<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/NCT03307187</url>
  </required_header>
  <id_info>
    <org_study_id>015-049</org_study_id>
    <nct_id>NCT03307187</nct_id>
  </id_info>
  <brief_title>Group Lifestyle Balance Adapted for Individuals With Impaired Mobility (GLB-AIM)</brief_title>
  <acronym>GLB-AIM</acronym>
  <official_title>Group Lifestyle Balance Adapted for Impaired Mobility (GLB-AIM): Translating the GLB to Promote Healthy Weight in People With Mobility Disability (Impairment)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor Research Institute</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>
      This study tested the effectiveness of the Group Lifestyle Balance™ (GLB) program adapted&#xD;
      specifically for people with impaired mobility using standard behavioral approaches for&#xD;
      weight loss. The overarching aim of this study was to promote health and reduce chronic&#xD;
      disease risk among people with mobility impairment by building an evidence base for weight&#xD;
      loss. The central hypothesis was that participants randomized to the intervention arm of the&#xD;
      adapted GLB would show significant improvements on primary outcomes of weight and PA compared&#xD;
      to a 6-month wait-list control group at 3 and 6 months, and show improvements on several&#xD;
      secondary health outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The following are the specific study aims and hypotheses:&#xD;
&#xD;
      Aim 1: To create an appropriate and usable adaptation of the GLB program for people with&#xD;
      mobility impairment.&#xD;
&#xD;
      Hypothesis 1.1: Advisory board participants will identify key adaptations to make the GLB&#xD;
      materials appropriate and usable for individuals with impaired mobility.&#xD;
&#xD;
      Aim 2: To establish whether the adapted GLB program for people with mobility impairment is a&#xD;
      feasible intervention.&#xD;
&#xD;
      Hypothesis 2.1: Intervention participants will rate the program satisfactorily and attend at&#xD;
      least 2/3rd of the weekly group-based meetings and monthly individualized phone calls.&#xD;
      Lifestyle coaches will also rate the adapted program satisfactorily.&#xD;
&#xD;
      Aim 3: To determine if the GLB intervention adapted for those with mobility impairment is&#xD;
      effective as determined by significant improvement in the primary and secondary outcomes in&#xD;
      the intervention group compared to the wait-list control group at 3 and 6 months from&#xD;
      baseline.&#xD;
&#xD;
      Hypothesis 3.1: The intervention group will demonstrate significantly greater improvements in&#xD;
      our primary outcomes (weight and PA) than the wait list control group at 3 and at 6 months&#xD;
      and will show significant improvements in secondary outcomes at 6 months. Hypothesis 3.2:&#xD;
      Both groups combined will demonstrate significantly greater improvements in the primary&#xD;
      outcomes (weight and PA) after 3, 6 and 12 months of intervention and secondary outcomes&#xD;
      after 6 and 12 months of intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>weight change</measure>
    <time_frame>12 months</time_frame>
    <description>change in weight collected on 4 times over the year. Weight was measured using a Seca accessible scale (#676); wheelchair users were weighed in their chair on the scale, then transferred to a PT mat table from their chair scale to have their chair weighted separately and body weight was calculated as wheelchair weight subtracted from total weight.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Session Attendance</measure>
    <time_frame>12 months</time_frame>
    <description>Session attendance recorded for each of the 23 sessions and reported as average attendance at each session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self-monitoring</measure>
    <time_frame>over 13 core weeks</time_frame>
    <description>self-monitoring adherence for daily food intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical activity</measure>
    <time_frame>baseline, 3, 6, and 12 months</time_frame>
    <description>self reported physical activity reported on the brief International Physical Activity Questionaire as minutes per week spent in moderate-intensity activity, vigorous-intensity activity, moderate and vigorous activity combined, and minutes per week walking/wheeling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>waist circumference</measure>
    <time_frame>baseline, 6, and 12 months</time_frame>
    <description>waist circumference measured while participants laid supine on a PT mat table at the level of the umbilicus, using a fabric measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemoglobin A1c</measure>
    <time_frame>baseline, 6, and 12 months</time_frame>
    <description>hemoglobin A1c was collected by blood draw and sent to the lab for analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>baseline, 6, and 12 months</time_frame>
    <description>resting blood pressure after sitting quietly for 10 minutes using an Omron 3 Series wrist worm blood pressure cuff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cholesterol</measure>
    <time_frame>baseline, 3, 6, and 12 months</time_frame>
    <description>total cholesterol was collected by blood draw during the non-fasting state and sent to the lab for analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self-efficacy</measure>
    <time_frame>baseline, 3, 6, and 12 months</time_frame>
