight-loss&#xD;
      maintenance intervention for older adults with knee OA by conducting cost-effectiveness and&#xD;
      budgetary impact analyses using data from the current trial in a validated computer-simulated&#xD;
      model of knee OA.&#xD;
&#xD;
      There have been numerous attempts to prevent weight regain in adults. This study is&#xD;
      significant in that it is designed to encourage older adults with knee OA that have&#xD;
      experienced significant weight loss to develop strategies that will build self-efficacy for&#xD;
      maintaining weight loss on their own long after the active intervention ends.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 29, 2018</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>
    <intervention_model_description>Participants will include 212 older adults aged ≥ 51 yrs. with knee OA who achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial. Eligible WE-CAN D+E participants will be randomized to either the weight-loss maintenance or health education attention control groups.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Each eligible participant will be randomized to one of the two arms of the clinical trial (weight-loss maintenance, control) according to a variable block-length algorithm that will be controlled by the Data Management Group. Randomization will be stratified by intervention site to ensure nearly equal sample sizes for the two interventions to balance local population characteristics. Randomization uses a web-based system that is part of the study data management system. Intervention visits will not include any assessments and outcome assessors will remain blinded to group assignment. The lead biostatistician of the Data Management Group will develop the randomization table.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Weight-Loss Maintenance</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on maintaining weight loss subsequent to a 12-month unsupervised follow-up period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee Pain measured by the WOMAC Index</measure>
    <time_frame>18 Months</time_frame>
    <description>The investigators will measure self-reported pain using the WOMAC (scores will be pulled from the KOOS Questionnaire in which the WOMAC is embedded). The pain index assesses participants' pain on a scale, ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function measured by the WOMAC Index</measure>
    <time_frame>18 Months</time_frame>
    <description>The investigators will measure self-reported physical function using the WOMAC (scores will be pulled from the KOOS Questionnaire in which the WOMAC is embedded). The LK version asks participants to indicate on a scale from 0 (none) to 4 (extreme) the degree of difficulty experienced in the last week due to knee OA. Individual scores for the 17 items are totaled to generate a summary score that could range from 0-68, with higher scores indicating poorer function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life: SF-36</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on health-related quality of life (SF-36) subsequent to a 12-month unsupervised follow-up period. Two summary scores are acquired: physical health and mental health. Range=0-100. Higher scores indicate better health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility- 6 minute walk test</measure>
    <time_frame>18 Months</time_frame>
    <description>The primary mobility measure will be 6-minute walk distance. Participants are told to walk as far as possible in 6 minutes on an established course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy - Perceived Stress: questionnaire</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The perceived stress questionnaire will measure the degree to which people perceive their lives as stressful. Range = 0-40. Higher numbers indicate higher stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy - Walking Efficacy for Duration: walking efficacy for duration scale</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The walking efficacy for duration scale measures one's ability to walk/jog at a moderately fast pace for various durations. Range 0-100. A higher score indicates a higher self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy - PANAS</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Positive and Negative Affect (PANAS) measures both positive and negative affect, leading to more insightful outlooks regarding participants' feeling states. This scale consists of 20 items that reflect the intensity of how the participant &quot;feels&quot; right now. Range=10-50 for each subscale. A higher score for positive affect indicates a higher level of positive affect. A higher score for negative affect indicates a higher level of negative affect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy - Gait Efficacy - gait efficacy/environmental efficacy scale</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The gait efficacy/environmental efficacy scale will ask the participants' confidence in performing certain activities. Confidence in performing activities. Participants will be asked to indicate their level of confidence being able to complete different tasks. Range=0-100. A higher score indicates higher self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy - Satisfaction with Life: Satisfaction with life scale</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Satisfaction with life scale is focused to assess global life satisfaction. Range=5 to 35. A higher scale indicates a higher level of life satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy - Weight Efficacy Scale</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Weight Efficacy Lifestyle Questionnaire (WEL) is a 20-item measure employed to assess self-efficacy for weight management. Range=0 to 180. Higher numbers indicate better confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy - Adherence Self Efficacy Scale</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The