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Mobility LimitationGLB-AIMNCT03307187

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

A study testing GLB Adapted for Individuals with Impaired Mobility in people with Mobility Limitation, run by Baylor Research Institute.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Mobility Limitation
What is being tested?
GLB Adapted for Individuals with Impaired Mobility
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
No sites listed yet
Study dates
May 2015to Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Group Lifestyle Balance Adapted for Impaired Mobility (GLB-AIM): Translating the GLB to Promote Healthy Weight in People With Mobility Disability (Impairment)

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.

Read the 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.

Being tested
GLB Adapted for Individuals with Impaired Mobility
Medical subject headings
Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLB Adapted for Individuals with Impaired MobilityBehavioural

    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.

Study groups in NCT03307187
Study groupRoleWhat they receive
GLB-AIMExperimentalGLB-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.
Receives: Behavioral: GLB Adapted for Individuals with Impaired Mobility
wait-list controlNo interventionDuring 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (8)

  1. Session Attendance

    Session attendance recorded for each of the 23 sessions and reported as average attendance at each session

    Measured: 12 months

  2. self-monitoring

    self-monitoring adherence for daily food intake

    Measured: over 13 core weeks

  3. 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

    Measured: baseline, 3, 6, and 12 months

  4. 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.

    Measured: baseline, 6, and 12 months

  5. hemoglobin A1c

    hemoglobin A1c was collected by blood draw and sent to the lab for analysis

    Measured: baseline, 6, and 12 months

  6. blood pressure

    resting blood pressure after sitting quietly for 10 minutes using an Omron 3 Series wrist worm blood pressure cuff

    Measured: baseline, 6, and 12 months

  7. cholesterol

    total cholesterol was collected by blood draw during the non-fasting state and sent to the lab for analysis

    Measured: baseline, 3, 6, and 12 months

  8. 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)

    Measured: baseline, 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2017
  2. Study startMay 2015
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03307187
Sponsor's protocol ID
015-049
Acronym
GLB-AIM
Status last verified
Feb 2026
First submitted
29 Sep 2017
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27431768

  • 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.

    PubMed 33160798

Questions about this trial

What is this clinical trial studying?

A study testing GLB Adapted for Individuals with Impaired Mobility in people with Mobility Limitation, run by Baylor Research Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

weight change (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03307187, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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