- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03307187
Group Lifestyle Balance Adapted for Individuals With Impaired Mobility (GLB-AIM) (GLB-AIM)
Group Lifestyle Balance Adapted for Impaired Mobility (GLB-AIM): Translating the GLB to Promote Healthy Weight in People With Mobility Disability (Impairment)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GLB-AIM
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.
|
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.
|
No Intervention: wait-list control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weight change
Time Frame: 12 months
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Session Attendance
Time Frame: 12 months
|
Session attendance recorded for each of the 23 sessions and reported as average attendance at each session
|
12 months
|
self-monitoring
Time Frame: over 13 core weeks
|
self-monitoring adherence for daily food intake
|
over 13 core weeks
|
physical activity
Time Frame: baseline, 3, 6, and 12 months
|
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
|
baseline, 3, 6, and 12 months
|
waist circumference
Time Frame: baseline, 6, and 12 months
|
waist circumference measured while participants laid supine on a PT mat table at the level of the umbilicus, using a fabric measuring tape.
|
baseline, 6, and 12 months
|
hemoglobin A1c
Time Frame: baseline, 6, and 12 months
|
hemoglobin A1c was collected by blood draw and sent to the lab for analysis
|
baseline, 6, and 12 months
|
blood pressure
Time Frame: baseline, 6, and 12 months
|
resting blood pressure after sitting quietly for 10 minutes using an Omron 3 Series wrist worm blood pressure cuff
|
baseline, 6, and 12 months
|
cholesterol
Time Frame: baseline, 3, 6, and 12 months
|
total cholesterol was collected by blood draw during the non-fasting state and sent to the lab for analysis
|
baseline, 3, 6, and 12 months
|
self-efficacy
Time Frame: baseline, 3, 6, and 12 months
|
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)
|
baseline, 3, 6, and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine Froehlich Grobe, PhD, Baylor Institute for Rehabilitation
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 015-049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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