adherence questionnaire is designed to assess beliefs in one's ability (confidence) to continue exercising at various intensities and frequencies. Range=0-100. A higher score indicates higher self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy - Barriers Self-Efficacy to Exercise</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Barriers Self-Efficacy to Exercise measures confidence in dealing with barriers to exercise. Range=0-100. Higher numbers indicate higher confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy - Multidimensional Outcome Expectations for Exercise Scale (MOEES): questionnaire</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The MOEES questionnaire consists of three subscales: physical outcome expectations (score range 6-30), social outcome expectations (score range 4-20), and self-evaluative outcome expectations (score range 5-25). Each subscale is scored by summing the numerical ratings for each response. Higher scores are indicative of higher levels of outcome expectations for exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy - Perceived Barriers: questionnaire</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The perceived barriers questionnaire measures a person's perceptions to barriers to performing exercise. The questionnaire is scored by finding the mean for each response (range = 1-5). Higher scores indicate higher perception of barriers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy - Weight Loss Maintenance: questionnaire</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy for maintaining weight loss. Range=0-100. Higher scores indicate more confidence in maintaining weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-Effectiveness</measure>
    <time_frame>18 Months</time_frame>
    <description>Resource utilization will be collected by questionnaire. MD and non-MD office visits will be collected via self-report with domains including visits to clinicians (physicians, nurses, physical therapists, others), tests, medications, injections, surgery, alternative therapies. The number of visits associated with utilization of each of 4 domains, MD visits, non-MD visits, ED visits, and inpatient stays, will be examined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-Effectiveness- WPAI</measure>
    <time_frame>18 Months</time_frame>
    <description>The Work Productivity and Activity Impairment index (WPAI) will be used to assess absenteeism and reduced productivity while at work (presenteeism). Outcome (OC) scores can be derived from the WPAI: OC1, percent work time missed due to health, (percentage of absenteeism); percent impairment while working due to health, (percentage of presenteeism); percent overall work impairment due to health, percent activity impairment due to health. For all 4 outcomes, greater scores (range 0-100%) indicate greater impact of health.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mobility - SPPB &amp; GaitRite</measure>
    <time_frame>18 Months</time_frame>
    <description>The Short Physical Performance Battery (SPPB) will be used to measure mobility. The SPPB is comprised of the following tests (balance, walking speed, and chair rise). The scores range from 0 (worst performance) to 12 (best performance). Mobility will also be measured using the GaitRite.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mobility - stair activity</measure>
    <time_frame>18 Months</time_frame>
    <description>A test of ascending and descending stair activity measured by the time (in seconds) it takes to ascend and descend a flight of 8 steps with 20cm (8 inch) step height and handrail will also be performed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Catastrophizing Scale (PCS)</measure>
    <time_frame>18 Months</time_frame>
    <description>The PCS questionnaire will be used to assess catastrophizing (rumination, magnification, and helplessness). The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Lower scores indicate less pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Knee injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>18 Months</time_frame>
    <description>The KOOS questionnaire will be used to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: 1) KOOS Pain; (2) KOOS Symptoms: Other symptoms such as swelling, restricted range of motion and mechanical symptoms; (3) KOOS ADL: Disability on the level of daily activities; (4) KOOS Sport/Rec: Disability on a level physically more demanding than activities of daily living; (5) KOOS QOL: Quality of life, mental and social aspects such as awareness and lifestyle changes. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intermittent and Constant Osteoarthritis Pain (ICOAP)</measure>
    <time_frame>18 Months</time_frame>
    <description>The ICOAP assesses pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences. Individual items are scored from 0 to 4. Each subscale (intermittent pain; constant pain; and total pain) are averaged. Lower numbers indicate lower pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Health Literacy</measure>
    <time_frame>18 Months</time_frame>
    <description>Behavioral Risk Factor Surveillance System measures health literacy. Lower scores indicate higher literacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognitive Functioning</measure>
    <time_frame>18 Months</time_frame>
    <description>The MOCA will be used to measure cognitive function. Scores range 0-30. Higher scores indicate higher cognitive functioning.</description>
  </other_outcome>
  <other_outcome>
    <measure>Brief Resilience Scale</measure>
    <time_frame>18 Months</time_frame>
    <description>The Brief Resilience Scale will be used to measure resilience. The brief resilience scale (BRS) contains 6 items. The BRS is scored by reverse coding negatively worded questions (2, 4, and 6) and finding the mean of the six items. Range= 1-5. Lower scores indicate less resilience.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical Activity</measure>
