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

Kidney Transplant Clinical Trial

— TASK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05151445
• Other study ID #: 2020B0261
• Status: Active, not recruiting
• Start date: March 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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].

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant
• Kidney Transplant; Complications

Intervention

Behavioral:
• mHealth dietary app + health coaching intervention
The "Lose-It" app will be set up with Gmail accounts with unique unidentifiable codes developed by the research team. Participants be trained to enter their dietary intake and physical activity daily for 12-weeks. Participants will monitor their vegetable intake, fat intake, carbohydrate intake, weight, and blood pressure. Wi-Fi connected weight scales and blood pressure cuff will be supplied for weight and blood pressure monitoring. Participants will be taught how to sync the data from the scales and blood pressure cuff to the app for the research team to access. Participants will perform a return demonstration to confirm that they can record their dietary intake daily, physical activity, weight, and blood pressure using the "Lose-It" app. We also review with the participant the "My Plate" method for proper nutrition and the steps to distance conversion chart.

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Feasibility of the study Recruitment for the Study	Recruitment (percent of participants approached to be in the study), will be recorded by the research assistant.	Baseline
Primary	The Feasibility of Participant Retention for the Study	Retention (percent of participants that dropped during the study), will be recorded by the research assistant.	To assess for a change in participant retention from Baseline, 4 weeks, 8 weeks, and 12 weeks
Primary	The Feasibility of Adherence for using the Lose- It App to Record Diet and Physical Actvity	Adherence (percent to adhere to logging daily dietary intake and physical activity) will be recorded continuously each day by the "Lose-It" app.	To assess for a change in participant adherence from Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary	Perceived Stress Level	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. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.	To assess for a change in participant perceived stress from Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary	Exercise Self-Efficacy	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."	To assess for a change in participant exercise self-efficacy from Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary	Fruit and Vegetable Intake	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.	To assess for a change in participant fruit, vegetable, and fiber intake from Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary	Fiber Intake	Fiber 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.	To assess for a change in participant fruit, vegetable, and fiber intake from Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary	Fat Intake	The participant will record their percent of fat intake each day into the Lose-it Premium application.	To assess for a change in participant fat intake from Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary	Carbohydrate Intake	The participant will record their percent of carbohydrate intake each day into the Lose-it Premium application.	To assess for a change in participant carbohydrate intake from Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary	Weight	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.	To assess for a change in participant weight from Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary	Systolic Blood Pressure	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.	To assess for a change in participant systolic blood pressure from Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary	Diastolic Blood Pressure	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.	To assess for a change in participant diastolic blood pressure from Baseline, 4 weeks, 8 weeks, and 12 weeks

External Links

•   National Institute of Diabetes and Digestive and Kidney Diseases. Mission & Vision. 2019 Accessed August, 30, 2019
•   National Institute of Nursing Research. The NINR Strategic Plan: Advancing Science, Improving Lives 2016 Accessed May, 28, 2019.