    <description>self-efficacy for health promoting behaviors: 27-items of the Self-Rated Abilities for Health Practices scale which assesses participants perceived ability to engage in health promoting activities across 4 domains (Nutrition, Exercise, Health Practices, Psychological Well Being, plus a total self-efficacy score)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Mobility Limitation</condition>
  <arm_group>
    <arm_group_label>GLB-AIM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GLB-AIM (Group Lifestyle Balance program, Adapted for individuals with Impaired Mobility) is a 12-month intervention that promotes 5% weight loss by reducing calories and increasing exercise (150 minutes of moderate physical activity). The 23 GLB-AIM sessions were delivered through monthly in-person and teleconference calls and participants were encouraged to self-monitor daily caloric/fat intake and physical activity using materials to accurately measure daily calories and exercise, which included a food scale, measuring cups and spoons and a loaned Garmin vívofit® activity tracker and heart rate monitor. Participants shared their logs with lifestyle coaches over the 13 core sessions and lifestyle coaches provided positive reinforcement, feedback, and problem solving techniques as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wait-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>During the initial 6 month intervention period the control group received several contacts from the study staff via mail that included information on general health (e.g., managing stress, getting good sleep), holiday cards, and scheduling reminders for the 3 and 6 month testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>GLB Adapted for Individuals with Impaired Mobility</intervention_name>
    <description>The 12-month Group Lifestyle Balance program, Adapted for individuals with Impaired Mobility (GLB-AIM) promotes 5% - 7% weight loss by reducing calories and increasing energy expenditure to 150 minutes of weekly activity. The 23 GLB-AIM sessions were delivered through monthly in-person and teleconference calls. Participants were encouraged to self-monitor daily caloric/fat intake and physical activity using materials to accurately measure daily calories and exercise, which included a food scale, measuring cups and spoons and a loaned Garmin vívofit® activity tracker and heart rate monitor. Participants shared their logs with lifestyle coaches over the 13 core sessions and lifestyle coaches provided positive reinforcement, feedback, and problem solving techniques as needed.</description>
    <arm_group_label>GLB-AIM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being over 18 years old,&#xD;
&#xD;
          -  having a permanent mobility impairment for at least 1 year,&#xD;
&#xD;
          -  being overweight as evidenced by BMI &gt; 25 or the equivalent value recommended for&#xD;
             spinal cord injury and amputee populations,&#xD;
&#xD;
          -  having sufficient upper arm mobility to engage in exercise, having access to a&#xD;
             telephone, and&#xD;
&#xD;
          -  obtaining physician signed clearance to participate in the weight management&#xD;
             intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  disabilities for which cognitive impairment substantially impairs autonomy (e.g.&#xD;
             mental retardation), as determined by a 5-item everyday autonomy scale,&#xD;
&#xD;
          -  medical issues for which exercise is contraindicated such as uncontrolled hypertension&#xD;
             or coronary heart disease,&#xD;
&#xD;
          -  age 75 or older,&#xD;
&#xD;
          -  pregnancy, and&#xD;
&#xD;
          -  not fluent in English language.&#xD;
&#xD;
        The upper age cut off is intended to ensure that the sample consists of a population whose&#xD;
        permanent mobility impairment is unrelated to aging. Pregnancy is excluded because it is&#xD;
        directly related to weight gain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine Froehlich Grobe, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor Institute for Rehabilitation</affiliation>
  </overall_official>
  <results_reference>
    <citation>Betts AC, Froehlich-Grobe K. Accessible weight loss: Adapting a lifestyle intervention for adults with impaired mobility. Disabil Health J. 2017 Jan;10(1):139-144. doi: 10.1016/j.dhjo.2016.06.004. Epub 2016 Jun 21.</citation>
    <PMID>27431768</PMID>
  </results_reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mobility Limitation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 29, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03307187/Prot_SAP_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/NCT03307187
org study id: 015-049
nct id: NCT03307187
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study tested the effectiveness of the Group Lifestyle Balance™ (GLB) program adapted
      specifically for people with impaired mobility using standard behavioral approaches for
      weight loss. The overarching aim of this study was to promote health and reduce chronic
      disease risk among people with mobility impairment by building an evidence base for weight
      loss. The central hypothesis was that participants randomized to the intervention arm of the
      adapted GLB would show significant improvements on primary outcomes of weight and PA compared
      to a 6-month wait-list control group at 3 and 6 months, and show improvements on several
      secondary health outcomes.
The following are the specific study aims and hypotheses:

      Aim 1: To create an appropriate and usable adaptation of the GLB program for people with
      mobility impairment.

      Hypothesis 1.1: Advisory board participants will identify key adaptations to make the GLB
      materials appropriate and usable for individuals with impaired mobility.

      Aim 2: To establish whether the adapted GLB program for people with mobility impairment is a
      feasible intervention.

      Hypothesis 2.1: Intervention participants will rate the program satisfactorily and attend at
      least 2/3rd of the weekly group-based meetings and monthly individualized phone calls.
      Lifestyle coaches will also rate the adapted program satisfactorily.

      Aim 3: To determine if the GLB intervention adapted for those with mobility impairment is
      effective as determined by significant improvement in the primary and secondary outcomes in
      the intervention group compared to the wait-list control group at 3 and 6 months from
      baseline.

      Hypothesis 3.1: The intervention group will demonstrate significantly greater improvements in
      our primary outcomes (weight and PA) than the wait list control group at 3 and at 6 months
      and will show significant improvements in secondary outcomes at 6 months. Hypothesis 3.2:
      Both groups combined will demonstrate significantly greater improvements in the primary
      outcomes (weight and PA) after 3, 6 and 12 months of intervention and secondary outcomes
      after 6 and 12 months of intervention.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: weight change
time frame: 12 months
description: change in weight collected on 4 times over the year. Weight was measured using a Seca accessible scale (#676); wheelchair users were weighed in their chair on the scale, then transferred to a PT mat table from their chair scale to have their chair weighted separately and body weight was calculated as wheelchair weight subtracted from total weight.
measure: Session Attendance
time frame: 12 months
description: Session attendance recorded for each of the 23 sessions and reported as average attendance at each session
measure: self-monitoring
time frame: over 13 core weeks
description: self-monitoring adherence for daily food intake
measure: physical activity
time frame: baseline, 3, 6, and 12 months
description: self reported physical activity reported on the brief International Physical Activity Questionaire as minutes per week spent in moderate-intensity activity, vigorous-intensity activity, moderate and vigorous activity combined, and minutes per week walking/wheeling
measure: waist circumference
time frame: baseline, 6, and 12 months
description: waist circumference measured while participants laid supine on a PT mat table at the level of the umbilicus, using a fabric measuring tape.
measure: hemoglobin A1c
time frame: baseline, 6, and 12 months
description: hemoglobin A1c was collected by blood draw and sent to the lab for analysis
measure: blood pressure
time frame: baseline, 6, and 12 months
description: resting blood pressure after sitting quietly for 10 minutes using an Omron 3 Series wrist worm blood pressure cuff
measure: cholesterol
time frame: baseline, 3, 6, and 12 months
description: total cholesterol was collected by blood draw during the non-fasting state and sent to the lab for analysis
measure: self-efficacy
time frame: baseline, 3, 6, and 12 months
description: self-efficacy for health promoting behaviors: 27-items of the Self-Rated Abilities for Health Practices scale which assesses participants perceived ability to engage in health promoting activities across 4 domains (Nutrition, Exercise, Health Practices, Psychological Well Being, plus a total self-efficacy score)
arm group label: GLB-AIM
arm group type: Experimental
description: GLB-AIM (Group Lifestyle Balance program, Adapted for individuals with Impaired Mobility) is a 12-month intervention that promotes 5% weight loss by reducing calories and increasing exercise (150 minutes of moderate physical activity). The 23 GLB-AIM sessions were delivered through monthly in-person and teleconference calls and participants were encouraged to self-monitor daily caloric/fat intake and physical activity using materials to accurately measure daily calories and exercise, which included a food scale, measuring cups and spoons and a loaned Garmin vívofit® activity tracker and heart rate monitor. Participants shared their logs with lifestyle coaches over the 13 core sessions and lifestyle coaches provided positive reinforcement, feedback, and problem solving techniques as needed.
arm group label: wait-list control
arm group type: No Intervention
description: During the initial 6 month intervention period the control group received several contacts from the study staff via mail that included information on general health (e.g., managing stress, getting good sleep), holiday cards, and scheduling reminders for the 3 and 6 month testing.
intervention type: Behavioral
intervention name: GLB Adapted for Individuals with Impaired Mobility
description: The 12-month Group Lifestyle Balance program, Adapted for individuals with Impaired Mobility (GLB-AIM) promotes 5% - 7% weight loss by reducing calories and increasing energy expenditure to 150 minutes of weekly activity. The 23 GLB-AIM sessions were delivered through monthly in-person and teleconference calls. Participants were encouraged to self-monitor daily caloric/fat intake and physical activity using materials to accurately measure daily calories and exercise, which included a food scale, measuring cups and spoons and a loaned Garmin vívofit® activity tracker and heart rate monitor. Participants shared their logs with lifestyle coaches over the 13 core sessions and lifestyle coaches provided positive reinforcement, feedback, and problem solving techniques as needed.
arm group label: GLB-AIM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 74 Years
healthy volunteers: No
last name: Katherine Froehlich Grobe, PhD
role: Principal Investigator
affiliation: Baylor Institute for Rehabilitation
citation: Betts AC, Froehlich-Grobe K. Accessible weight loss: Adapting a lifestyle intervention for adults with impaired mobility. Disabil Health J. 2017 Jan;10(1):139-144. doi: 10.1016/j.dhjo.2016.06.004. Epub 2016 Jun 21.
PMID: 27431768
responsible party type: Sponsor
mesh term: Mobility Limitation
sharing ipd: Undecided
provided document: 