    <time_frame>18 Months</time_frame>
    <description>Physical activity will be measured by The Physical Activity Scale for the Elderly (PASE). 1-6 are scored in terms of hours per day over a 7-day period. Items 7-12 are scored as 1= engaged in activity or 0=did not engage in activity during the previous seven days. Scores range 0-100. Higher scores indicate more activity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Depression - Center for Epidemiologic Studies Depression Scale (CES-D)</measure>
    <time_frame>18 Months</time_frame>
    <description>Depression will be measured using the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D contains 20-items and measures how often over the past week persons experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Health Related Quality of Life: Euroqol</measure>
    <time_frame>18 Months</time_frame>
    <description>Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on health-related quality of life. The EQ-5D comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Responses results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Osteo Arthritis Knee</condition>
  <arm_group>
    <arm_group_label>Weight-Loss Maintenance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weight Loss Maintenance Intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Education (Attention Control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Health Education Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight-Loss Maintenance</intervention_name>
    <description>Over the course of the first 6-months, participants will build their self-efficacy to maintain weight loss on their own, empowered to do what is needed to achieve personal goals and long-term behavior change (months 7-18). The first 6 months of I-CAN will prepare participants for successful independent weight-loss maintenance in months 7-18. During the 12-month independent weight-loss maintenance phase participants exercise on their own and maintain their weight loss (or increase weight loss if they choose) with the only contact from interventionists being two newsletters at months 9 and 15.</description>
    <arm_group_label>Weight-Loss Maintenance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Education (Attention Control)</intervention_name>
    <description>Participants in the control group will attend an individual session during month 1, and a monthly face-to-face group meeting during months 2-6. The sessions will provide attention, social interaction, and physician-based health education. Participants will receive a newsletter during months 9 and 15.</description>
    <arm_group_label>Health Education (Attention Control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 51&#xD;
&#xD;
          -  achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight loss &lt; 5% of baseline body weight&#xD;
&#xD;
          -  Significant co-morbid disease that would threaten safety or impair ability to&#xD;
             participate in interventions or testing (Blindness; Type 1 diabetes; Severe coronary&#xD;
             artery disease)&#xD;
&#xD;
          -  Inability to finish 18-month study or unlikely to be compliant (Planning to leave area&#xD;
             &gt; 2 month during the next 18 months)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>51 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen P Messier, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leigh Callahan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johnston County - UNC Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haywood County - Haywood Regional Medical Center</name>
      <address>
        <city>Clyde</city>
        <state>North Carolina</state>
        <zip>28721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Forsyth County - Wake Forest University/Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Arthritis</keyword>
  <keyword>Knee</keyword>
  <keyword>weight loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators support data sharing and will comply with all NIH guidelines as outlined in the NIH Data Sharing Policy and Implementation Guidance document. The primary means of data sharing and dissemination will be through scientific publications and presentations. Ensuring patient privacy and confidentiality will be of primary importance in creating the files to be shared. All data files will be de-identified. De-identification procedures will meet HIPAA criteria detailed in the Code of Federal Regulations, Part 46, Section 164.514. The study team will create a link on our website that describes the data files. Documentation will also be provided along with the redacted data files. The documentation will include electronic versions of the protocol, data collection forms (with instructions for scoring, if needed), data dictionary, data code book, labels, and formats. Requests for data will be answered via completion of an online request form and data-sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>All data will be released within three years of completing collection, even if planned papers have not been written or accepted.</ipd_time_frame>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03832296/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03832296
org study id: IRB00033618.I-CAN
nct id: NCT03832296
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study team is currently conducting a pragmatic, community-based assessor-blinded
      randomized controlled trial (RCT) in overweight and obese adults > 50 years with knee OA in
      both urban and rural counties in North Carolina. As the participants randomized to the 18
      month diet and exercise group in the WE-CAN study successfully complete the intervention (≥
      5% weight loss), the study team has the unique opportunity to evaluate the effectiveness of a
      theoretically-based tapered weight maintenance intervention. Eligible participants will be
      randomized to either the weight-loss maintenance or health education attention control
      groups.
