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临床试验/NCT05151445
NCT05151445已完成不适用

The Use of a Consumer-Based mHealth Dietary App and Health Coaching With Kidney Transplant Recipients

Ohio State University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
The Feasibility of the Study Recruitment for the Study

研究概览

简要总结

The purpose of the study is to test the feasibility mHealth dietary app + health coaching for improving primary outcomes (recruitment, retention, and adherence) and secondary outcomes (perceived stress [ Perceived Stress Scale], exercise self-efficacy[Exercise Self-efficacy Scale], vegetable intake [Fruit, Vegetables, and Fiber Screen] fat intake [Lose-it Premium database], carbohydrate intake [Lose-it Premium database], weight, [Wi-Fi weight scale using the Lose-it Premium database], and blood pressure [Wi-Fi blood pressure cuff using the Lose-it Premium database].

详细描述

The proposed study seeks to shift the paradigm for promoting diet intake and physical activity using education and self-report to provide a powerful combination of mHealth dietary app and health coaching (set goals, provide ongoing feedback, and self-monitor behaviors). To the investigators knowledge, this is the first time a mHealth dietary app and health coaching intervention has been used in kidney transplant recipients to link real-time data for monitoring dietary intake and physical activity.

The long-term goal of this work is to enhance well-being in kidney recipients via lifestyle self-management of care for dietary intake and physical activity to ultimately prevent chronic diseases. The proposed study is important because early weight gain after kidney transplant is associated with adverse effects on the transplanted kidney function resulting in increased health care cost and poor quality of life. Interventions are needed to monitor kidney transplant recipients diet and physical activity in real-time to prevent health decline.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • age 18 or older men and women
  • functioning KTR (not on dialysis)
  • ability to speak, read, and hear English,
  • possession of a smartphone capable of accessing and downloading a mHealth dietary app
  • Wi-Fi or Internet access,
  • greater than 3 months post-transplant (due to medication adjustments and decreased functional levels),
  • not hospitalized
  • capable of self-consent per capacity screening.

排除标准

  • Participation in a weight loss program
  • participation in a structured exercise program
  • diagnosis of dementia.

结局指标

主要结局

The Feasibility of the Study Recruitment for the Study

时间窗: Baseline

Recruitment (percent of participants approached to be in the study), will be recorded by the research assistant.

The Feasibility of Participant Retention for the Study

时间窗: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks

Retention (percent of participants that dropped during the study), will be recorded by the research assistant.

The Feasibility of Adherence for Using the Lose- It App to Record Diet

时间窗: Weekly for 12 weeks

Adherence (percent to adhere to logging daily dietary intake) will be recorded continuously each day by the "Lose-It" app.

The Feasibility of Adherence for Using the Lose- It App to Physical Actvity

时间窗: Weekly for 12 weeks

Adherence (percent to adhere to logging daily physical activity) will be recorded continuously each day by the "Lose-It" app.

次要结局

  • Perceived Stress Level(Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks)
  • Exercise Self-Efficacy(Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks)
  • Fruit and Vegetable Servings Per Day(Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks)
  • Fiber Intake(Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks)
  • Fat Intake(Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks)
  • Carbohydrate Intake(Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks)
  • Weight(Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks)
  • Systolic Blood Pressure(Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks)
  • Diastolic Blood Pressure(Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tara O'Brien

Assistant Professor at Center for Healthy Aging, Self-Management and Complex Care, Distinguished Educator in Gerontological Nursing/National Hartford Centers of Gerontological Nursing Excellence

Ohio State University

研究点 (1)

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