<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/NCT03001999</url>
  </required_header>
  <id_info>
    <org_study_id>2016P002523</org_study_id>
    <nct_id>NCT03001999</nct_id>
  </id_info>
  <brief_title>Boosting Emotions &amp; Happiness in Outpatients Living With Diabetes: Phase I</brief_title>
  <acronym>BEHOLD-16</acronym>
  <official_title>A Novel Psychological-behavioral Intervention to Improve Activity in Type 2 Diabetes: Proof-of-concept Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Diabetes Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The focus of this study is to examine the feasibility, acceptability, and preliminary impact&#xD;
      of a customized, combined positive psychology and motivational interviewing (PP-MI) health&#xD;
      behavior intervention in a group of patients with type 2 diabetes (T2D).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are proposing a study that will specifically and innovatively focus on the&#xD;
      development of a novel positive psychology intervention that is adapted for patients with&#xD;
      T2D. The MGH Diabetes Center and MGH primary care clinics will serve as the source of&#xD;
      subjects for the study, with patients who have a diagnosis of T2D serving as potential&#xD;
      subjects. The investigators will enroll 12 T2D patients, who will take part in an 16-week&#xD;
      PP-MI health behavior intervention.&#xD;
&#xD;
      In this project, the investigators plan to do the following:&#xD;
&#xD;
        1. Test a 16-week, telephone-delivered health behavior intervention utilizing PP exercises&#xD;
           and systematic goal-setting in a brief, non-randomized, proof-of concept trial (N=12).&#xD;
&#xD;
        2. Determine whether this initial intervention is feasible in a small cohort of T2D&#xD;
           patients.&#xD;
&#xD;
        3. Explore potential benefits of the intervention on outcomes of interest (e.g., optimism,&#xD;
           positive affect).&#xD;
&#xD;
      Baseline information about enrolled participants will be obtained from the patients, care&#xD;
      providers, and the electronic medical record as required for characterization of the&#xD;
      population. This information will include data regarding medical history (type 2 diabetes&#xD;
      mellitus), current medical variables (conditions affecting physical activity), medications,&#xD;
      and sociodemographic data (age, gender, race/ethnicity, living alone).&#xD;
&#xD;
      Participants will undergo an initial screening visit during which they will meet with study&#xD;
      staff in person. At this visit, study eligibility will be confirmed, and eligible and willing&#xD;
      participants will be enrolled. Following enrollment, participants will complete self-report&#xD;
      measures, and nurses in the Translational and Clinical Research Center will collect vital&#xD;
      signs and draw blood for A1c. To ensure that participants have low baseline physical&#xD;
      activity, they will then take home and wear accelerometers for 1 week.&#xD;
&#xD;
      Participants will undergo a second in-person visit to confirm that participants are eligible&#xD;
      to complete the program and--if so--to initiate the program. During this session, A1c and&#xD;
      accelerometer data will be reviewed. Participants will be required to have an A1c value&#xD;
      between 6.5% and 9%, unless they have had an eligible A1c level in the past 6 months, in&#xD;
      which case their current A1c may be between 6% and 9.5%. Furthermore, participants must have&#xD;
      low physical activity (&lt; 75 minutes of moderate or vigorous physical activity over the past&#xD;
      week, measured by accelerometer) to continue in the program. Upon confirmation of&#xD;
      eligibility, participants will begin the study intervention.&#xD;
&#xD;
      During this second in-person visit, participants will receive a PP-MI treatment manual. For&#xD;
      each session, a PP exercise will be described in the manual, with instructions and space to&#xD;
      write about the exercise and its effects. Next, an MI section will outline specific MI-based&#xD;
      topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting.&#xD;
      Interventionists will complete PP exercise 1 and MI session 1 together with participants to&#xD;
      aid engagement. Interventionists will also explain/assign PP exercise 2 and discuss an&#xD;
      MI-based activity goal matched to participants' stage of change and medical recommendations&#xD;
      (and assign activity tracking).&#xD;
&#xD;
      Participants will complete the remaining sessions (14 in total) by phone over the next 16&#xD;
      weeks. Phone sessions will last for approximately 30 minutes, with PP and physical activity&#xD;
      assignments completed between phone sessions. PP and MI components will be delivered stepwise&#xD;
      within sessions (rather than intertwined) based on our experience, participant feedback, and&#xD;
      pilot work. If a week is missed, the session will not be skipped, but rather the intervention&#xD;
      will be completed sequentially (with participants who miss weeks then missing the final&#xD;
      sessions), with the exception of the final visit, which skip to Planning for the Future in&#xD;
      all cases.&#xD;
&#xD;
      Participants will undergo an in-person follow-up assessment at 16 weeks. At this session,&#xD;
      participants will repeat self-report assessments that were administered at baseline. Vital&#xD;
      signs and a blood sample will again be collected at this final in-person visit. Finally,&#xD;
      prior to this assessment, participants will wear an accelerometer for an additional 7 days to&#xD;
      measure moderate or vigorous physical activity. The investigators will allow a window of 3&#xD;
      weeks, to allow flexibility of scheduling such in-person appointments in Boston (and to allow&#xD;
      coordination with other medical visits at MGH) while maintaining integrity of study findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of recruitment procedures</measure>
    <time_frame>Change between baseline and 16 weeks</time_frame>
    <description>Feasibility will be measured by rates of enrollment per month.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of study procedures</measure>
    <time_frame>Change between baseline and 16 weeks</time_frame>
    <description>Feasibility will also be measured by rates of dropout (%of total enrolled).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of intervention exercises</measure>
    <time_frame>Change between baseline and 16 weeks</time_frame>
    <description>Feasibility of intervention exercises will be measured by rates of completion of exercises.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of intervention</measure>
    <time_frame>Change between baseline and 16 weeks</time_frame>
    <description>Ease of the intervention will also be measured by patient rating of the ease of PP-MI sessions on a 10-point Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility of intervention</measure>
    <time_frame>Change between baseline and 16 weeks</time_frame>
    <description>Utility of the intervention will also be measured by patient rating of the utility of PP-MI sessions on a 10-point Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Moderate-Vigorous Physical activity</measure>
    <time_frame>Change between baseline and 16 weeks</time_frame>
    <description>Physical activity changes will be measured by MVPA in mean minutes per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedentary Time</measure>
    <time_frame>Change between baseline and 16 weeks</time_frame>