Results from the Intensive Diet and Exercise for Arthritis (IDEA) trial showed that 10%
      diet-induced weight loss combined with exercise (D+E) was twice as effective at relieving
      knee pain and improving function and mobility as previous long-term weight loss and exercise
      programs in similar cohorts. The treatment effects of D+E on these clinical outcomes were
      mediated by changes in self-efficacy over the course of the trial. However, most people tend
      to regain most or all of the lost weight in three to five years. The challenge is maintaining
      the weight loss and sustaining the efficacy of the intervention.

      Our current trial (WE-CAN) is designed to adapt the successful IDEA intervention to
      real-world clinical and community settings. As WE-CAN participants in the D+E group complete
      their intervention, the investigators will leverage our organizational infrastructure to
      maintain weight-loss without supervised intervention by increasing participant confidence to
      establish and adhere to a routine of good exercise and diet behaviors independently.

      Participants will include 212 older adults aged ≥ 51 yrs. with knee osteoarthritis (OA) who
      achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial. All WE-CAN
      participants meet the ACR clinical criteria for knee OA, which includes knee pain on most
      days of the week plus at least three of the following six: age ≥ 50 years, stiffness < 30
      min/day, crepitus, bony tenderness, bony enlargement, and/or no palpable warmth. Eligible
      WE-CAN D+E participants will be randomized to either 6-month facilitated weight-loss
      maintenance or health education control interventions. The primary aim is to compare the
      effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory
      to a health education intervention on maintaining weight loss subsequent to a 12-month
      unsupervised follow-up period. Secondary aims will compare the two interventions on WOMAC
      knee pain and function, health-related quality of life (SF-36), 6-minute walk distance, and
      weight-loss maintenance self-efficacy following the 12-month unsupervised period. The study
      team will also establish the cost-effectiveness of a 6-month facilitated weight-loss
      maintenance intervention for older adults with knee OA by conducting cost-effectiveness and
      budgetary impact analyses using data from the current trial in a validated computer-simulated
      model of knee OA.

      There have been numerous attempts to prevent weight regain in adults. This study is
      significant in that it is designed to encourage older adults with knee OA that have
      experienced significant weight loss to develop strategies that will build self-efficacy for
      maintaining weight loss on their own long after the active intervention ends.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will include 212 older adults aged ≥ 51 yrs. with knee OA who achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial. Eligible WE-CAN D+E participants will be randomized to either the weight-loss maintenance or health education attention control groups.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Each eligible participant will be randomized to one of the two arms of the clinical trial (weight-loss maintenance, control) according to a variable block-length algorithm that will be controlled by the Data Management Group. Randomization will be stratified by intervention site to ensure nearly equal sample sizes for the two interventions to balance local population characteristics. Randomization uses a web-based system that is part of the study data management system. Intervention visits will not include any assessments and outcome assessors will remain blinded to group assignment. The lead biostatistician of the Data Management Group will develop the randomization table.
measure: Weight-Loss Maintenance
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on maintaining weight loss subsequent to a 12-month unsupervised follow-up period.
measure: Knee Pain measured by the WOMAC Index
time frame: 18 Months
description: The investigators will measure self-reported pain using the WOMAC (scores will be pulled from the KOOS Questionnaire in which the WOMAC is embedded). The pain index assesses participants' pain on a scale, ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater dysfunction.
measure: Function measured by the WOMAC Index
time frame: 18 Months
description: The investigators will measure self-reported physical function using the WOMAC (scores will be pulled from the KOOS Questionnaire in which the WOMAC is embedded). The LK version asks participants to indicate on a scale from 0 (none) to 4 (extreme) the degree of difficulty experienced in the last week due to knee OA. Individual scores for the 17 items are totaled to generate a summary score that could range from 0-68, with higher scores indicating poorer function.
measure: Health Related Quality of Life: SF-36
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on health-related quality of life (SF-36) subsequent to a 12-month unsupervised follow-up period. Two summary scores are acquired: physical health and mental health. Range=0-100. Higher scores indicate better health.
measure: Mobility- 6 minute walk test
time frame: 18 Months
description: The primary mobility measure will be 6-minute walk distance. Participants are told to walk as far as possible in 6 minutes on an established course.
measure: Self-Efficacy - Perceived Stress: questionnaire
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The perceived stress questionnaire will measure the degree to which people perceive their lives as stressful. Range = 0-40. Higher numbers indicate higher stress.
