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

Sponsor
Ohio State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05151445
Collaborator
(none)
20
Enrollment
1
Location
27
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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].

Condition or Disease Intervention/Treatment Phase
  • Behavioral: mHealth dietary app + health coaching intervention

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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Use of a Consumer-Based mHealth Dietary App and Health Coaching With Kidney Transplant Recipients
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. The Feasibility of Participant Retention for the Study [To assess for a change in participant retention from 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 and Physical Actvity [To assess for a change in participant adherence from Baseline, 4 weeks, 8 weeks, and 12 weeks]

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

Secondary Outcome Measures

  1. Perceived Stress Level [To assess for a change in participant perceived stress from 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. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.

  2. Exercise Self-Efficacy [To assess for a change in participant exercise self-efficacy from 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."

  3. Fruit and Vegetable Intake [To assess for a change in participant fruit, vegetable, and fiber intake from 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.

  4. Fiber Intake [To assess for a change in participant fruit, vegetable, and fiber intake from 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 assess fruit and vegetable intake using a Likert Scale to rate intake from less than1/ per week to more than 2 a day.

  5. Fat Intake [To assess for a change in participant fat intake from 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 [To assess for a change in participant carbohydrate intake from 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 [To assess for a change in participant weight from 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 [To assess for a change in participant systolic blood pressure from 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 [To assess for a change in participant diastolic blood pressure from 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ohio State University Medical Center Columbus Ohio United States 43210

Sponsors and Collaborators

  • Ohio State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
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
ClinicalTrials.gov Identifier:
NCT05151445
Other Study ID Numbers:
  • 2020B0261
First Posted:
Dec 9, 2021
Last Update Posted:
Dec 9, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 9, 2021