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临床试验/NCT02921425
NCT02921425已完成不适用

Use of the Track Health Function of the MyHealtheVet Personal Health Record

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2014年7月1日最近更新:
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
47
试验地点
2
主要终点
Body Mass Index

研究概览

简要总结

This study was a pilot 3-month clinical trial that investigated the feasibility, effectiveness, and acceptability of using the Track Health function of the Veterans Health Administration's patient health record for effecting a more positive physical activity (PA) and dietary intake lifestyle in a sample of 38 overweight and obese Veterans with prediabetes. Baseline and three-month post-intervention outcomes were measured in two main domains: objective (e.g., weight) and subjective (e.g., self-efficacy).

详细描述

This was a pilot clinical trial that used a single-group design to test the feasibility, effectiveness, and acceptability of using the Track Health (TH) function of My HealtheVet, the VA's patient health record (PHR), as a tool for effecting a more positive physical activity (PA) and dietary intake lifestyle in overweight and obese Veterans with prediabetes. Baseline and three-month post-intervention outcomes were measured in two main domains: objective (PA as measured by an accelerometer, diet, weight, abdominal circumference, BMI, and blood pressure) and subjective (self-efficacy, intent to adhere to lifestyle change, and patient activation). Assessments, including screening on inclusion and exclusion criteria, physiological measurements, administration of questionnaires, and training on use of two critical features of the TH function--the use of Journals to enter dietary and PA data and the use of Vitals + Readings to enter weight and track physiological measures--took place place across four visits to the study site, which was the Veterans Administration Medical Center in Miami. The investigators hypothesized that this PHR-based intervention would demonstrate improvements and increases, respectively in the objective and subjective domain measures. The investigators also hypothesized that engagement by study participants with MHV would be demonstrated through meeting target criteria regarding making entries into this PHR's TH function, and that participants would be satisfied with the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Veterans with diagnosis of prediabetes (HbA1c 5.7-6.4%, fasting plasma glucose 100-125 mg/dL or oral glucose tolerance test 140-199 mg/dL)
  • English speaking
  • Access to the Internet
  • Body mass index (BMI) of 25-42 kg/m and a sedentary lifestyle (not being physically active three days per week for 20 minutes each time for the previous six months and not performing regular resistance exercise)
  • Able to engage in a regular program of mild-to-moderate intensity physical activity but were not currently following a weight loss diet or participating in an intervention trial

排除标准

  • Cognitively impaired (Mini-Cog greater than or equal to 3)
  • Depressed (PHQ-2 less than or equal to 3)
  • Vision or hearing disorders
  • Have been diagnosed with diabetes mellitus, uncontrolled hypertension, or cardiovascular disease
  • Currently pregnant or nursing.

研究组 & 干预措施

patient health record

Experimental

The study intervention involved the provision to study participants of targeted instruction and practice on use of the Track Health function of the VA's patient health record known as My HealthyVet.

干预措施: patient health record (Behavioral)

结局指标

主要结局

Body Mass Index

时间窗: baseline, 3 months

Measured in kg/m\^2

Systolic and Diastolic Blood Pressure

时间窗: baseline, 3 months

Change From Baseline Energy Expenditure

时间窗: baseline, 3 months

measured in kcal using an accelerometer

Change From Baseline Dietary Intake

时间窗: baseline, 3 months

24-hour dietary recall; the Nutrition Data System for Research used to compute kcal

Change From Baseline Weight

时间窗: Baseline, 3 months

measured in lbs.

Change From Baseline Abdominal Circumference

时间窗: baseline, 3 months

measured in inches

次要结局

  • Change in Intent to Perform Physical Activity(baseline, 3 months)
  • Change in Intent to Adhere to Diet(baseline, 3 months)
  • Change From Baseline Physical Activity Self-efficacy(baseline, 3 months)
  • Change From Baseline Diet Self-efficacy(baseline, 3 months)
  • Change in Patient Activation(baseline, 3 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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