NCT03307187

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

September 29, 2017

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Session Attendance

    12 months

  • self-monitoring

    over 13 core weeks

  • physical activity

    baseline, 3, 6, and 12 months

  • waist circumference

    baseline, 6, and 12 months

  • hemoglobin A1c

    baseline, 6, and 12 months

  • +3 more secondary outcomes

Study Arms (2)

GLB-AIM

EXPERIMENTAL

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.

Behavioral: GLB Adapted for Individuals with Impaired Mobility

wait-list control

NO INTERVENTION

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.

Interventions

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.

GLB-AIM

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Katherine Froehlich Grobe, PhD

    Baylor Institute for Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2017

First Posted

October 11, 2017

Study Start

May 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 12, 2026

Record last verified: 2026-02