Group Lifestyle Balance Adapted for Individuals With Impaired Mobility (GLB-AIM)
NCT ID: NCT03307187
Last Updated: 2017-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
67 participants
INTERVENTIONAL
2015-05-31
2017-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
GLB Adapted for Individuals with Impaired Mobility
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.
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.
No interventions assigned to this group
Interventions
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GLB Adapted for Individuals with Impaired Mobility
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
74 Years
No
Sponsors
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Centers for Disease Control and Prevention
FED
Baylor Research Institute
OTHER
Responsible Party
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Principal Investigators
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Katherine Froehlich Grobe, PhD
Role: PRINCIPAL_INVESTIGATOR
Baylor Institute for Rehabilitation
References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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015-049
Identifier Type: -
Identifier Source: org_study_id