Pilot Clinical Trial for a Mobile Health Intervention to Support Healthful Dietary Choices in Older Person
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change From Baseline HOMA-IR Score at 3 Months
研究概览
简要总结
This will be a pilot clinical trial to evaluate preliminary efficacy of a newly designed mobile intervention designed to support healthy eating in old people. The main scientific premise of this project is that mobile approaches are feasible for behavioral and metabolic improvements in the population of people 65+ with mild-to-moderate frailty. Specific Aim of this project is to describe feasibility, acceptability and initial efficacy of the newly designed mobile intervention in a pilot RCT. The pilot RCT, comparing usual care to usual care plus mobile intervention, will provide data on the sensitivity of outcome measures and estimated effect size to inform a larger RCT. Primary outcomes for the pilot RCT will include change in adherence to Mediterranean diet (MedD) score, change in insulin sensitivity measures, feasibility and acceptability. Secondary outcomes include MedD knowledge, self-efficacy, outcome expectation, self-regulation, social support, platform use and anthropometric and functional measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Mild to moderate frailty
- •Suboptimal diet
排除标准
- •Dependence in activities of daily living
- •Memory Impairment
- •Hearing or visual impairment
- •Unusual dietary restrictions
结局指标
主要结局
Change From Baseline HOMA-IR Score at 3 Months
时间窗: baseline, 3 month
Insulin resistance scores, homeostatic model (HOMA-IR) was calculated with the following formula: fasting plasma glucose (in mmol/L) X fasting plasma insulin (in lU/mL) divided by 22.5. Higher score indicates worse insulin resistance. Typically, a HOMA-IR value of less than 1 is considered normal, indicating low insulin resistance.
Change From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months
时间窗: baseline, 3 month
Alternative MED (aMED) score will be calculated using the Food Frequency Questionnaire (FFQ). aMED scores range from 0 (nonadherence) to 9 (perfect adherence)
次要结局
- Change From Baseline Negative Outcome Expectations Score at 3 Months(baseline, 3 month)
- Change From Baseline Positive Outcome Expectations Score at 3 Months(baseline, 3 month)
- Change From Baseline Self-Efficacy Score at 3 Months(baseline, 3 month)
- Change From Baseline Social Support Score at 3 Months(baseline, 3 month)
- Change From Baseline Mediterranean Diet Knowledge Score at 3 Months(baseline, 3 month)
- Change From Baseline Physical Performance Measure at 3 Months(baseline, 3 month)
- Change From Baseline BMI at 3 Months(baseline, 3 month)
- Change From Baseline Self-regulation Score at 3 Months(baseline, 3 month)
研究者
Oleg Zaslavsky
Associate Professor: Biobehavioral Nursing & Health Informatics
University of Washington