Group Lifestyle Balance Adapted for Impaired Mobility (GLB-AIM): Translating the GLB to Promote Healthy Weight in People With Mobility Disability (Impairment)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 主要终点
- weight change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
GLB-AIM
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.
干预措施: GLB Adapted for Individuals with Impaired Mobility (Behavioral)
wait-list control
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.
结局指标
主要结局
weight change
时间窗: 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.
次要结局
- Session Attendance(12 months)
- self-efficacy(baseline, 3, 6, and 12 months)
- hemoglobin A1c(baseline, 6, and 12 months)
- blood pressure(baseline, 6, and 12 months)
- self-monitoring(over 13 core weeks)
- physical activity(baseline, 3, 6, and 12 months)
- waist circumference(baseline, 6, and 12 months)
- cholesterol(baseline, 3, 6, and 12 months)