    <description>Sedentary time will be measured in mean minutes per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in PANAS Scores</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in LOT-R Scores</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in HADS Scores</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in SEE Scores</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The Self-Efficacy for Exercise scale will be used to identify factors that may affect participation in exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in RS Scores</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The Resilience Scale will be used to examine the impact of the intervention on resilience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in MSPSS Scores</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The Multidimensional Scale of Perceived Social Support will be used to assess the intervention's impact on perceived social support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in SDSCA Scores</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The Summary of Diabetes Self-Care Activities will be used to evaluate overall diabetes self-care (e.g., diet, medication, foot care).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in T2D medication adherence</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The investigators will use a %-based self-report measure to gain estimates of T2D medication adherence.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in IPAQ Scores</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The International Physical Activity Questionnaires will be used to assess changes in physical activity over the course of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in PF-20 Scores</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The 20-item short form of the Patient-Reported Outcomes Measurement Information System (PROMIS) will be used to assess physical function.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in PDI Scores</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>The Pain Disability Index will be used to assess pain-related disability.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Audit-C Questionnaire Responses</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>This questionnaire will be used to assess changes in alcohol consumption over the course of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Cigarette Use Questionnaire</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>This questionnaire will be used to assess changes in cigarette use over the course of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Weight</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Patients will have their blood drawn at baseline and 16 weeks so that the investigators can obtain and assess their A1C level over the course of the study.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Emotions</condition>
  <condition>Patient Compliance</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will all undergo a 16-week PP-MI health behavior intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PP-MI health behavior intervention</intervention_name>
    <description>The positive psychology exercises include 3 modules:&#xD;
Gratitude-based activities, Strength-based activities, and Meaning-based activities. Various goal setting exercises will appear in each of the 14 study sessions.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  T2D. Eligible patients will be diagnosed with T2D, with diagnosis for at least 1 year,&#xD;
             confirmed by their diabetes clinician or medical record review. Consistent with&#xD;
             American Diabetes Association (ADA) criteria for T2D, participants must have HbA1c&#xD;
             [A1C] of at least 6.5% within the last 6 months. The investigators will exclude&#xD;
             patients with A1C&gt;9% given that patients in this range will likely have more extreme&#xD;
             nonadherence and/or require ongoing treatment adjustment, increasing the heterogeneity&#xD;
             of this sample for this pilot project. If patients appear otherwise eligible, but do&#xD;
             not have an A1C value within 6 months, they will be required to have a baseline A1C&#xD;
             value of 6.5-9%.&#xD;
&#xD;
          -  Low physical activity. The investigators will define low physical activity as ≤75&#xD;
             minutes/week of MVPA (representing ≤40% of ADA recommendations for moderate or greater&#xD;
             intensity aerobic physical activity totaling 150 minutes per week). This cutoff allows&#xD;
             adequate room for improvement on this key outcome. As an initial screen, the&#xD;
             investigators will use a modified version of the International Physical Activity&#xD;
             Questionnaire (IPAQ) which has been extensively used/validated in medical cohorts,&#xD;
             including T2D. Patients will complete the modified IPAQ regarding their activity in&#xD;
             the past week (or a typical week, if the past 7 days atypical) to assess number of&#xD;
             minutes spent performing MVPA. Patients reporting ≤60 minutes/week of MVPA will then&#xD;
             wear accelerometers for 7 days to confirm low physical activity.&#xD;
&#xD;
          -  Prescribed an oral glucose-lowering drug or choosing lifestyle interventions (diet and&#xD;
             exercise) to manage T2D. To be eligible, patients must be prescribed a stable&#xD;
             glucose-lowering medication regimen (or stable plan for control with diet/exercise&#xD;
             alone) for at least 3 months with no anticipated adjustment. Including those whose T2D&#xD;
             is managed by diet and exercise alone will allow inclusion of participants who may&#xD;
             have high likelihood of engagement in a behavioral intervention. The investigators&#xD;
             will exclude patients taking insulin to reduce heterogeneity of T2D severity in this&#xD;
             initial trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment precluding consent or meaningful participation, assessed using a&#xD;
             six-item screen developed for this purpose.&#xD;
&#xD;
          -  Lack of phone availability.&#xD;
&#xD;
          -  Inability to read/write in English.&#xD;
&#xD;
          -  Additional medical conditions (e.g., severe arthritis, chronic pulmonary obstructive&#xD;
             disease, class III or IV heart failure) that preclude physical activity.&#xD;
&#xD;
          -  Enrollment in mind-body programs, lifestyle intervention programs (e.g., cardiac&#xD;
             rehabilitation), or other clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeff C Huffman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</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 23, 2016</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Jeff C. Huffman, MD</investigator_full_name>
    <investigator_title>Associate Professor in Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Positive Psychology</keyword>
  <keyword>Physical Activity</keyword>
  <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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03001999
org study id: 2016P002523
nct id: NCT03001999
lead sponsor: 
collaborator: 
has dmc: Yes
The focus of this study is to examine the feasibility, acceptability, and preliminary impact
      of a customized, combined positive psychology and motivational interviewing (PP-MI) health
      behavior intervention in a group of patients with type 2 diabetes (T2D).
The investigators are proposing a study that will specifically and innovatively focus on the
      development of a novel positive psychology intervention that is adapted for patients with
      T2D. The MGH Diabetes Center and MGH primary care clinics will serve as the source of
      subjects for the study, with patients who have a diagnosis of T2D serving as potential
      subjects. The investigators will enroll 12 T2D patients, who will take part in an 16-week
      PP-MI health behavior intervention.

