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Group Lifestyle Balance Adapted for Individuals With Impaired Mobility (GLB-AIM) (GLB-AIM)

Primary Purpose

Mobility Limitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GLB Adapted for Individuals with Impaired Mobility
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mobility Limitation

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • being over 18 years old,
  • having a permanent mobility impairment for at least 1 year,
  • being overweight as evidenced by BMI > 25 or the equivalent value recommended for spinal cord injury and amputee populations,
  • having sufficient upper arm mobility to engage in exercise, having access to a telephone, and
  • obtaining physician signed clearance to participate in the weight management intervention.

Exclusion Criteria:

  • disabilities for which cognitive impairment substantially impairs autonomy (e.g. mental retardation), as determined by a 5-item everyday autonomy scale,
  • medical issues for which exercise is contraindicated such as uncontrolled hypertension or coronary heart disease,
  • age 75 or older,
  • pregnancy, and
  • not fluent in English language.

The upper age cut off is intended to ensure that the sample consists of a population whose permanent mobility impairment is unrelated to aging. Pregnancy is excluded because it is directly related to weight gain.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    GLB-AIM

    wait-list control

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    weight change
    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.

    Secondary Outcome Measures

    Session Attendance
    Session attendance recorded for each of the 23 sessions and reported as average attendance at each session
    self-monitoring
    self-monitoring adherence for daily food intake
    physical activity
    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
    waist circumference
    waist circumference measured while participants laid supine on a PT mat table at the level of the umbilicus, using a fabric measuring tape.
    hemoglobin A1c
    hemoglobin A1c was collected by blood draw and sent to the lab for analysis
    blood pressure
    resting blood pressure after sitting quietly for 10 minutes using an Omron 3 Series wrist worm blood pressure cuff
    cholesterol
    total cholesterol was collected by blood draw during the non-fasting state and sent to the lab for analysis
    self-efficacy
    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)

    Full Information

    First Posted
    September 29, 2017
    Last Updated
    October 10, 2017
    Sponsor
    Baylor Research Institute
    Collaborators
    Centers for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03307187
    Brief Title
    Group Lifestyle Balance Adapted for Individuals With Impaired Mobility (GLB-AIM)
    Acronym
    GLB-AIM
    Official Title
    Group Lifestyle Balance Adapted for Impaired Mobility (GLB-AIM): Translating the GLB to Promote Healthy Weight in People With Mobility Disability (Impairment)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (Actual)
    Primary Completion Date
    February 2017 (Actual)
    Study Completion Date
    February 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Baylor Research Institute
    Collaborators
    Centers for Disease Control and Prevention

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mobility Limitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GLB-AIM
    Arm Type
    Experimental
    Arm 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 Title
    wait-list control
    Arm Type
    No Intervention
    Arm 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(s)
    GLB Adapted for Individuals with Impaired Mobility
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    weight change
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Session Attendance
    Description
    Session attendance recorded for each of the 23 sessions and reported as average attendance at each session
    Time Frame
    12 months
    Title
    self-monitoring
    Description
    self-monitoring adherence for daily food intake
    Time Frame
    over 13 core weeks
    Title
    physical activity
    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
    Time Frame
    baseline, 3, 6, and 12 months
    Title
    waist circumference
    Description
    waist circumference measured while participants laid supine on a PT mat table at the level of the umbilicus, using a fabric measuring tape.
    Time Frame
    baseline, 6, and 12 months
    Title
    hemoglobin A1c
    Description
    hemoglobin A1c was collected by blood draw and sent to the lab for analysis
    Time Frame
    baseline, 6, and 12 months
    Title
    blood pressure
    Description
    resting blood pressure after sitting quietly for 10 minutes using an Omron 3 Series wrist worm blood pressure cuff
    Time Frame
    baseline, 6, and 12 months
    Title
    cholesterol
    Description
    total cholesterol was collected by blood draw during the non-fasting state and sent to the lab for analysis
    Time Frame
    baseline, 3, 6, and 12 months
    Title
    self-efficacy
    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)
    Time Frame
    baseline, 3, 6, and 12 months

    10. Eligibility

    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: being over 18 years old, having a permanent mobility impairment for at least 1 year, being overweight as evidenced by BMI > 25 or the equivalent value recommended for spinal cord injury and amputee populations, having sufficient upper arm mobility to engage in exercise, having access to a telephone, and obtaining physician signed clearance to participate in the weight management intervention. Exclusion Criteria: disabilities for which cognitive impairment substantially impairs autonomy (e.g. mental retardation), as determined by a 5-item everyday autonomy scale, medical issues for which exercise is contraindicated such as uncontrolled hypertension or coronary heart disease, age 75 or older, pregnancy, and not fluent in English language. The upper age cut off is intended to ensure that the sample consists of a population whose permanent mobility impairment is unrelated to aging. Pregnancy is excluded because it is directly related to weight gain.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Katherine Froehlich Grobe, PhD
    Organizational Affiliation
    Baylor Institute for Rehabilitation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27431768
    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.
    Results Reference
    result
    PubMed Identifier
    33160798
    Citation
    Froehlich-Grobe K, Betts AC, Driver SJ, Carlton DN, Lopez AM, Lee J, Kramer MK. Group Lifestyle Balance Adapted for Individuals With Impaired Mobility: Outcomes for 6-Month RCT and Combined Groups at 12 Months. Am J Prev Med. 2020 Dec;59(6):805-817. doi: 10.1016/j.amepre.2020.06.023. Epub 2020 Nov 5.
    Results Reference
    derived

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    Group Lifestyle Balance Adapted for Individuals With Impaired Mobility (GLB-AIM)

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