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NCT05151445: TASK

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

Completed Results posted Last updated 28 October 2024
What this trial tests

trial testing mHealth dietary app + health coaching intervention in Kidney Transplant in 20 participants. Completed in 31 December 2023.

Timeline
1 March 2021
Primary endpoint
1 January 2023
31 December 2023

Quick facts

Lead sponsorOhio State University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment20
Start date1 March 2021
Primary completion1 January 2023
Estimated completion31 December 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Ohio State University

Who can join

18 and older, any sex, with Kidney Transplant or Kidney Transplant; Complications. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Feasibility of the Study Recruitment for the Study Primary · Baseline

Recruitment (percent of participants approached to be in the study), will be recorded by the research assistant.

GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention20
The Feasibility of Participant Retention for the Study Primary · 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.

Baseline
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention20
4 weeks
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention18
8 weeks
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention18
12 weeks
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention17
The Feasibility of Adherence for Using the Lose- It App to Record Diet Primary · Weekly for 12 weeks

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

Week 1
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention17
Week 2
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention17
Week 3
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention17
Week 4
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention16
Week 5
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention16
Week 6
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention16
Week 7
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention15
Week 8
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention16
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity Primary · Weekly for 12 weeks

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

Week 1
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention5
Week 2
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention5
Week 3
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention6
Week 4
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention5
Week 5
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention3
Week 6
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention3
Week 7
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention5
Week 8
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention4
Perceived Stress Level Secondary · 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.

Baseline
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention21.65± 3.88
Week 4
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention17.56± 5.03
Week 8
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention18.00± 4.79
Week 12
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention18.82± 5.27
Exercise Self-Efficacy Secondary · 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.

Baseline
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention60.75± 23.35
Week 4
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention71.00± 18.69
Week 8
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention71.17± 17.67
Week 12
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention80.71± 17.68
Fruit and Vegetable Servings Per Day Secondary · 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.

Baseline - 2 Servings or Less
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention11
Basline - 3 Servings or More
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention8
Week 4 - 2 Servings or Less
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention8
Week 4 - 3 Servings or More
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention10
Week 8 - 2 Servings or Less
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention9
Week 8 - 3 Servings or More
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention9
Week 12 - 2 Servings or Less
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention7
Week 12 - 3 Servings or More
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention10
Fiber Intake Secondary · 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.

Baseline - 20 mg or Less
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention16
Baseline - 21 mg or More
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention3
Week 4 - 20 mg or Less
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention15
Week 4 - 21 mg or More
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention3
Week 8 - 20 mg or Less
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention15
Week 8 - 21 mg or More
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention3
Week 12 - 20 mg or Less
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention14
Week 12 - 21 mg or More
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention4
Fat Intake Secondary · 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.

Baseline
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention29.59± 14.17
Week 4
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention28.49± 9.07
Week 8
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention28.51± 7.59
Week 12
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention25.98± 6.44
Carbohydrate Intake Secondary · 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.

Baseline
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention32.69± 9.42
Week 4
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention32.65± 8.76
Week 8
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention36.12± 11.11
Week 12
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention33.24± 10.17
Weight Secondary · 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.

Basline
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention190.11± 44.57
Week 4
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention189.48± 44.84
Week 8
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention182.88± 38.36
Week 12
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention186.61± 47.02
Systolic Blood Pressure Secondary · 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.

Baseline
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention134.28± 27.46
Week 4
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention137.33± 20.92
Week 8
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention129.89± 26.22
Week 12
GroupValue95% CI
mHealth Dietary App + Health Coaching Intervention128.47± 18.99

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The feasibility of Technology, Application, Self-Management for Kidney (TASK) intervention in post-kidney transplant recipients using a pre/posttest design.
    O'Brien T, Rose K, Focht B, Al Kahlout N, et al · · 2023 · cited 2× · PMID 37993961 · DOI 10.1186/s40814-023-01417-9

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Other recruiting trials for Kidney Transplant

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05151445.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing