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

Completed

Conditions: Kidney Transplant; Complications
Kidney Transplant

Interventions: Behavioral: mHealth dietary app + health coaching intervention

Registration Number: NCT05151445

Lead Sponsor: Ohio State University

Brief Summary: 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 \[Wi-Fi blood pressure cuff using the Lose-it Premium database\].

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mHealth dietary app + health coaching intervention	mHealth dietary app + health coaching intervention	A feasibility study will be utilized to establish the recruitment, retention, and adherence with post-kidney transplant recipients using a consumer-based mHealth dietary app + health coaching.

Primary Outcome Measures

Name	Time	Method
The Feasibility of the Study Recruitment for the Study	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	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	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	Weekly for 12 weeks	Adherence (percent to adhere to logging daily physical activity) will be recorded continuously each day by the "Lose-It" app.

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Level	Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks	Perceived Stress Scale will be evaluated by using the Perceived Stress Scale (PSS).The PSS is a 10-item questionnaire using a Likert Scale to rate feelings of stress from 0 "never" to 4 "very often." Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Exercise Self-Efficacy	Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks	Exercise Self-Efficacy Scale will be evaluated by using the Self-Efficacy for Exercise (SEE) Scale. The SEE is a 9-item questionnaire using a Likert Scale to rate feelings of stress from 0 "not confident" to 10 "very confident." This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Fruit and Vegetable Servings Per Day	Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks	Fruit and vegetable intake will be assessed using the Fruit, Vegetable and Fiber Screen which uses a scale to assess fruit and vegetable intake using a Likert Scale to rate intake from less than1/ per week to more than 2 a day. Higher scores indicate that more fruits and vegetables are being consumed by participants.
Fiber Intake	Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks	Fiber intake will be assessed using the Fruit, Vegetable and Fiber Screen which uses a scale to assessfiber intake using a Likert Scale to rate intake from less than1/ per week to more than 2 a day.Higher scores indicate more fiber intake.
Fat Intake	Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks	The participant will record their percent of fat intake each day into the Lose-it Premium application.
Carbohydrate Intake	Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks	The participant will record their percent of carbohydrate intake each day into the Lose-it Premium application.
Weight	Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks	Weight (pounds) will be measured each day by the participant using a wireless Wi Fi weight scale. The data from the wireless weight scale will sync the data from the participant's mobile phone to the premium password-protect "Lose-It" database each day.
Systolic Blood Pressure	Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks	Systolic blood pressure (millimeters of mercury \[mmHg\]) will be recorded each day by the participant using a wireless Wi Fi blood pressure cuff. The data from the wireless cuff will sync from the participant's mobile phone to the premium password-protect "Lose-It" database each day.
Diastolic Blood Pressure	Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks	Systolic blood pressure (millimeters of mercury \[mmHg\]) will be recorded each day by the participant using a wireless Wi Fi blood pressure cuff. The data from the wireless cuff will sync from the participant's mobile phone to the premium password-protect "Lose-It" database each day.