Daily Self-weighing Feedback for Wheelchair Users to Promote Weight Loss Through Use of the E-scale
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Weight Change
研究概览
简要总结
The goals of the proposed study are to test the usability, feasibility and preliminary efficacy of the E-Scale with wheelchair users. The E-scale was developed as a weight monitoring technology for wheelchair users. Up to fifteen overweight or obese wheelchair users will be enrolled in a 13 week study that includes standard behavioral treatment (SBT) for weight loss, which focuses on diet, physical activity, and behavioral strategies (e.g., goal setting, self-monitoring) to support lifestyle changes specifically for people with mobility impairments. The subjects will also be provided the E-scale to track their weight daily. The outcome measure include usefulness (subjective feedback from a survey about the program/E-scale), feasibility (accuracy and repeatable measurements from the E-scale) and efficacy (improvements in weight and other measures of health) of the weight loss program coupled with the E-scale at the end of 13 weeks. The primary hypothesis is that the E-scale coupled with the weight loss intervention will result in significant improvements in weight, abdominal girth, body fat percentage, and the Center for Epidemiologic Studies Depression Scale (CES-D).The results may inform the refinement of this technology to increase its applicability for wheelchair users to independently monitor their weight in their own homes while attempting to lose weight.
详细描述
Wheelchair users have about twice the prevalence of obesity than the general population. There is also very little or no technology to which they have access to measure their weight frequently in their homes. Research however, has shown that monitoring your body weight frequently (i.e. daily) yields significantly better weight loss and weight maintenance results. This research has never included wheelchair users because they have not had access to technology to be able to measure their weight daily. The E-scale was developed as a weight monitoring technology for wheelchair users and has been tested for precision and accuracy in the laboratory. The goal of this study is to determine the usefulness, feasibility and efficacy of the E-scale system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users.
Up to fifteen overweight or obese wheelchair users will be enrolled in a 13 week study that includes standard behavioral treatment (SBT) for weight loss, which focuses on diet, physical activity, and behavioral strategies (e.g., goal setting, self-monitoring) to support lifestyle changes specifically for people with mobility impairments. The subjects will also be provided the E-scale to track their weight daily. The outcome measure include usefulness (subjective feedback from a survey about the program/E-scale), feasibility (accuracy and repeatable measurements from the E-scale) and efficacy (improvements in weight and other measures of health) of the weight loss program coupled with the E-scale at the end of 13 weeks.
Study hypotheses are:
Hypothesis 1: The E-scale will be useful based on self-reported feedback from wheelchair users by more than 50% stating that the E-scale is easy to use, their preferred weight monitoring system, them feeling that they would use the E-scale if it was available for them to purchase.
Hypothesis 2: The E-scale will be feasible by providing accurate (+/- 2 lbs. from a calibrated scale measurement) and repeatable (<3lbs difference from day-to-day) weight measurements and by the wheelchair users continuing to use the scale more than 70% of the days of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Use Wheelchair as primary means of mobility
- •Uses a bed with 4 legs
- •Body mass index (BMI) ≥27 and ≤40.0
- •Has daily access to Internet
- •Currently owns or willing to use an android device
- •Provides physician clearance to participate in a weight loss intervention
- •Speaks English
排除标准
- •Presence of an unstable condition requiring physician-supervised diet and exercise (e.g., diabetes, recent myocardial infarction)
- •Presence of condition precluding engagement in exercise at moderate intensity (e.g., asthma, congestive heart failure, etc.)
- •Pregnancy or intention to become pregnant during study
- •Currently being treated for any psychological issues or problems, taking any psychotropic medications, or receiving treatment with psychotropic medications within the previous 6 months
- •Reported alcohol intake > 4 drinks/day
- •Reported participation in a formal weight loss program, loss of ≥5% weight in the past 6 months, or current use of weight loss medication.
- •History of bariatric surgery (lap-band, gastric bypass, etc.)
- •Planned extended vacations, absences, or relocation during study
- •A score ≥20 on the Center for Epidemiologic Studies Depression Scale (CES-D)
- •A classification of Anorexia Nervosa, Bulimia Nervosa or Binge Eating Disorder on the Eating Disorder Diagnosis Scale (EDDS)
研究组 & 干预措施
E-Scale
E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users
干预措施: E-Scale (Device)
结局指标
主要结局
Weight Change
时间窗: baseline and 13 weeks
Change in body weight
次要结局
- Abdominal Girth Change(baseline and 13 weeks)
- Body-fat Percentage Change(13 weeks)
- Depression Score at Baseline(Baseline only)
研究者
Jonathan Pearlman
Associate Professor
University of Pittsburgh