measure: Self-Efficacy - Walking Efficacy for Duration: walking efficacy for duration scale
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The walking efficacy for duration scale measures one's ability to walk/jog at a moderately fast pace for various durations. Range 0-100. A higher score indicates a higher self-efficacy.
measure: Self-Efficacy - PANAS
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Positive and Negative Affect (PANAS) measures both positive and negative affect, leading to more insightful outlooks regarding participants' feeling states. This scale consists of 20 items that reflect the intensity of how the participant "feels" right now. Range=10-50 for each subscale. A higher score for positive affect indicates a higher level of positive affect. A higher score for negative affect indicates a higher level of negative affect.
measure: Self-Efficacy - Gait Efficacy - gait efficacy/environmental efficacy scale
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The gait efficacy/environmental efficacy scale will ask the participants' confidence in performing certain activities. Confidence in performing activities. Participants will be asked to indicate their level of confidence being able to complete different tasks. Range=0-100. A higher score indicates higher self-efficacy.
measure: Self-Efficacy - Satisfaction with Life: Satisfaction with life scale
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Satisfaction with life scale is focused to assess global life satisfaction. Range=5 to 35. A higher scale indicates a higher level of life satisfaction.
measure: Self-Efficacy - Weight Efficacy Scale
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Weight Efficacy Lifestyle Questionnaire (WEL) is a 20-item measure employed to assess self-efficacy for weight management. Range=0 to 180. Higher numbers indicate better confidence.
measure: Self-Efficacy - Adherence Self Efficacy Scale
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The adherence questionnaire is designed to assess beliefs in one's ability (confidence) to continue exercising at various intensities and frequencies. Range=0-100. A higher score indicates higher self-efficacy.
measure: Self-Efficacy - Barriers Self-Efficacy to Exercise
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Barriers Self-Efficacy to Exercise measures confidence in dealing with barriers to exercise. Range=0-100. Higher numbers indicate higher confidence.
measure: Self-Efficacy - Multidimensional Outcome Expectations for Exercise Scale (MOEES): questionnaire
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The MOEES questionnaire consists of three subscales: physical outcome expectations (score range 6-30), social outcome expectations (score range 4-20), and self-evaluative outcome expectations (score range 5-25). Each subscale is scored by summing the numerical ratings for each response. Higher scores are indicative of higher levels of outcome expectations for exercise.
measure: Self-Efficacy - Perceived Barriers: questionnaire
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The perceived barriers questionnaire measures a person's perceptions to barriers to performing exercise. The questionnaire is scored by finding the mean for each response (range = 1-5). Higher scores indicate higher perception of barriers.
measure: Self-Efficacy - Weight Loss Maintenance: questionnaire
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy for maintaining weight loss. Range=0-100. Higher scores indicate more confidence in maintaining weight loss.
measure: Cost-Effectiveness
time frame: 18 Months
description: Resource utilization will be collected by questionnaire. MD and non-MD office visits will be collected via self-report with domains including visits to clinicians (physicians, nurses, physical therapists, others), tests, medications, injections, surgery, alternative therapies. The number of visits associated with utilization of each of 4 domains, MD visits, non-MD visits, ED visits, and inpatient stays, will be examined.
measure: Cost-Effectiveness- WPAI
time frame: 18 Months
description: The Work Productivity and Activity Impairment index (WPAI) will be used to assess absenteeism and reduced productivity while at work (presenteeism). Outcome (OC) scores can be derived from the WPAI: OC1, percent work time missed due to health, (percentage of absenteeism); percent impairment while working due to health, (percentage of presenteeism); percent overall work impairment due to health, percent activity impairment due to health. For all 4 outcomes, greater scores (range 0-100%) indicate greater impact of health.
measure: Mobility - SPPB & GaitRite
time frame: 18 Months
description: The Short Physical Performance Battery (SPPB) will be used to measure mobility. The SPPB is comprised of the following tests (balance, walking speed, and chair rise). The scores range from 0 (worst performance) to 12 (best performance). Mobility will also be measured using the GaitRite.
measure: Mobility - stair activity
time frame: 18 Months
description: A test of ascending and descending stair activity measured by the time (in seconds) it takes to ascend and descend a flight of 8 steps with 20cm (8 inch) step height and handrail will also be performed.
measure: Pain Catastrophizing Scale (PCS)
time frame: 18 Months
description: The PCS questionnaire will be used to assess catastrophizing (rumination, magnification, and helplessness). The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Lower scores indicate less pain.
