Kidney Transplant, Kidney Transplant; Complications
Conditions
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.
Interventions
BEHAVIORALmHealth 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.
Sponsors
Ohio State University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| The Feasibility of Participant Retention for the Study | 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. |
| The Feasibility of Adherence for Using the Lose- It App to Record Diet | Weekly for 12 weeks | Adherence (percent to adhere to logging daily dietary intake) will be recorded continuously each day by the Lose-It app. |
| The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | 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
| Measure | Time frame | Description |
|---|---|---|
| Fat Intake | 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. |
| Carbohydrate Intake | 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. |
| Perceived Stress Level | 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. |
| Systolic Blood Pressure | 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. |
| Diastolic Blood Pressure | 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. |
| Weight | 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. |
| Exercise Self-Efficacy | 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. |
| Fruit and Vegetable Servings Per Day | 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. |
| Fiber Intake | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | mHealth Dietary App + Health Coaching Intervention |
|---|---|
| Age, Continuous | 59.45 years STANDARD_DEVIATION 10.7 |
| Caregiver Parent or legal guardian | 1 Participants |
| Caregiver Self | 18 Participants |
| Caregiver Spouse or partner | 1 Participants |
| Education Associate's or Technical | 5 Participants |
| Education Bachelor's | 7 Participants |
| Education High School Diploma or GED | 4 Participants |
| Education Master's | 4 Participants |
| Employment Full-time employment | 5 Participants |
| Employment Not employed | 9 Participants |
| Employment Retired | 6 Participants |
| Income $126,000 + | 3 Participants |
| Income $20,000-$45,000 | 5 Participants |
| Income $46,000-$65,000 | 5 Participants |
| Income $91,000-$125,000 | 6 Participants |
| Income Under $20,000 | 1 Participants |
| Number of household members 1 | 3 Participants |
| Number of household members 2 | 11 Participants |
| Number of household members 3 | 4 Participants |
| Number of household members 4 | 2 Participants |
| Number of kidney transplants 1 | 18 Participants |
| Number of kidney transplants 2 + | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
| Type of transplant Deceased donor | 14 Participants |
| Type of transplant Living donor | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Adherence (percent to adhere to logging daily physical activity) will be recorded continuously each day by the Lose-It app.
Time frame: Weekly for 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | Week 1 | 5 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | Week 2 | 5 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | Week 3 | 6 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | Week 4 | 5 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | Week 5 | 3 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | Week 6 | 3 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | Week 7 | 5 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | Week 8 | 4 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | Week 9 | 6 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | Week 10 | 5 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | Week 11 | 5 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Physical Actvity | Week 12 | 3 Participants |
Primary
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Adherence (percent to adhere to logging daily dietary intake) will be recorded continuously each day by the Lose-It app.
Time frame: Weekly for 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Record Diet | Week 9 | 17 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Record Diet | Week 10 | 16 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Record Diet | Week 11 | 15 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Record Diet | Week 1 | 17 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Record Diet | Week 2 | 17 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Record Diet | Week 3 | 17 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Record Diet | Week 4 | 16 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Record Diet | Week 5 | 16 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Record Diet | Week 6 | 16 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Record Diet | Week 7 | 15 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Record Diet | Week 8 | 16 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Adherence for Using the Lose- It App to Record Diet | Week 12 | 15 Participants |
Primary
The Feasibility of Participant Retention for the Study
Retention (percent of participants that dropped during the study), will be recorded by the research assistant.
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Participant Retention for the Study | Baseline | 20 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Participant Retention for the Study | 4 weeks | 18 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Participant Retention for the Study | 8 weeks | 18 Participants |
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of Participant Retention for the Study | 12 weeks | 17 Participants |
Primary
The Feasibility of the Study Recruitment for the Study
Recruitment (percent of participants approached to be in the study), will be recorded by the research assistant.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | The Feasibility of the Study Recruitment for the Study | 20 Participants |
Secondary
Carbohydrate Intake
The participant will record their percent of carbohydrate intake each day into the Lose-it Premium application.
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | Carbohydrate Intake | Week 8 | 36.12 percentage of carbohydrate intake | Standard Deviation 11.11 |
| mHealth Dietary App + Health Coaching Intervention | Carbohydrate Intake | Week 12 | 33.24 percentage of carbohydrate intake | Standard Deviation 10.17 |
| mHealth Dietary App + Health Coaching Intervention | Carbohydrate Intake | Baseline | 32.69 percentage of carbohydrate intake | Standard Deviation 9.42 |
| mHealth Dietary App + Health Coaching Intervention | Carbohydrate Intake | Week 4 | 32.65 percentage of carbohydrate intake | Standard Deviation 8.76 |
Comparison: Week 4 vs. Baselinep-value: 0.98995% CI: [-5.25, 5.18]McNemar
Comparison: Week 8 vs. Baselinep-value: 0.26395% CI: [-2.83, 9.69]McNemar
Comparison: Week 12 vs. Baselinep-value: 0.88295% CI: [-5.8, 6.68]McNemar
Secondary
Diastolic Blood Pressure
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.
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | Diastolic Blood Pressure | Baseline | 80.39 millimeters of mercury (mmHg) | Standard Deviation 16.67 |
| mHealth Dietary App + Health Coaching Intervention | Diastolic Blood Pressure | Week 4 | 78.44 millimeters of mercury (mmHg) | Standard Deviation 10.02 |
| mHealth Dietary App + Health Coaching Intervention | Diastolic Blood Pressure | Week 8 | 76.28 millimeters of mercury (mmHg) | Standard Deviation 11.27 |
| mHealth Dietary App + Health Coaching Intervention | Diastolic Blood Pressure | Week 12 | 76.94 millimeters of mercury (mmHg) | Standard Deviation 11.83 |
Comparison: Week 4 vs. Baselinep-value: 0.56895% CI: [-8.99, 5.1]McNemar
Comparison: Week 8 vs. Baselinep-value: 0.19895% CI: [-10.59, 2.37]McNemar
Comparison: Week 12 vs. Baselinep-value: 0.22595% CI: [-10.08, 2.55]McNemar
Secondary
Exercise Self-Efficacy
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.
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | Exercise Self-Efficacy | Baseline | 60.75 score on a scale | Standard Deviation 23.35 |
| mHealth Dietary App + Health Coaching Intervention | Exercise Self-Efficacy | Week 4 | 71.00 score on a scale | Standard Deviation 18.69 |
| mHealth Dietary App + Health Coaching Intervention | Exercise Self-Efficacy | Week 8 | 71.17 score on a scale | Standard Deviation 17.67 |
| mHealth Dietary App + Health Coaching Intervention | Exercise Self-Efficacy | Week 12 | 80.71 score on a scale | Standard Deviation 17.68 |
Comparison: Week 4 vs. Baselinep-value: 0.06295% CI: [-0.55, 19.77]McNemar
Comparison: Week 8 vs. Baselinep-value: 0.09895% CI: [-2.01, 21.56]McNemar
Comparison: Week 12 vs. Baselinep-value: 0.00395% CI: [6.51, 27.6]McNemar
Secondary
Fat Intake
The participant will record their percent of fat intake each day into the Lose-it Premium application.
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | Fat Intake | Baseline | 29.59 percentage of fat intake | Standard Deviation 14.17 |
| mHealth Dietary App + Health Coaching Intervention | Fat Intake | Week 4 | 28.49 percentage of fat intake | Standard Deviation 9.07 |
| mHealth Dietary App + Health Coaching Intervention | Fat Intake | Week 8 | 28.51 percentage of fat intake | Standard Deviation 7.59 |
| mHealth Dietary App + Health Coaching Intervention | Fat Intake | Week 12 | 25.98 percentage of fat intake | Standard Deviation 6.44 |
Comparison: Week 4 vs. Baselinep-value: 0.69695% CI: [-6.96, 4.76]McNemar
Comparison: Week 8 vs. Baselinep-value: 0.73495% CI: [-7.72, 5.56]McNemar
Comparison: Week 12 vs. Baselinep-value: 0.24995% CI: [-11.53, 3.23]McNemar
Secondary
Fiber Intake
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.
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | Fiber Intake | Baseline - 20 mg or Less | 16 Participants |
| mHealth Dietary App + Health Coaching Intervention | Fiber Intake | Baseline - 21 mg or More | 3 Participants |
| mHealth Dietary App + Health Coaching Intervention | Fiber Intake | Week 4 - 20 mg or Less | 15 Participants |
| mHealth Dietary App + Health Coaching Intervention | Fiber Intake | Week 4 - 21 mg or More | 3 Participants |
| mHealth Dietary App + Health Coaching Intervention | Fiber Intake | Week 8 - 20 mg or Less | 15 Participants |
| mHealth Dietary App + Health Coaching Intervention | Fiber Intake | Week 8 - 21 mg or More | 3 Participants |
| mHealth Dietary App + Health Coaching Intervention | Fiber Intake | Week 12 - 20 mg or Less | 14 Participants |
| mHealth Dietary App + Health Coaching Intervention | Fiber Intake | Week 12 - 21 mg or More | 4 Participants |
Comparison: Week 4 vs. Baselinep-value: 1McNemar
Comparison: Week 8 vs. Baselinep-value: 1McNemar
Comparison: Weel 12 vs. Baselinep-value: 1McNemar
Secondary
Fruit and Vegetable Servings Per Day
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.
