Skip to main content
OpenTrials
Completed

NCT Number: NCT05151445

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

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].

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Transplant Kidney Transplant; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mHealth dietary app + health coaching intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Acronym: TASK

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2021
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.