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: 18 Months
description: The KOOS questionnaire will be used to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: 1) KOOS Pain; (2) KOOS Symptoms: Other symptoms such as swelling, restricted range of motion and mechanical symptoms; (3) KOOS ADL: Disability on the level of daily activities; (4) KOOS Sport/Rec: Disability on a level physically more demanding than activities of daily living; (5) KOOS QOL: Quality of life, mental and social aspects such as awareness and lifestyle changes. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
measure: Intermittent and Constant Osteoarthritis Pain (ICOAP)
time frame: 18 Months
description: The ICOAP assesses pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences. Individual items are scored from 0 to 4. Each subscale (intermittent pain; constant pain; and total pain) are averaged. Lower numbers indicate lower pain.
measure: Health Literacy
time frame: 18 Months
description: Behavioral Risk Factor Surveillance System measures health literacy. Lower scores indicate higher literacy.
measure: Cognitive Functioning
time frame: 18 Months
description: The MOCA will be used to measure cognitive function. Scores range 0-30. Higher scores indicate higher cognitive functioning.
measure: Brief Resilience Scale
time frame: 18 Months
description: The Brief Resilience Scale will be used to measure resilience. The brief resilience scale (BRS) contains 6 items. The BRS is scored by reverse coding negatively worded questions (2, 4, and 6) and finding the mean of the six items. Range= 1-5. Lower scores indicate less resilience.
measure: Physical Activity
time frame: 18 Months
description: Physical activity will be measured by The Physical Activity Scale for the Elderly (PASE). 1-6 are scored in terms of hours per day over a 7-day period. Items 7-12 are scored as 1= engaged in activity or 0=did not engage in activity during the previous seven days. Scores range 0-100. Higher scores indicate more activity.
measure: Depression - Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: 18 Months
description: Depression will be measured using the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D contains 20-items and measures how often over the past week persons experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
measure: Health Related Quality of Life: Euroqol
time frame: 18 Months
description: Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on health-related quality of life. The EQ-5D comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Responses results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
arm group label: Weight-Loss Maintenance
arm group type: Experimental
description: Weight Loss Maintenance Intervention
arm group label: Health Education (Attention Control)
arm group type: Active Comparator
description: Health Education Intervention
intervention type: Behavioral
intervention name: Weight-Loss Maintenance
description: Over the course of the first 6-months, participants will build their self-efficacy to maintain weight loss on their own, empowered to do what is needed to achieve personal goals and long-term behavior change (months 7-18). The first 6 months of I-CAN will prepare participants for successful independent weight-loss maintenance in months 7-18. During the 12-month independent weight-loss maintenance phase participants exercise on their own and maintain their weight loss (or increase weight loss if they choose) with the only contact from interventionists being two newsletters at months 9 and 15.
arm group label: Weight-Loss Maintenance
intervention type: Behavioral
intervention name: Health Education (Attention Control)
description: Participants in the control group will attend an individual session during month 1, and a monthly face-to-face group meeting during months 2-6. The sessions will provide attention, social interaction, and physician-based health education. Participants will receive a newsletter during months 9 and 15.
arm group label: Health Education (Attention Control)
criteria: 
gender: All
minimum age: 51 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen P Messier, PhD
role: Principal Investigator
affiliation: Wake Forest University
last name: Leigh Callahan, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Weight Loss
sharing ipd: Yes
ipd description: The investigators support data sharing and will comply with all NIH guidelines as outlined in the NIH Data Sharing Policy and Implementation Guidance document. The primary means of data sharing and dissemination will be through scientific publications and presentations. Ensuring patient privacy and confidentiality will be of primary importance in creating the files to be shared. All data files will be de-identified. De-identification procedures will meet HIPAA criteria detailed in the Code of Federal Regulations, Part 46, Section 164.514. The study team will create a link on our website that describes the data files. Documentation will also be provided along with the redacted data files. The documentation will include electronic versions of the protocol, data collection forms (with instructions for scoring, if needed), data dictionary, data code book, labels, and formats. Requests for data will be answered via completion of an online request form and data-sharing agreement.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: All data will be released within three years of completing collection, even if planned papers have not been written or accepted.
provided document: 