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Completed

NCT Number: NCT03307187

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

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.

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Key information

Conditions

Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GLB Adapted for Individuals with Impaired Mobility

Behavioral

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.

Primary outcomes

  1. weight change

    Time frame: 12 months

    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.

Secondary outcomes

  1. Session Attendance

    Time frame: 12 months

    Session attendance recorded for each of the 23 sessions and reported as average attendance at each session

  2. self-monitoring

    Time frame: over 13 core weeks

    self-monitoring adherence for daily food intake

  3. physical activity

    Time frame: baseline, 3, 6, and 12 months

    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

  4. waist circumference

    Time frame: baseline, 6, and 12 months

    waist circumference measured while participants laid supine on a PT mat table at the level of the umbilicus, using a fabric measuring tape.

  5. hemoglobin A1c

    Time frame: baseline, 6, and 12 months

    hemoglobin A1c was collected by blood draw and sent to the lab for analysis

  6. blood pressure

    Time frame: baseline, 6, and 12 months

    resting blood pressure after sitting quietly for 10 minutes using an Omron 3 Series wrist worm blood pressure cuff

  7. cholesterol

    Time frame: baseline, 3, 6, and 12 months

    total cholesterol was collected by blood draw during the non-fasting state and sent to the lab for analysis

  8. self-efficacy

    Time frame: baseline, 3, 6, and 12 months

    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)

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Group Lifestyle Balance Adapted for Impaired Mobility (GLB-AIM): Translating the GLB to Promote Healthy Weight in People With Mobility Disability (Impairment)

Acronym: GLB-AIM

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 11, 2017
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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