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

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Mobility Limitation

Treatments: Behavioral: GLB Adapted for Individuals with Impaired Mobility

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03307187

015-049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

GLB-AIM

Experimental group

Description:

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.

Treatment:

Behavioral: GLB Adapted for Individuals with Impaired Mobility

wait-list control

No Intervention group

Description:

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.