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | Fruit and Vegetable Servings Per Day | Baseline - 2 Servings or Less | 11 servings of fruit and vegetables per day |
| mHealth Dietary App + Health Coaching Intervention | Fruit and Vegetable Servings Per Day | Basline - 3 Servings or More | 8 servings of fruit and vegetables per day |
| mHealth Dietary App + Health Coaching Intervention | Fruit and Vegetable Servings Per Day | Week 4 - 2 Servings or Less | 8 servings of fruit and vegetables per day |
| mHealth Dietary App + Health Coaching Intervention | Fruit and Vegetable Servings Per Day | Week 4 - 3 Servings or More | 10 servings of fruit and vegetables per day |
| mHealth Dietary App + Health Coaching Intervention | Fruit and Vegetable Servings Per Day | Week 8 - 2 Servings or Less | 9 servings of fruit and vegetables per day |
| mHealth Dietary App + Health Coaching Intervention | Fruit and Vegetable Servings Per Day | Week 8 - 3 Servings or More | 9 servings of fruit and vegetables per day |
| mHealth Dietary App + Health Coaching Intervention | Fruit and Vegetable Servings Per Day | Week 12 - 2 Servings or Less | 7 servings of fruit and vegetables per day |
| mHealth Dietary App + Health Coaching Intervention | Fruit and Vegetable Servings Per Day | Week 12 - 3 Servings or More | 10 servings of fruit and vegetables per day |
Comparison: Week 4 vs. Baselinep-value: 0.37McNemar
Comparison: Week 8 vs. Baselinep-value: 0.724McNemar
Comparison: Week 12 vs. Baselinep-value: 0.289McNemar
Secondary
Perceived Stress Level
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.
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Population: There were some participants who withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | Perceived Stress Level | Baseline | 21.65 score on a scale | Standard Deviation 3.88 |
| mHealth Dietary App + Health Coaching Intervention | Perceived Stress Level | Week 4 | 17.56 score on a scale | Standard Deviation 5.03 |
| mHealth Dietary App + Health Coaching Intervention | Perceived Stress Level | Week 8 | 18.00 score on a scale | Standard Deviation 4.79 |
| mHealth Dietary App + Health Coaching Intervention | Perceived Stress Level | Week 12 | 18.82 score on a scale | Standard Deviation 5.27 |
Comparison: Week 4 vs. Baselinep-value: 0.00295% CI: [-5.65, -1.46]McNemar
Comparison: Week 8 vs. Baselinep-value: 0.00495% CI: [-5.07, -1.15]McNemar
Comparison: Week 12 vs. Baselinep-value: 0.03895% CI: [-4.9, 0.16]McNemar
Secondary
Systolic Blood Pressure
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.
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | Systolic Blood Pressure | Week 12 | 128.47 millimeters of mercury (mmHg) | Standard Deviation 18.99 |
| mHealth Dietary App + Health Coaching Intervention | Systolic Blood Pressure | Baseline | 134.28 millimeters of mercury (mmHg) | Standard Deviation 27.46 |
| mHealth Dietary App + Health Coaching Intervention | Systolic Blood Pressure | Week 4 | 137.33 millimeters of mercury (mmHg) | Standard Deviation 20.92 |
| mHealth Dietary App + Health Coaching Intervention | Systolic Blood Pressure | Week 8 | 129.89 millimeters of mercury (mmHg) | Standard Deviation 26.22 |
Comparison: Week 4 vs. Baselinep-value: 0.42995% CI: [-4.9, 11.01]McNemar
Comparison: Week 8 vs. Baselinep-value: 0.25595% CI: [-12.24, 3.46]McNemar
Comparison: Week 12 vs. Baselinep-value: 0.10295% CI: [-15.55, 1.55]McNemar
Secondary
Weight
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.
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mHealth Dietary App + Health Coaching Intervention | Weight | Basline | 190.11 pounds | Standard Deviation 44.57 |
| mHealth Dietary App + Health Coaching Intervention | Weight | Week 4 | 189.48 pounds | Standard Deviation 44.84 |
| mHealth Dietary App + Health Coaching Intervention | Weight | Week 8 | 182.88 pounds | Standard Deviation 38.36 |
| mHealth Dietary App + Health Coaching Intervention | Weight | Week 12 | 186.61 pounds | Standard Deviation 47.02 |
Comparison: Week 4 vs. Baselinep-value: 0.42595% CI: [-2.23, 0.98]McNemar
Comparison: Week 8 vs. Baselinep-value: 0.20595% CI: [-9.08, -0.88]McNemar
Comparison: Week 12 vs. Baselinep-value: 0.0295% CI: [-9.08, -0.8]McNemar