Trial Outcomes & Findings for The Use of a Consumer-Based mHealth Dietary App and Health Coaching With Kidney Transplant Recipients (NCT NCT05151445)
NCT ID: NCT05151445
Last Updated: 2024-10-28
Results Overview
Recruitment (percent of participants approached to be in the study), will be recorded by the research assistant.
Recruitment status
COMPLETED
Target enrollment
20 participants
Primary outcome timeframe
Baseline
Results posted on
2024-10-28
Participant Flow
Recruitment of of participatns took place among patients who received care at a Midwest Medical Center Kidney Transplant Clinic or attended a Midwest transplant support group over four months using a convenience sampling strategy. Eligibility criteria for this study consisted of KRs, age 18 years or older, not on dialysis, the ability to speak and hear English, and possession of a smartphone capable of accessing and downloading mobile applications (apps), Wi-Fi, or Internet access.
Participants were not eligible for this study if they were participating in a weight loss or structured exercise program or could not pass a brief cognitive test.
Participant milestones
| Measure |
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.
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.
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|---|---|
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Overall Study
STARTED
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20
|
|
Overall Study
Week 4
|
18
|
|
Overall Study
Week 8
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
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.
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|---|---|
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Overall Study
Withdrawal by Subject
|
3
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Baseline Characteristics
The Use of a Consumer-Based mHealth Dietary App and Health Coaching With Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=20 Participants
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.
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.
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|---|---|
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Age, Continuous
|
59.45 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
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10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Employment
Full-time employment
|
5 Participants
n=5 Participants
|
|
Employment
Not employed
|
9 Participants
n=5 Participants
|
|
Employment
Retired
|
6 Participants
n=5 Participants
|
|
Number of kidney transplants
1
|
18 Participants
n=5 Participants
|
|
Number of kidney transplants
2 +
|
2 Participants
n=5 Participants
|
|
Type of transplant
Deceased donor
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14 Participants
n=5 Participants
|
|
Type of transplant
Living donor
|
6 Participants
n=5 Participants
|
|
Caregiver
Self
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18 Participants
n=5 Participants
|
|
Caregiver
Spouse or partner
|
1 Participants
n=5 Participants
|
|
Caregiver
Parent or legal guardian
|
1 Participants
n=5 Participants
|
|
Number of household members
1
|
3 Participants
n=5 Participants
|
|
Number of household members
2
|
11 Participants
n=5 Participants
|
|
Number of household members
3
|
4 Participants
n=5 Participants
|
|
Number of household members
4
|
2 Participants
n=5 Participants
|
|
Income
Under $20,000
|
1 Participants
n=5 Participants
|
|
Income
$20,000-$45,000
|
5 Participants
n=5 Participants
|
|
Income
$46,000-$65,000
|
5 Participants
n=5 Participants
|
|
Income
$91,000-$125,000
|
6 Participants
n=5 Participants
|
|
Income
$126,000 +
|
3 Participants
n=5 Participants
|
|
Education
High School Diploma or GED
|
4 Participants
n=5 Participants
|
|
Education
Associate's or Technical
|
5 Participants
n=5 Participants
|
|
Education
Bachelor's
|
7 Participants
n=5 Participants
|
|
Education
Master's
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineRecruitment (percent of participants approached to be in the study), will be recorded by the research assistant.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=20 Participants
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.
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.
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The Feasibility of the Study Recruitment for the Study
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20 Participants
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PRIMARY outcome
Timeframe: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeksRetention (percent of participants that dropped during the study), will be recorded by the research assistant.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=20 Participants
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.
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.
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|---|---|
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The Feasibility of Participant Retention for the Study
Baseline
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20 Participants
|
|
The Feasibility of Participant Retention for the Study
4 weeks
|
18 Participants
|
|
The Feasibility of Participant Retention for the Study
8 weeks
|
18 Participants
|
|
The Feasibility of Participant Retention for the Study
12 weeks
|
17 Participants
|
PRIMARY outcome
Timeframe: Weekly for 12 weeksAdherence (percent to adhere to logging daily dietary intake) will be recorded continuously each day by the "Lose-It" app.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=18 Participants
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.
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.
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|---|---|
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The Feasibility of Adherence for Using the Lose- It App to Record Diet
Week 1
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17 Participants
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The Feasibility of Adherence for Using the Lose- It App to Record Diet
Week 2
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17 Participants
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|
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Week 3
|
17 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Week 4
|
16 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Week 5
|
16 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Week 6
|
16 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Week 7
|
15 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Week 8
|
16 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Week 9
|
17 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Week 10
|
16 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Week 11
|
15 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Week 12
|
15 Participants
|
PRIMARY outcome
Timeframe: Weekly for 12 weeksAdherence (percent to adhere to logging daily physical activity) will be recorded continuously each day by the "Lose-It" app.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=18 Participants
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.
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.
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|---|---|
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The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Week 1
|
5 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Week 2
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5 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Week 3
|
6 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Week 4
|
5 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Week 5
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3 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Week 6
|
3 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Week 7
|
5 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Week 8
|
4 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Week 9
|
6 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Week 10
|
5 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Week 11
|
5 Participants
|
|
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Week 12
|
3 Participants
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeksPopulation: There were some participants who withdrew from the study over time.
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.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=20 Participants
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.
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.
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|---|---|
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Perceived Stress Level
Baseline
|
21.65 score on a scale
Standard Deviation 3.88
|
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Perceived Stress Level
Week 4
|
17.56 score on a scale
Standard Deviation 5.03
|
|
Perceived Stress Level
Week 8
|
18.00 score on a scale
Standard Deviation 4.79
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Perceived Stress Level
Week 12
|
18.82 score on a scale
Standard Deviation 5.27
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SECONDARY outcome
Timeframe: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeksExercise 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.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=20 Participants
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.
