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

Mobility Limitation Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307187
• Other study ID #: 015-049
• Status: Completed
• Phase: N/A
• First received: September 29, 2017
• Last updated: October 10, 2017
• Start date: May 2015
• Est. completion date: February 2017

Study information

• Verified date: October 2017
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mobility Limitation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Centers for Disease Control and Prevention

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight change	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	Session Attendance	Session attendance recorded for each of the 23 sessions and reported as average attendance at each session	12 months
Secondary	self-monitoring	self-monitoring adherence for daily food intake	over 13 core weeks
Secondary	physical activity	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
Secondary	waist circumference	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
Secondary	hemoglobin A1c	hemoglobin A1c was collected by blood draw and sent to the lab for analysis	baseline, 6, and 12 months
Secondary	blood pressure	resting blood pressure after sitting quietly for 10 minutes using an Omron 3 Series wrist worm blood pressure cuff	baseline, 6, and 12 months
Secondary	cholesterol	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
Secondary	self-efficacy	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