NCT02223728已完成不适用
Evaluation of Telehealth Lifestyle Program for Persons With Traumatic Brain Injury: Objective 2
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Body Mass Index (BMI) scores
研究概览
简要总结
Interventions to help individuals with traumatic brain injury manage their healthy lifestyle behaviors have been limited. Thus, the goal of this project is to evaluate the efficacy of a telehealth lifestyle program on reductions in weight and improvements in health behaviors/lifestyle choices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 19 years or older
- •English speaking
- •sustained a moderate or severe TBI (as defined by a period of confusion after the injury of more than 24 hours)
- •overweight or obese as defined by a BMI score of ≥ 25 kg/m2
- •1-year or greater post-injury
- •not currently enrolled in a weight loss program or receiving weight loss medication
- •regular access to a computer/laptop with internet capability which allows internet and telephone access simultaneously
- •if person with TBI who meets criteria 1-7 but does not cook, shop, and/or prepare meals independently, he or she must have a non-paid, study partner willing to participate in the study.
排除标准
- •pregnant or planning to become pregnant in the next 7 months
- •concurrent medical condition for which changes in exercise or diet would be contraindicated
- •severe hearing or visual impairment
- •significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded)
- •unable to communicate
- •significant cognitive impairment and without a study partner, and/or
- •person with TBI who does not cook, shop, and/or prepare meals independently who does not have a non-paid, study partner willing to participate in the study
- •currently enrolled in an organized weight loss program
- •has lost > 10% of body weight over the past 6 months
- •history of an eating disorder
研究组 & 干预措施
Treatment Condition
Experimental
Telehealth Lifestyle Program
干预措施: Lifestyle (Behavioral)
Attention Control Condition
Sham Comparator
Health Education Program
干预措施: Health Education (Behavioral)
结局指标
主要结局
Body Mass Index (BMI) scores
时间窗: Changes in baseline and post-program BMI scores at 7-months
次要结局
未报告次要终点
研究者
Laura E. Dreer, PhD
Assistant Professor
University of Alabama at Birmingham
研究点 (2)
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