Mobility Limitation Clinical Trial
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 Balanceā¢ (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.
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