Clinical trial NCT03307187: Group Lifestyle Balance Adapted for Individuals With Impaired Mobility (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
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2017-10-11
Enrollment: 67
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: weight change
timeFrame: 12 months
Secondary outcomes:
measure: Session Attendance
timeFrame: 12 months
measure: self-monitoring
timeFrame: over 13 core weeks
measure: physical activity
timeFrame: baseline, 3, 6, and 12 months
measure: waist circumference
timeFrame: baseline, 6, and 12 months
measure: hemoglobin A1c
timeFrame: baseline, 6, and 12 months
measure: blood pressure
timeFrame: baseline, 6, and 12 months
measure: cholesterol
timeFrame: baseline, 3, 6, and 12 months
measure: self-efficacy
timeFrame: baseline, 3, 6, and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Baylor Institute for Rehabilitation
name: Katherine Froehlich Grobe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.