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.
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|---|---|
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Exercise Self-Efficacy
Baseline
|
60.75 score on a scale
Standard Deviation 23.35
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Exercise Self-Efficacy
Week 4
|
71.00 score on a scale
Standard Deviation 18.69
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Exercise Self-Efficacy
Week 8
|
71.17 score on a scale
Standard Deviation 17.67
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Exercise Self-Efficacy
Week 12
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80.71 score on a scale
Standard Deviation 17.68
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SECONDARY outcome
Timeframe: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeksFruit 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.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=20 Participants
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.
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.
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Fruit and Vegetable Servings Per Day
Week 4 - 2 Servings or Less
|
8 servings of fruit and vegetables per day
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Fruit and Vegetable Servings Per Day
Baseline - 2 Servings or Less
|
11 servings of fruit and vegetables per day
|
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Fruit and Vegetable Servings Per Day
Basline - 3 Servings or More
|
8 servings of fruit and vegetables per day
|
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Fruit and Vegetable Servings Per Day
Week 4 - 3 Servings or More
|
10 servings of fruit and vegetables per day
|
|
Fruit and Vegetable Servings Per Day
Week 8 - 2 Servings or Less
|
9 servings of fruit and vegetables per day
|
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Fruit and Vegetable Servings Per Day
Week 8 - 3 Servings or More
|
9 servings of fruit and vegetables per day
|
|
Fruit and Vegetable Servings Per Day
Week 12 - 2 Servings or Less
|
7 servings of fruit and vegetables per day
|
|
Fruit and Vegetable Servings Per Day
Week 12 - 3 Servings or More
|
10 servings of fruit and vegetables per day
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SECONDARY outcome
Timeframe: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeksFiber 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.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=20 Participants
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.
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.
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|---|---|
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Fiber Intake
Week 4 - 21 mg or More
|
3 Participants
|
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Fiber Intake
Week 8 - 20 mg or Less
|
15 Participants
|
|
Fiber Intake
Week 8 - 21 mg or More
|
3 Participants
|
|
Fiber Intake
Week 12 - 20 mg or Less
|
14 Participants
|
|
Fiber Intake
Week 12 - 21 mg or More
|
4 Participants
|
|
Fiber Intake
Baseline - 20 mg or Less
|
16 Participants
|
|
Fiber Intake
Baseline - 21 mg or More
|
3 Participants
|
|
Fiber Intake
Week 4 - 20 mg or Less
|
15 Participants
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeksThe participant will record their percent of fat intake each day into the Lose-it Premium application.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=20 Participants
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.
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.
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|---|---|
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Fat Intake
Baseline
|
29.59 percentage of fat intake
Standard Deviation 14.17
|
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Fat Intake
Week 4
|
28.49 percentage of fat intake
Standard Deviation 9.07
|
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Fat Intake
Week 8
|
28.51 percentage of fat intake
Standard Deviation 7.59
|
|
Fat Intake
Week 12
|
25.98 percentage of fat intake
Standard Deviation 6.44
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeksThe participant will record their percent of carbohydrate intake each day into the Lose-it Premium application.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=20 Participants
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.
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.
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|---|---|
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Carbohydrate Intake
Baseline
|
32.69 percentage of carbohydrate intake
Standard Deviation 9.42
|
|
Carbohydrate Intake
Week 4
|
32.65 percentage of carbohydrate intake
Standard Deviation 8.76
|
|
Carbohydrate Intake
Week 8
|
36.12 percentage of carbohydrate intake
Standard Deviation 11.11
|
|
Carbohydrate Intake
Week 12
|
33.24 percentage of carbohydrate intake
Standard Deviation 10.17
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeksWeight (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.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=20 Participants
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.
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.
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|---|---|
|
Weight
Basline
|
190.11 pounds
Standard Deviation 44.57
|
|
Weight
Week 4
|
189.48 pounds
Standard Deviation 44.84
|
|
Weight
Week 8
|
182.88 pounds
Standard Deviation 38.36
|
|
Weight
Week 12
|
186.61 pounds
Standard Deviation 47.02
|
SECONDARY outcome
Timeframe: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeksSystolic 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.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=20 Participants
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.
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.
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|---|---|
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Systolic Blood Pressure
Week 12
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128.47 millimeters of mercury (mmHg)
Standard Deviation 18.99
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Systolic Blood Pressure
Baseline
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134.28 millimeters of mercury (mmHg)
Standard Deviation 27.46
|
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Systolic Blood Pressure
Week 4
|
137.33 millimeters of mercury (mmHg)
Standard Deviation 20.92
|
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Systolic Blood Pressure
Week 8
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129.89 millimeters of mercury (mmHg)
Standard Deviation 26.22
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SECONDARY outcome
Timeframe: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeksSystolic 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.
Outcome measures
| Measure |
mHealth Dietary App + Health Coaching Intervention
n=20 Participants
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.
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.
|
|---|---|
|
Diastolic Blood Pressure
Baseline
|
80.39 millimeters of mercury (mmHg)
Standard Deviation 16.67
|
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Diastolic Blood Pressure
Week 4
|
78.44 millimeters of mercury (mmHg)
Standard Deviation 10.02
|
|
Diastolic Blood Pressure
Week 8
|
76.28 millimeters of mercury (mmHg)
Standard Deviation 11.27
|
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Diastolic Blood Pressure
Week 12
|
76.94 millimeters of mercury (mmHg)
Standard Deviation 11.83
|
Adverse Events
mHealth Dietary App + Health Coaching Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place