A Multi-Component Behavioral Nutrition Intervention for Homebound Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Caloric Intake
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and feasibility of a multi-level self-management intervention to improve nutritional intake in a group of homebound older adults (HOAs) who are at especially high risk for undernutrition. The study will be guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory and will use a prospective randomized controlled design to estimate whether individually tailored counseling focusing on social and behavioral aspects of eating results in increased caloric intake and improved nutrition-related health outcomes in a sample of 104 HOAs. The investigators hypothesize that intervention at these levels will improve caloric intake and indirectly improve health outcomes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 65 years of age
- •homebound (based upon Medicare's definition of homebound status)
- •able to communicate or have a caregiver who is able to communicate
- •living in a private residence
- •experiencing either an acute illness or chronic condition
- •not consuming enough calories to maintain body weight or weight loss of > 5% over past 6 months (if known)
排除标准
- •significantly cognitive impaired (MMSE < 24 if living alone or MMSE < 15 if living with caregiver) (if known)
- •terminally ill
- •any cancer diagnosis within the past five years (melanoma excluded)
- •end-stage renal disease
- •gastric or enteral tube-feedings
- •dependent on a ventilator
结局指标
主要结局
Caloric Intake
时间窗: 2 and 8 months post-baseline
At each of the data collection points, (3) 24 hour Food Recalls will be collected and measured against each other. Participants who receive the intervention are hypothesized to increase their caloric intake post-baseline.
次要结局
- Health services utilization, specifically hospitalization and re-hospitalization(6 months from follow-up assessment)
研究者
Julie Locher, PhD
Principal Investigator
University of Alabama at Birmingham