Clinical trial NCT05151445: The Use of a Consumer-Based mHealth Dietary App and Health Coaching With Kidney Transplant Recipients
Official title: The Use of a Consumer-Based mHealth Dietary App and Health Coaching With Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant
Kidney Transplant; Complications
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Feasibility of the Study Recruitment for the Study
timeFrame: Baseline
measure: The Feasibility of Participant Retention for the Study
timeFrame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: The Feasibility of Adherence for Using the Lose- It App to Record Diet
timeFrame: Weekly for 12 weeks
measure: The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
timeFrame: Weekly for 12 weeks
Secondary outcomes:
measure: Perceived Stress Level
timeFrame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Exercise Self-Efficacy
timeFrame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Fruit and Vegetable Servings Per Day
timeFrame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Fiber Intake
timeFrame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Fat Intake
timeFrame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Carbohydrate Intake
timeFrame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Weight
timeFrame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Systolic Blood Pressure
timeFrame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Diastolic Blood Pressure
timeFrame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
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