<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/NCT02214641</url>
  </required_header>
  <id_info>
    <org_study_id>1K01DK099202-01A1</org_study_id>
    <secondary_id>1K01DK099202-01A1</secondary_id>
    <nct_id>NCT02214641</nct_id>
  </id_info>
  <brief_title>Resilient, Empowered, Active Living: REAL Diabetes Study</brief_title>
  <acronym>REAL</acronym>
  <official_title>Diabetes Self-Management Lifestyle Intervention for Urban Minority Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This three-year award will pilot-test an innovative intervention, Resilient, Empowered,&#xD;
      Active Living with Diabetes (REAL), targeting underserved minority young adults with&#xD;
      poorly-controlled diabetes. The individually tailored, community-based intervention merges&#xD;
      findings of an in-depth needs assessment, principles of an evidence-based occupational&#xD;
      therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management&#xD;
      strategies. A proof-of-concept study demonstrated that REAL is feasible to implement,&#xD;
      acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to&#xD;
      produce positive changes in diabetes self-care and glycemic control. The study will randomize&#xD;
      80 young adults with diabetes to receive either the six-month REAL intervention or an&#xD;
      attention control condition. Blinded data collectors will assess glycemic control, diabetes&#xD;
      self-care behaviors and quality of life outcomes, as well as potential intervention&#xD;
      mediators, before and after the six-month intervention. It is anticipated that findings from&#xD;
      this pilot study will be used to inform a large-scale randomized controlled trial of the REAL&#xD;
      intervention.&#xD;
&#xD;
      The study's specific aims and hypotheses are as follows:&#xD;
&#xD;
      Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and&#xD;
      diabetes self-care.&#xD;
&#xD;
      Hypothesis: At 6 months (immediately following the intervention), intervention group&#xD;
      participants will demonstrate improvements in A1C and diabetes self-care as compared to&#xD;
      control group participants.&#xD;
&#xD;
      Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and&#xD;
      potential mediating mechanisms (to inform power estimates for a large-scale RCT).&#xD;
&#xD;
      Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in&#xD;
      secondary outcomes: diabetes-related stress and quality of life, depression, and life&#xD;
      satisfaction as compared to control group participants.&#xD;
&#xD;
      Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in&#xD;
      potential mediators of the intervention: habit strength, problem solving, activity&#xD;
      participation, self-efficacy and diabetes knowledge as compared to baseline.&#xD;
&#xD;
      Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine&#xD;
      intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures&#xD;
      (e.g. recruitment, retention, testing protocol).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Glycated hemoglobin (HbA1C)</measure>
    <time_frame>Baseline &amp; 6 months.</time_frame>
    <description>Measure of average blood glucose concentration over approximately the previous 12 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Audit of Diabetes-Dependent Quality of Life (ADD-QoL)</measure>
    <time_frame>Baseline &amp; 6 months.</time_frame>
    <description>19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Problem Areas in Diabetes (PAID) Scale - Short Form</measure>
    <time_frame>Baseline &amp; 6 months.</time_frame>
    <description>5-item survey measure assessing diabetes-related distress and emotional problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-8 (PHQ-8)</measure>
    <time_frame>Baseline &amp; 6 months</time_frame>
    <description>8-item survey measure assessing severity of depressive symptoms (identical to PHQ-9 while omitting self-harm item).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Life Scale (SWLS)</measure>
    <time_frame>Baseline &amp; 6 months.</time_frame>
    <description>5-item survey measure assessing global life satisfaction and subjective well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary of Diabetes Self-Care Activities (SDSCA)</measure>
    <time_frame>Baseline &amp; 6 months</time_frame>
    <description>14 items assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Lifestyle intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resilient, Empowered, Active Living (REAL) Diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Information Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resilient, Empowered, Active Living with Diabetes</intervention_name>
    <description>Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive a total of 10-16 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the REAL Diabetes intervention protocol.</description>
    <arm_group_label>Lifestyle intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Information Control</intervention_name>
    <description>Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose. The packet of materials will be delivered in an initial home visit. Follow-up phone calls will occur at approximately two week intervals to inquire whether participants have reviewed specific sections of the intervention materials, and clarify information included in the packet.</description>
    <arm_group_label>Information Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with type 1 or type 2 diabetes mellitus for a minimum of 12 months&#xD;
&#xD;
          -  Most recent A1C ≥8.0%&#xD;
&#xD;
          -  Fluent in English or Spanish&#xD;
&#xD;
          -  Reachable by telephone or text message&#xD;
&#xD;
          -  Willing to participate in study activities&#xD;
&#xD;
          -  Reside in Los Angeles County with no plans to relocate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or planning to become pregnant&#xD;
&#xD;
          -  Cognitive impairment or severe disability limiting life expectancy&#xD;
&#xD;
          -  Participated in lifestyle intervention targeting diabetes within past 12 months&#xD;
&#xD;
          -  Participated in formative research related to intervention development.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Pyatak, PhD, OTR/L</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Pyatak EA, Florindez D, Peters AL, Weigensberg MJ. &quot;We are all gonna get diabetic these days&quot;: the impact of a living legacy of type 2 diabetes on Hispanic young adults' diabetes care. Diabetes Educ. 2014 Sep-Oct;40(5):648-58. doi: 10.1177/0145721714535994. Epub 2014 May 27.</citation>
    <PMID>24867918</PMID>
  </reference>
  <reference>
    <citation>Pyatak EA, Sequeira PA, Whittemore R, Vigen CP, Peters AL, Weigensberg MJ. Challenges contributing to disrupted transition from paediatric to adult diabetes care in young adults with type 1 diabetes. Diabet Med. 2014 Dec;31(12):1615-24. doi: 10.1111/dme.12485. Epub 2014 May 26.</citation>
    <PMID>24798586</PMID>
  </reference>
  <reference>
    <citation>Pyatak EA, Florindez D, Weigensberg MJ. Adherence decision making in the everyday lives of emerging adults with type 1 diabetes. Patient Prefer Adherence. 2013 Jul 29;7:709-18. doi: 10.2147/PPA.S47577. Print 2013.</citation>
    <PMID>23935361</PMID>
  </reference>
  <reference>
    <citation>Pyatak EA, Carandang K, Davis S. Developing a Manualized Occupational Therapy Diabetes Management Intervention: Resilient, Empowered, Active Living With Diabetes. OTJR (Thorofare N J). 2015 Jul;35(3):187-94. doi: 10.1177/1539449215584310.</citation>
    <PMID>26594741</PMID>
  </reference>
  <reference>
    <citation>Pyatak EA, Carandang K, Vigen C, Blanchard J, Sequeira PA, Wood JR, Spruijt-Metz D, Whittemore R, Peters AL. Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults. Contemp Clin Trials. 2017 Mar;54:8-17. doi: 10.1016/j.cct.2016.12.025. Epub 2017 Jan 5.</citation>
    <PMID>28064028</PMID>
  </reference>
  <reference>
    <citation>Vigen CLP, Carandang K, Blanchard J, Sequeira PA, Wood JR, Spruijt-Metz D, Whittemore R, Peters AL, Pyatak EA. Psychosocial and Behavioral Correlates of A1C and Quality of Life Among Young Adults With Diabetes. Diabetes Educ. 2018 Dec;44(6):489-500. doi: 10.1177/0145721718804170. Epub 2018 Oct 8.</citation>
    <PMID>30295170</PMID>
  </reference>
  <reference>
    <citation>Carandang KM, Pyatak EA. Feasibility of a Manualized Occupation-Based Diabetes Management Intervention. Am J Occup Ther. 2018 Mar/Apr;72(2):7202345040p1-7202345040p6. doi: 10.5014/ajot.2018.021790.</citation>
    <PMID>29426394</PMID>
  </reference>
  <results_reference>
    <citation>Pyatak EA, Carandang K, Vigen CLP, Blanchard J, Diaz J, Concha-Chavez A, Sequeira PA, Wood JR, Whittemore R, Spruijt-Metz D, Peters AL. Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial. Diabetes Care. 2018 Apr;41(4):696-704. doi: 10.2337/dc17-1634. Epub 2018 Jan 19.</citation>
    <PMID>29351961</PMID>
  </results_reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Beth Pyatak</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</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/NCT02214641
org study id: 1K01DK099202-01A1
secondary id: 1K01DK099202-01A1
nct id: NCT02214641
lead sponsor: 
collaborator: 
has dmc: Yes
This three-year award will pilot-test an innovative intervention, Resilient, Empowered,
      Active Living with Diabetes (REAL), targeting underserved minority young adults with
      poorly-controlled diabetes. The individually tailored, community-based intervention merges
      findings of an in-depth needs assessment, principles of an evidence-based occupational
      therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management
      strategies. A proof-of-concept study demonstrated that REAL is feasible to implement,
      acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to
      produce positive changes in diabetes self-care and glycemic control. The study will randomize
      80 young adults with diabetes to receive either the six-month REAL intervention or an
      attention control condition. Blinded data collectors will assess glycemic control, diabetes
      self-care behaviors and quality of life outcomes, as well as potential intervention
      mediators, before and after the six-month intervention. It is anticipated that findings from
      this pilot study will be used to inform a large-scale randomized controlled trial of the REAL
      intervention.

      The study's specific aims and hypotheses are as follows:

      Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and
      diabetes self-care.

      Hypothesis: At 6 months (immediately following the intervention), intervention group
      participants will demonstrate improvements in A1C and diabetes self-care as compared to
      control group participants.

      Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and
      potential mediating mechanisms (to inform power estimates for a large-scale RCT).

      Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in
      secondary outcomes: diabetes-related stress and quality of life, depression, and life
      satisfaction as compared to control group participants.

      Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in
      potential mediators of the intervention: habit strength, problem solving, activity
      participation, self-efficacy and diabetes knowledge as compared to baseline.

      Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine
      intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures
      (e.g. recruitment, retention, testing protocol).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Glycated hemoglobin (HbA1C)
time frame: Baseline & 6 months.
description: Measure of average blood glucose concentration over approximately the previous 12 weeks.
measure: Audit of Diabetes-Dependent Quality of Life (ADD-QoL)
time frame: Baseline & 6 months.
description: 19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning.
measure: Problem Areas in Diabetes (PAID) Scale - Short Form
time frame: Baseline & 6 months.
description: 5-item survey measure assessing diabetes-related distress and emotional problems.
measure: Patient Health Questionnaire-8 (PHQ-8)
time frame: Baseline & 6 months
description: 8-item survey measure assessing severity of depressive symptoms (identical to PHQ-9 while omitting self-harm item).
measure: Satisfaction With Life Scale (SWLS)
time frame: Baseline & 6 months.
description: 5-item survey measure assessing global life satisfaction and subjective well-being.
measure: Summary of Diabetes Self-Care Activities (SDSCA)
time frame: Baseline & 6 months
description: 14 items assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes.
arm group label: Lifestyle intervention
arm group type: Experimental
description: Resilient, Empowered, Active Living (REAL) Diabetes
arm group label: Information Control
arm group type: Active Comparator
description: Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose.
intervention type: Behavioral
intervention name: Resilient, Empowered, Active Living with Diabetes
description: Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive a total of 10-16 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the REAL Diabetes intervention protocol.
arm group label: Lifestyle intervention
intervention type: Behavioral
intervention name: Information Control
description: Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose. The packet of materials will be delivered in an initial home visit. Follow-up phone calls will occur at approximately two week intervals to inquire whether participants have reviewed specific sections of the intervention materials, and clarify information included in the packet.
arm group label: Information Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
last name: Elizabeth Pyatak, PhD, OTR/L
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
citation: Pyatak EA, Florindez D, Peters AL, Weigensberg MJ. "We are all gonna get diabetic these days": the impact of a living legacy of type 2 diabetes on Hispanic young adults' diabetes care. Diabetes Educ. 2014 Sep-Oct;40(5):648-58. doi: 10.1177/0145721714535994. Epub 2014 May 27.
PMID: 24867918
citation: Pyatak EA, Sequeira PA, Whittemore R, Vigen CP, Peters AL, Weigensberg MJ. Challenges contributing to disrupted transition from paediatric to adult diabetes care in young adults with type 1 diabetes. Diabet Med. 2014 Dec;31(12):1615-24. doi: 10.1111/dme.12485. Epub 2014 May 26.
PMID: 24798586
citation: Pyatak EA, Florindez D, Weigensberg MJ. Adherence decision making in the everyday lives of emerging adults with type 1 diabetes. Patient Prefer Adherence. 2013 Jul 29;7:709-18. doi: 10.2147/PPA.S47577. Print 2013.
PMID: 23935361
citation: Pyatak EA, Carandang K, Davis S. Developing a Manualized Occupational Therapy Diabetes Management Intervention: Resilient, Empowered, Active Living With Diabetes. OTJR (Thorofare N J). 2015 Jul;35(3):187-94. doi: 10.1177/1539449215584310.
PMID: 26594741
citation: Pyatak EA, Carandang K, Vigen C, Blanchard J, Sequeira PA, Wood JR, Spruijt-Metz D, Whittemore R, Peters AL. Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults. Contemp Clin Trials. 2017 Mar;54:8-17. doi: 10.1016/j.cct.2016.12.025. Epub 2017 Jan 5.
PMID: 28064028
citation: Vigen CLP, Carandang K, Blanchard J, Sequeira PA, Wood JR, Spruijt-Metz D, Whittemore R, Peters AL, Pyatak EA. Psychosocial and Behavioral Correlates of A1C and Quality of Life Among Young Adults With Diabetes. Diabetes Educ. 2018 Dec;44(6):489-500. doi: 10.1177/0145721718804170. Epub 2018 Oct 8.
PMID: 30295170
citation: Carandang KM, Pyatak EA. Feasibility of a Manualized Occupation-Based Diabetes Management Intervention. Am J Occup Ther. 2018 Mar/Apr;72(2):7202345040p1-7202345040p6. doi: 10.5014/ajot.2018.021790.
PMID: 29426394
citation: Pyatak EA, Carandang K, Vigen CLP, Blanchard J, Diaz J, Concha-Chavez A, Sequeira PA, Wood JR, Whittemore R, Spruijt-Metz D, Peters AL. Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial. Diabetes Care. 2018 Apr;41(4):696-704. doi: 10.2337/dc17-1634. Epub 2018 Jan 19.
PMID: 29351961
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Beth Pyatak
investigator title: Associate Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Diabetes Mellitus, Type 1