      In this project, the investigators plan to do the following:

        1. Test a 16-week, telephone-delivered health behavior intervention utilizing PP exercises
           and systematic goal-setting in a brief, non-randomized, proof-of concept trial (N=12).

        2. Determine whether this initial intervention is feasible in a small cohort of T2D
           patients.

        3. Explore potential benefits of the intervention on outcomes of interest (e.g., optimism,
           positive affect).

      Baseline information about enrolled participants will be obtained from the patients, care
      providers, and the electronic medical record as required for characterization of the
      population. This information will include data regarding medical history (type 2 diabetes
      mellitus), current medical variables (conditions affecting physical activity), medications,
      and sociodemographic data (age, gender, race/ethnicity, living alone).

      Participants will undergo an initial screening visit during which they will meet with study
      staff in person. At this visit, study eligibility will be confirmed, and eligible and willing
      participants will be enrolled. Following enrollment, participants will complete self-report
      measures, and nurses in the Translational and Clinical Research Center will collect vital
      signs and draw blood for A1c. To ensure that participants have low baseline physical
      activity, they will then take home and wear accelerometers for 1 week.

      Participants will undergo a second in-person visit to confirm that participants are eligible
      to complete the program and--if so--to initiate the program. During this session, A1c and
      accelerometer data will be reviewed. Participants will be required to have an A1c value
      between 6.5% and 9%, unless they have had an eligible A1c level in the past 6 months, in
      which case their current A1c may be between 6% and 9.5%. Furthermore, participants must have
      low physical activity (< 75 minutes of moderate or vigorous physical activity over the past
      week, measured by accelerometer) to continue in the program. Upon confirmation of
      eligibility, participants will begin the study intervention.

      During this second in-person visit, participants will receive a PP-MI treatment manual. For
      each session, a PP exercise will be described in the manual, with instructions and space to
      write about the exercise and its effects. Next, an MI section will outline specific MI-based
      topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting.
      Interventionists will complete PP exercise 1 and MI session 1 together with participants to
      aid engagement. Interventionists will also explain/assign PP exercise 2 and discuss an
      MI-based activity goal matched to participants' stage of change and medical recommendations
      (and assign activity tracking).

      Participants will complete the remaining sessions (14 in total) by phone over the next 16
      weeks. Phone sessions will last for approximately 30 minutes, with PP and physical activity
      assignments completed between phone sessions. PP and MI components will be delivered stepwise
      within sessions (rather than intertwined) based on our experience, participant feedback, and
      pilot work. If a week is missed, the session will not be skipped, but rather the intervention
      will be completed sequentially (with participants who miss weeks then missing the final
      sessions), with the exception of the final visit, which skip to Planning for the Future in
      all cases.

