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

August 12, 2024 updated by: Tara O'Brien, Ohio State University
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].

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The participants will be recruited or contacted from a list of kidney recipients that have already requested they be contacted for future studies from our previous study. This list consists of approximately 60 people.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Feasibility of the Study Recruitment for the Study
Time Frame: Baseline
Recruitment (percent of participants approached to be in the study), will be recorded by the research assistant.
Baseline
The Feasibility of Participant Retention for the Study
Time Frame: 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.
Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Time Frame: Weekly for 12 weeks
Adherence (percent to adhere to logging daily dietary intake) will be recorded continuously each day by the "Lose-It" app.
Weekly for 12 weeks
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Time Frame: Weekly for 12 weeks
Adherence (percent to adhere to logging daily physical activity) will be recorded continuously each day by the "Lose-It" app.
Weekly for 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Level
Time Frame: 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.
Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Exercise Self-Efficacy
Time Frame: 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.
Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Fruit and Vegetable Servings Per Day
Time Frame: 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.
Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Fiber Intake
Time Frame: 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.
Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Fat Intake
Time Frame: 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.
Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Carbohydrate Intake
Time Frame: 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.
Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Weight
Time Frame: 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.
Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Systolic Blood Pressure
Time Frame: 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.
Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Diastolic Blood Pressure
Time Frame: 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.
Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 27, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2020B0261

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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