      Participants will undergo an in-person follow-up assessment at 16 weeks. At this session,
      participants will repeat self-report assessments that were administered at baseline. Vital
      signs and a blood sample will again be collected at this final in-person visit. Finally,
      prior to this assessment, participants will wear an accelerometer for an additional 7 days to
      measure moderate or vigorous physical activity. The investigators will allow a window of 3
      weeks, to allow flexibility of scheduling such in-person appointments in Boston (and to allow
      coordination with other medical visits at MGH) while maintaining integrity of study findings.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility of recruitment procedures
time frame: Change between baseline and 16 weeks
description: Feasibility will be measured by rates of enrollment per month.
measure: Feasibility of study procedures
time frame: Change between baseline and 16 weeks
description: Feasibility will also be measured by rates of dropout (%of total enrolled).
measure: Feasibility of intervention exercises
time frame: Change between baseline and 16 weeks
description: Feasibility of intervention exercises will be measured by rates of completion of exercises.
measure: Ease of intervention
time frame: Change between baseline and 16 weeks
description: Ease of the intervention will also be measured by patient rating of the ease of PP-MI sessions on a 10-point Likert scale.
measure: Utility of intervention
time frame: Change between baseline and 16 weeks
description: Utility of the intervention will also be measured by patient rating of the utility of PP-MI sessions on a 10-point Likert scale.
measure: Moderate-Vigorous Physical activity
time frame: Change between baseline and 16 weeks
description: Physical activity changes will be measured by MVPA in mean minutes per day.
measure: Sedentary Time
time frame: Change between baseline and 16 weeks
description: Sedentary time will be measured in mean minutes per day.
measure: Changes in PANAS Scores
time frame: Baseline and 16 weeks
description: The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect.
measure: Changes in LOT-R Scores
time frame: Baseline and 16 weeks
description: Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism.
measure: Changes in HADS Scores
time frame: Baseline and 16 weeks
description: The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.
measure: Changes in SEE Scores
time frame: Baseline and 16 weeks
description: The Self-Efficacy for Exercise scale will be used to identify factors that may affect participation in exercise.
measure: Changes in RS Scores
time frame: Baseline and 16 weeks
description: The Resilience Scale will be used to examine the impact of the intervention on resilience.
measure: Changes in MSPSS Scores
time frame: Baseline and 16 weeks
description: The Multidimensional Scale of Perceived Social Support will be used to assess the intervention's impact on perceived social support.
measure: Changes in SDSCA Scores
time frame: Baseline and 16 weeks
description: The Summary of Diabetes Self-Care Activities will be used to evaluate overall diabetes self-care (e.g., diet, medication, foot care).
measure: Changes in T2D medication adherence
time frame: Baseline and 16 weeks
description: The investigators will use a %-based self-report measure to gain estimates of T2D medication adherence.
measure: Changes in IPAQ Scores
time frame: Baseline and 16 weeks
description: The International Physical Activity Questionnaires will be used to assess changes in physical activity over the course of the study.
measure: Changes in PF-20 Scores
time frame: Baseline and 16 weeks
description: The 20-item short form of the Patient-Reported Outcomes Measurement Information System (PROMIS) will be used to assess physical function.
measure: Changes in PDI Scores
time frame: Baseline and 16 weeks
description: The Pain Disability Index will be used to assess pain-related disability.
measure: Changes in Audit-C Questionnaire Responses
time frame: Baseline and 16 weeks
description: This questionnaire will be used to assess changes in alcohol consumption over the course of the study.
measure: Changes in Cigarette Use Questionnaire
time frame: Baseline and 16 weeks
description: This questionnaire will be used to assess changes in cigarette use over the course of the study.
measure: Blood pressure
time frame: Baseline and 16 weeks
measure: Weight
time frame: Baseline and 16 weeks
measure: Body mass index (BMI)
time frame: Baseline and 16 weeks
measure: Hemoglobin A1c
time frame: Baseline and 16 weeks
description: Patients will have their blood drawn at baseline and 16 weeks so that the investigators can obtain and assess their A1C level over the course of the study.
arm group label: Intervention Arm
arm group type: Experimental
description: Participants will all undergo a 16-week PP-MI health behavior intervention.
intervention type: Behavioral
intervention name: PP-MI health behavior intervention
description: The positive psychology exercises include 3 modules:
Gratitude-based activities, Strength-based activities, and Meaning-based activities. Various goal setting exercises will appear in each of the 14 study sessions.
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeff C Huffman, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Jeff C. Huffman, MD
investigator title: Associate Professor in Psychiatry
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided