Hypertension, Blood Pressure, Lifestyle Risk Reduction
Conditions
Keywords
Hypertension, Young Adult, Self-Management, Health coach
Brief summary
This is a 5-year randomized controlled trial in two large healthcare systems (Madison and Milwaukee, WI) to evaluate MyHEART's (My Hypertension Education And Reaching Target) impact on blood pressure among 310 geographically and racially/ethnically diverse young adults.
Detailed description
Aim 1. To evaluate the effect of MyHEART (home blood pressure monitor distribution and heath coaching) on clinical outcomes, the change in systolic and diastolic blood pressure (primary) and hypertension control (secondary) after 6 and 12 months, compared to usual clinical care. Aim 2. To evaluate the effect of MyHEART on hypertension self-management behavior (behavioral outcomes) at 6 and 12 months, compared to usual clinical care. Aim 3. To examine whether MyHEART's effects on self-management behavior are mediated through variables of perceived competence, autonomy, motivation, and activation (mediation outcomes).
Interventions
BEHAVIORALHome Blood Pressure Monitoring
Intervention arm participants will receive a home blood pressure monitor, home blood pressure log, and training on accurate home monitoring. They will be asked to share their home blood pressure readings during health coach telephone calls.
BEHAVIORALTelephone Health Coaching
Intervention arm participants will receive a health coach phone call every 2 weeks for 6 months, for a total of 12 calls. During each call, the health coach will review and discuss home blood pressures and address barriers and concerns to hypertension management. During each telephone call, the coach will guide the participant on selecting health behavior goals. Intervention arm participants will also receive handouts about hypertension management during the study visits and after health coach calls.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Wake Forest University Health Sciences
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Willing and capable of giving written informed consent * Willing to comply with all study procedures and be available for the duration of the study * Males and females ages 18-39 years old at the start of the study (inclusive) * A minimum of two hypertension ICD-10 coded visits with a provider (physician \[MD, DO\], physician assistant, nurse practitioner) on different dates in the last 24 months, with at least one code in the past 18 months * Medically homed at an IRB approved healthcare system
Exclusion criteria
* History of medically determined Congestive Heart Failure * Unable to provide informed consent (i.e., activated healthcare power of attorney) * Unable or unwilling to travel to local clinic for research visits * Currently residing in a skilled nursing facility * Diagnosed with sickle cell anemia or cystic fibrosis * Diagnosed with stroke, myocardial infarction, and/or coronary artery revascularization in the past 2 years * Syncope while exercising or doing strenuous activity within past 12 months * Currently prescribed warfarin, novel oral anticoagulant, or insulin * Planned organ transplant or prior transplant in the past 5 years * Chemotherapy or radiation therapy within 6 the past months * Severely impaired hearing, vision, or speech, as determined by study staff responsible for enrollment * Current participation or planning to participate in another clinical trial in the next 12 months * Pregnant or planning to become pregnant in the next 12 months * Planning to leave the geographic area in the next 6 months * Health condition that will limit both increasing physical activity and changing diet * Illegal drug use (other than marijuana) in the past 30 days * Unable to read or communicate in English * Currently on dialysis or seeing a Nephrologist * Unaware or denies history of high blood pressure or hypertension * Between-arm blood pressure difference \>20 mmHg * White Coat Hypertension (24-hour ambulatory monitoring) * Inability to comply with or complete the protocol or other reasons at the discretion of the principal and site investigators * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinic Diastolic Blood Pressure (mmHg) | baseline, 6 month, and 12 month follow-up | Clinic Diastolic Blood Pressure measured at baseline, 6 months, and 12 months. |
| Clinic Systolic Blood Pressure (mmHg) | baseline, 6 month, and 12 month follow-up | Systolic Blood Pressure measured at baseline, 6 months, and 12 months. |
| 24-hour Diastolic Ambulatory Blood Pressure (mmHg) | baseline, 6 month, and 12 month follow-up | 24-hour Diastolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months. |
| 24-hour Systolic Ambulatory Blood Pressure (mmHg) | baseline, 6 month, and 12 month follow-up | 24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | baseline, 6 month, and 12 month follow-up | Ounces of whole grain measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment |
| Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | baseline, 6 month, and 12 month follow-up | Saturated fat measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in percent kilocalories |
| Physical Activity as Assessed by the Godin Physical Activity Questionnaire | baseline, 6 month, and 12 month follow-up | Mean weekly amounts of physical activity as assessed by the Godin Physical Activity Questionnaire. The Godin Physical Activity Questionnaire measures a person's strenuous, moderate, and light physical activity in a week. Scoring is calculated as follows (units are times per week that the participant engaged in any of the 3 classifications of activity longer than 15 minutes during their free time): * 9 x strenous units reported + 5 x moderate units reported + 3 x light units reported = score A minimum score of 0 indicates no activity, a score of less than 14 is interpreted as insufficiently active or sedentary, a score between 14 and 23 is interpreted to be moderately active, and a score of 24 and higher is interpreted to be active, a theoretical maximum does not exist. |
| Home Blood Pressure Monitoring Frequency | baseline, 6 month, and 12 month follow-up | Self-report of home blood pressure monitoring frequency measured at baseline, 6 months, and 12 months. |
| Standing Weight (kg) | baseline, 6 month, and 12 month follow-up | Weight (kg) measured at baseline, 6 months, and 12 months. |
| Perceived Competence as Assessed by the Perceived Competence Scale for Diet | baseline, 6 month, and 12 month follow-up | Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence. |
| Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet | baseline, 6 month, and 12 month follow-up | Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy. |
| Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise | baseline, 6 month, and 12 month follow-up | Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy. |
| Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | baseline, 6 month, and 12 month follow-up | Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation. |
| Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | baseline, 6 month, and 12 month follow-up | Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation. |
| Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | baseline, 6 month, and 12 month follow-up | Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation. |
| Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | baseline, 6 month, and 12 month follow-up | Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation. |
| Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | baseline, 6 month, and 12 month follow-up | Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation. |
| Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | baseline, 6 month, and 12 month follow-up | Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation. |
| Perceived Competence as Assessed by the Perceived Competence Scale for Exercise | baseline, 6 month, and 12 month follow-up | Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence. |
| Number of Participants That Achieve Hypertension Control at 6 Months | up to 6 months | Hypertension Control: Percentage of participants that achieve hypertension control at 6 months. Hypertension control will be defined using ambulatory blood pressures as the gold standard (\<130/80 mmHg); otherwise a clinic blood pressure of \<140/90 mmHg will be used. |
| Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | baseline, 6 month, and 12 month follow-up | Mean daily sodium intake (milligrams/day) at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment |
| Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | baseline, 6 month, and 12 month follow-up | Mean number of combined fruit and vegetable servings measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in cups equivalent. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Coach Fidelity to the Study Intervention | through completion of administering the study intervention, an average of 4 years | Evaluation of health coach fidelity to administering the motivational interviewing intervention per protocol will be assessed every 2 months using a modified Behavior Change Counseling Index |
| Withdrawal | Through study completion, an average of 5 years | Subject Withdrawal Rate |
| Serious Adverse Events | Through study completion, an average of 5 years | Number and type of serious adverse events |
| Adverse Events | Through study completion, an average of 5 years | Number and type of adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials. | 157 |
| Usual Clinical Care Usual care arm participants will receive routine hypertension clinical care per their primary care provider. | 159 |
| Total | 316 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 41 | 47 |
| Overall Study | Physician Decision | 6 | 7 |
| Overall Study | Withdrawal by Subject | 24 | 15 |
Baseline characteristics
| Characteristic | Usual Clinical Care | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 33.7 years | 33.8 years | 33.8 years |
| Alcohol Beverages per week | 5.1 servings of alcohol per week | 5.2 servings of alcohol per week | 5.3 servings of alcohol per week |
| Ambulatory Diastolic Blood Pressure (BP) | 87.0 mmHg | 86.7 mmHg | 86.5 mmHg |
| Ambulatory Systolic BP | 133.0 mmHg | 132.8 mmHg | 132.6 mmHg |
| Body Mass Index (BMI) | 34.5 kg/m^2 | 34.5 kg/m^2 | 34.5 kg/m^2 |
| Cigarette Tobacco Status Currently Smoke Cigarettes | 19 Participants | 40 Participants | 21 Participants |
| Cigarette Tobacco Status Have Never Smoked Cigarettes | 115 Participants | 212 Participants | 97 Participants |
| Cigarette Tobacco Status Unknown | 0 Participants | 5 Participants | 5 Participants |
| Cigarette Tobacco Status Used to Smoke Cigarettes | 25 Participants | 59 Participants | 34 Participants |
| Comorbidities Anxiety and / or Depression | 78 Participants | 160 Participants | 82 Participants |
| Comorbidities Chronic Kidney Disease | 2 Participants | 3 Participants | 1 Participants |
| Comorbidities Diabetes | 9 Participants | 18 Participants | 9 Participants |
| Comorbidities Dyslipidemia | 32 Participants | 73 Participants | 41 Participants |
| Comorbidities Other Chronic Comorbidity | 59 Participants | 121 Participants | 62 Participants |
| Godin-Shephard Physical Activity Active | 81 Participants | 149 Participants | 68 Participants |
| Godin-Shephard Physical Activity Insufficiently Active | 78 Participants | 162 Participants | 84 Participants |
| Godin-Shephard Physical Activity Unknown | 0 Participants | 5 Participants | 5 Participants |
| Highest Level of Education I have completed High School | 20 Participants | 42 Participants | 22 Participants |
| Highest Level of Education I have finished College or Vocational School | 74 Participants | 137 Participants | 63 Participants |
| Highest Level of Education I have not finished College or Vocational School | 24 Participants | 52 Participants | 28 Participants |
| Highest Level of Education I have not finished High School | 8 Participants | 15 Participants | 7 Participants |
| Highest Level of Education Some / Completed Graduate of Professional School | 33 Participants | 65 Participants | 32 Participants |
| Highest Level of Education Unknown | 0 Participants | 5 Participants | 5 Participants |
| Marital Status Divorced / Widower | 4 Participants | 7 Participants | 3 Participants |
| Marital Status Married / Partnered | 101 Participants | 200 Participants | 99 Participants |
| Marital Status Single | 54 Participants | 104 Participants | 50 Participants |
| Marital Status Unknown | 0 Participants | 5 Participants | 5 Participants |
| Number of Antihypertensive Medications 0 | 78 Participants | 162 Participants | 84 Participants |
| Number of Antihypertensive Medications 1 | 51 Participants | 97 Participants | 46 Participants |
| Number of Antihypertensive Medications 2 | 21 Participants | 43 Participants | 22 Participants |
| Number of Antihypertensive Medications 3 | 8 Participants | 11 Participants | 3 Participants |
| Number of Antihypertensive Medications greater than or equal to 4 | 1 Participants | 3 Participants | 2 Participants |
| Number of Children at Home | 1.0 children | 1.0 children | 1.1 children |
| Office Diastolic BP | 91.8 mmHg | 91.3 mmHg | 90.8 mmHg |
| Office Systolic BP | 138.0 mmHg | 138.1 mmHg | 138.3 mmHg |
| Race/Ethnicity, Customized Black | 35 Participants | 72 Participants | 37 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 22 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 115 Participants | 222 Participants | 107 Participants |
| Region of Enrollment United States | 159 participants | 316 participants | 157 participants |
| Risk Factors E-Cigarette / Vaping Use in the past 6 months | 13 Participants | 26 Participants | 13 Participants |
| Risk Factors Ever Been on Medicaid | 33 Participants | 67 Participants | 34 Participants |
| Risk Factors Family History of Heart Disease or Stroke | 61 Participants | 113 Participants | 52 Participants |
| Risk Factors Financial Status: Inadequate Income | 122 Participants | 248 Participants | 126 Participants |
| Self-Perceived Health Status Excellent | 4 Participants | 7 Participants | 3 Participants |
| Self-Perceived Health Status Fair | 50 Participants | 111 Participants | 61 Participants |
| Self-Perceived Health Status Poor or No Response | 21 Participants | 39 Participants | 18 Participants |
| Self-Perceived Health Status Unknown | 1 Participants | 6 Participants | 5 Participants |
| Self-Perceived Health Status Very Good or Good | 83 Participants | 153 Participants | 70 Participants |
| Sex/Gender, Customized Female | 74 Participants | 145 Participants | 71 Participants |
| Sex/Gender, Customized Male | 85 Participants | 166 Participants | 81 Participants |
| Sex/Gender, Customized Unknown | 0 Participants | 5 Participants | 5 Participants |
| Waist Circumference | 109.4 centimeters | 109.4 centimeters | 109.5 centimeters |
| Weight | 103.3 kilograms | 103.2 kilograms | 103.1 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 157 | 1 / 159 |
| other Total, other adverse events | 56 / 157 | 38 / 159 |
| serious Total, serious adverse events | 3 / 157 | 5 / 159 |
Outcome results
Primary
24-hour Diastolic Ambulatory Blood Pressure (mmHg)
24-hour Diastolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | 24-hour Diastolic Ambulatory Blood Pressure (mmHg) | baseline | 86.45 mmHg | Standard Deviation 7.76 |
| Intervention | 24-hour Diastolic Ambulatory Blood Pressure (mmHg) | 6 months | 84.61 mmHg | Standard Deviation 8.24 |
| Intervention | 24-hour Diastolic Ambulatory Blood Pressure (mmHg) | 12 months | 85.34 mmHg | Standard Deviation 9.32 |
| Usual Clinical Care | 24-hour Diastolic Ambulatory Blood Pressure (mmHg) | baseline | 87.04 mmHg | Standard Deviation 8.16 |
| Usual Clinical Care | 24-hour Diastolic Ambulatory Blood Pressure (mmHg) | 6 months | 85.89 mmHg | Standard Deviation 9.19 |
| Usual Clinical Care | 24-hour Diastolic Ambulatory Blood Pressure (mmHg) | 12 months | 85.52 mmHg | Standard Deviation 9.43 |
Primary
24-hour Systolic Ambulatory Blood Pressure (mmHg)
24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Intervention | 24-hour Systolic Ambulatory Blood Pressure (mmHg) | baseline | 132.59 mmHg | Standard Deviation 11.36 |
| Intervention | 24-hour Systolic Ambulatory Blood Pressure (mmHg) | 6 month | 128.14 mmHg | Standard Deviation 11.36 |
| Intervention | 24-hour Systolic Ambulatory Blood Pressure (mmHg) | 12 month | 128.54 mmHg | Standard Deviation 11.95 |
| Usual Clinical Care | 24-hour Systolic Ambulatory Blood Pressure (mmHg) | baseline | 133.01 mmHg | Standard Deviation 12.67 |
| Usual Clinical Care | 24-hour Systolic Ambulatory Blood Pressure (mmHg) | 6 month | 130.69 mmHg | Standard Deviation 13.99 |
| Usual Clinical Care | 24-hour Systolic Ambulatory Blood Pressure (mmHg) | 12 month | 129.47 mmHg | Standard Deviation 14.71 |
Primary
Clinic Diastolic Blood Pressure (mmHg)
Clinic Diastolic Blood Pressure measured at baseline, 6 months, and 12 months.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Clinic Diastolic Blood Pressure (mmHg) | baseline | 90.81 mmHg | Standard Deviation 11.42 |
| Intervention | Clinic Diastolic Blood Pressure (mmHg) | 6 months | 83.83 mmHg | Standard Deviation 9.36 |
| Intervention | Clinic Diastolic Blood Pressure (mmHg) | 12 months | 85.05 mmHg | Standard Deviation 10.56 |
| Usual Clinical Care | Clinic Diastolic Blood Pressure (mmHg) | baseline | 91.77 mmHg | Standard Deviation 11.26 |
| Usual Clinical Care | Clinic Diastolic Blood Pressure (mmHg) | 6 months | 86.70 mmHg | Standard Deviation 12.44 |
| Usual Clinical Care | Clinic Diastolic Blood Pressure (mmHg) | 12 months | 85.15 mmHg | Standard Deviation 12.31 |
Primary
Clinic Systolic Blood Pressure (mmHg)
Systolic Blood Pressure measured at baseline, 6 months, and 12 months.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Clinic Systolic Blood Pressure (mmHg) | baseline | 138.30 mmHg | Standard Deviation 14.27 |
| Intervention | Clinic Systolic Blood Pressure (mmHg) | 6 month | 130.84 mmHg | Standard Deviation 12.16 |
| Intervention | Clinic Systolic Blood Pressure (mmHg) | 12 month | 131.16 mmHg | Standard Deviation 12.77 |
| Usual Clinical Care | Clinic Systolic Blood Pressure (mmHg) | 6 month | 132.50 mmHg | Standard Deviation 15.83 |
| Usual Clinical Care | Clinic Systolic Blood Pressure (mmHg) | baseline | 137.97 mmHg | Standard Deviation 14.33 |
| Usual Clinical Care | Clinic Systolic Blood Pressure (mmHg) | 12 month | 130.7 mmHg | Standard Deviation 15.22 |
Secondary
Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet
Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | baseline | 2.30 score on a scale | Standard Deviation 1.11 |
| Intervention | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | 6 months | 2.29 score on a scale | Standard Deviation 1.04 |
| Intervention | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | 12 months | 2.47 score on a scale | Standard Deviation 1.12 |
| Usual Clinical Care | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | baseline | 2.37 score on a scale | Standard Deviation 1.09 |
| Usual Clinical Care | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | 6 months | 2.45 score on a scale | Standard Deviation 1.16 |
| Usual Clinical Care | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | 12 months | 2.35 score on a scale | Standard Deviation 1.09 |
Secondary
Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise
Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | baseline | 2.27 score on a scale | Standard Deviation 1.09 |
| Intervention | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | 6 months | 2.27 score on a scale | Standard Deviation 1.07 |
| Intervention | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | 12 months | 2.55 score on a scale | Standard Deviation 1.17 |
| Usual Clinical Care | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | 12 months | 2.34 score on a scale | Standard Deviation 1.08 |
| Usual Clinical Care | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | baseline | 2.31 score on a scale | Standard Deviation 1.08 |
| Usual Clinical Care | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | 6 months | 2.46 score on a scale | Standard Deviation 1.18 |
Secondary
Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet
Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | baseline | 5.80 score on a scale | Standard Deviation 1.02 |
| Intervention | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | 6 months | 5.86 score on a scale | Standard Deviation 1.02 |
| Intervention | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | 12 months | 5.78 score on a scale | Standard Deviation 1.02 |
| Usual Clinical Care | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | baseline | 5.80 score on a scale | Standard Deviation 1.06 |
| Usual Clinical Care | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | 6 months | 5.76 score on a scale | Standard Deviation 1.02 |
| Usual Clinical Care | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | 12 months | 5.85 score on a scale | Standard Deviation 0.95 |
Secondary
Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise
Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | baseline | 5.81 score on a scale | Standard Deviation 1.04 |
| Intervention | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | 6 months | 5.94 score on a scale | Standard Deviation 1 |
| Intervention | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | 12 months | 5.79 score on a scale | Standard Deviation 1.06 |
| Usual Clinical Care | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | baseline | 5.81 score on a scale | Standard Deviation 1.07 |
| Usual Clinical Care | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | 6 months | 5.74 score on a scale | Standard Deviation 1.03 |
| Usual Clinical Care | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | 12 months | 5.83 score on a scale | Standard Deviation 1.04 |
Secondary
Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet
Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | baseline | 3.19 score on a scale | Standard Deviation 1.25 |
| Intervention | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | 6 months | 3.30 score on a scale | Standard Deviation 1.09 |
| Intervention | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | 12 months | 3.36 score on a scale | Standard Deviation 1.11 |
| Usual Clinical Care | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | baseline | 3.04 score on a scale | Standard Deviation 1.23 |
| Usual Clinical Care | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | 6 months | 3.23 score on a scale | Standard Deviation 1.29 |
| Usual Clinical Care | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | 12 months | 3.39 score on a scale | Standard Deviation 1.31 |
Secondary
Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise
Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | baseline | 3.20 score on a scale | Standard Deviation 1.23 |
| Intervention | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | 6 months | 3.28 score on a scale | Standard Deviation 1.24 |
| Intervention | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | 12 months | 3.17 score on a scale | Standard Deviation 1.16 |
| Usual Clinical Care | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | baseline | 3.06 score on a scale | Standard Deviation 1.25 |
| Usual Clinical Care | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | 6 months | 3.29 score on a scale | Standard Deviation 1.31 |
| Usual Clinical Care | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | 12 months | 3.28 score on a scale | Standard Deviation 1.27 |
Secondary
Home Blood Pressure Monitoring Frequency
Self-report of home blood pressure monitoring frequency measured at baseline, 6 months, and 12 months.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | Home Blood Pressure Monitoring Frequency | Baseline | Not on a regular basis | 109 Participants |
| Intervention | Home Blood Pressure Monitoring Frequency | 6 months | At least once a week | 64 Participants |
| Intervention | Home Blood Pressure Monitoring Frequency | Baseline | At least once a day | 7 Participants |
| Intervention | Home Blood Pressure Monitoring Frequency | 6 months | At least once a day | 13 Participants |
| Intervention | Home Blood Pressure Monitoring Frequency | Baseline | At least once per month | 23 Participants |
| Intervention | Home Blood Pressure Monitoring Frequency | 12 months | Not on a regular basis | 32 Participants |
| Intervention | Home Blood Pressure Monitoring Frequency | 6 months | Not on a regular basis | 14 Participants |
| Intervention | Home Blood Pressure Monitoring Frequency | 12 months | At least once per month | 20 Participants |
| Intervention | Home Blood Pressure Monitoring Frequency | Baseline | At least once a week | 13 Participants |
| Intervention | Home Blood Pressure Monitoring Frequency | 12 months | At least once a week | 30 Participants |
| Intervention | Home Blood Pressure Monitoring Frequency | 6 months | At least once per month | 9 Participants |
| Intervention | Home Blood Pressure Monitoring Frequency | 12 months | At least once a day | 4 Participants |
| Usual Clinical Care | Home Blood Pressure Monitoring Frequency | 12 months | At least once a day | 4 Participants |
| Usual Clinical Care | Home Blood Pressure Monitoring Frequency | Baseline | Not on a regular basis | 118 Participants |
| Usual Clinical Care | Home Blood Pressure Monitoring Frequency | Baseline | At least once per month | 20 Participants |
| Usual Clinical Care | Home Blood Pressure Monitoring Frequency | Baseline | At least once a week | 17 Participants |
| Usual Clinical Care | Home Blood Pressure Monitoring Frequency | Baseline | At least once a day | 4 Participants |
| Usual Clinical Care | Home Blood Pressure Monitoring Frequency | 6 months | Not on a regular basis | 67 Participants |
| Usual Clinical Care | Home Blood Pressure Monitoring Frequency | 6 months | At least once per month | 22 Participants |
| Usual Clinical Care | Home Blood Pressure Monitoring Frequency | 6 months | At least once a week | 10 Participants |
| Usual Clinical Care | Home Blood Pressure Monitoring Frequency | 6 months | At least once a day | 5 Participants |
| Usual Clinical Care | Home Blood Pressure Monitoring Frequency | 12 months | Not on a regular basis | 67 Participants |
| Usual Clinical Care | Home Blood Pressure Monitoring Frequency | 12 months | At least once per month | 11 Participants |
| Usual Clinical Care | Home Blood Pressure Monitoring Frequency | 12 months | At least once a week | 8 Participants |
Secondary
Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
Mean number of combined fruit and vegetable servings measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in cups equivalent.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | baseline | 2.34 cups per day | Standard Deviation 2.02 |
| Intervention | Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 6 months | 2.43 cups per day | Standard Deviation 1.75 |
| Intervention | Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 12 months | 2.50 cups per day | Standard Deviation 1.92 |
| Usual Clinical Care | Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | baseline | 2.50 cups per day | Standard Deviation 1.98 |
| Usual Clinical Care | Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 6 months | 2.57 cups per day | Standard Deviation 1.89 |
| Usual Clinical Care | Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 12 months | 2.55 cups per day | Standard Deviation 1.88 |
Secondary
Number of Participants That Achieve Hypertension Control at 6 Months
Hypertension Control: Percentage of participants that achieve hypertension control at 6 months. Hypertension control will be defined using ambulatory blood pressures as the gold standard (\<130/80 mmHg); otherwise a clinic blood pressure of \<140/90 mmHg will be used.
Time frame: up to 6 months
Population: participants lost to follow up, withdrew, and/or removed from study per physician, 2 participants in the Usual clinical care arm did not wear their cuff long enough to get adequate readings for AMBP
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants That Achieve Hypertension Control at 6 Months | 24-hour Ambulatory Blood Pressure | 20 Participants |
| Intervention | Number of Participants That Achieve Hypertension Control at 6 Months | Clinic Measured Blood Pressure | 60 Participants |
| Usual Clinical Care | Number of Participants That Achieve Hypertension Control at 6 Months | 24-hour Ambulatory Blood Pressure | 21 Participants |
| Usual Clinical Care | Number of Participants That Achieve Hypertension Control at 6 Months | Clinic Measured Blood Pressure | 60 Participants |
Secondary
Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
Ounces of whole grain measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | baseline | 0.61 ounces per day | Standard Deviation 1.05 |
| Intervention | Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 6 months | 0.88 ounces per day | Standard Deviation 1.49 |
| Intervention | Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 12 months | 0.82 ounces per day | Standard Deviation 1.25 |
| Usual Clinical Care | Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | baseline | 0.85 ounces per day | Standard Deviation 1.41 |
| Usual Clinical Care | Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 6 months | 1.12 ounces per day | Standard Deviation 1.62 |
| Usual Clinical Care | Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 12 months | 1.14 ounces per day | Standard Deviation 2.24 |
Secondary
Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet
Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet | baseline | 4.63 score on a scale | Standard Deviation 1.6 |
| Intervention | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet | 6 months | 5.35 score on a scale | Standard Deviation 1.41 |
| Intervention | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet | 12 months | 5.06 score on a scale | Standard Deviation 1.52 |
| Usual Clinical Care | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet | 12 months | 5.22 score on a scale | Standard Deviation 1.4 |
| Usual Clinical Care | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet | baseline | 4.93 score on a scale | Standard Deviation 1.58 |
| Usual Clinical Care | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet | 6 months | 5.17 score on a scale | Standard Deviation 1.48 |
Secondary
Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise
Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise | baseline | 4.72 score on a scale | Standard Deviation 1.65 |
| Intervention | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise | 6 months | 5.31 score on a scale | Standard Deviation 1.38 |
| Intervention | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise | 12 months | 5.11 score on a scale | Standard Deviation 1.57 |
| Usual Clinical Care | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise | baseline | 5.00 score on a scale | Standard Deviation 1.53 |
| Usual Clinical Care | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise | 6 months | 5.17 score on a scale | Standard Deviation 1.5 |
| Usual Clinical Care | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise | 12 months | 5.31 score on a scale | Standard Deviation 1.4 |
Secondary
Perceived Competence as Assessed by the Perceived Competence Scale for Diet
Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Perceived Competence as Assessed by the Perceived Competence Scale for Diet | Baseline | 4.54 score on a scale | Standard Deviation 1.34 |
| Intervention | Perceived Competence as Assessed by the Perceived Competence Scale for Diet | 6 months | 5.04 score on a scale | Standard Deviation 1.24 |
| Intervention | Perceived Competence as Assessed by the Perceived Competence Scale for Diet | 12 months | 4.71 score on a scale | Standard Deviation 1.25 |
| Usual Clinical Care | Perceived Competence as Assessed by the Perceived Competence Scale for Diet | Baseline | 4.56 score on a scale | Standard Deviation 1.3 |
| Usual Clinical Care | Perceived Competence as Assessed by the Perceived Competence Scale for Diet | 6 months | 4.63 score on a scale | Standard Deviation 1.43 |
| Usual Clinical Care | Perceived Competence as Assessed by the Perceived Competence Scale for Diet | 12 months | 4.70 score on a scale | Standard Deviation 1.3 |
Secondary
Perceived Competence as Assessed by the Perceived Competence Scale for Exercise
Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Perceived Competence as Assessed by the Perceived Competence Scale for Exercise | Baseline | 4.83 score on a scale | Standard Deviation 1.45 |
| Intervention | Perceived Competence as Assessed by the Perceived Competence Scale for Exercise | 6 months | 5.28 score on a scale | Standard Deviation 1.37 |
| Intervention | Perceived Competence as Assessed by the Perceived Competence Scale for Exercise | 12 months | 4.98 score on a scale | Standard Deviation 1.47 |
| Usual Clinical Care | Perceived Competence as Assessed by the Perceived Competence Scale for Exercise | Baseline | 5.03 score on a scale | Standard Deviation 1.46 |
| Usual Clinical Care | Perceived Competence as Assessed by the Perceived Competence Scale for Exercise | 6 months | 5.01 score on a scale | Standard Deviation 1.54 |
| Usual Clinical Care | Perceived Competence as Assessed by the Perceived Competence Scale for Exercise | 12 months | 4.89 score on a scale | Standard Deviation 1.49 |
Secondary
Physical Activity as Assessed by the Godin Physical Activity Questionnaire
Mean weekly amounts of physical activity as assessed by the Godin Physical Activity Questionnaire. The Godin Physical Activity Questionnaire measures a person's strenuous, moderate, and light physical activity in a week. Scoring is calculated as follows (units are times per week that the participant engaged in any of the 3 classifications of activity longer than 15 minutes during their free time): * 9 x strenous units reported + 5 x moderate units reported + 3 x light units reported = score A minimum score of 0 indicates no activity, a score of less than 14 is interpreted as insufficiently active or sedentary, a score between 14 and 23 is interpreted to be moderately active, and a score of 24 and higher is interpreted to be active, a theoretical maximum does not exist.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Physical Activity as Assessed by the Godin Physical Activity Questionnaire | baseline | 38.24 score on a scale | Standard Deviation 31.51 |
| Intervention | Physical Activity as Assessed by the Godin Physical Activity Questionnaire | 6 months | 54.47 score on a scale | Standard Deviation 61.99 |
| Intervention | Physical Activity as Assessed by the Godin Physical Activity Questionnaire | 12 months | 46.67 score on a scale | Standard Deviation 46.1 |
| Usual Clinical Care | Physical Activity as Assessed by the Godin Physical Activity Questionnaire | baseline | 37.24 score on a scale | Standard Deviation 26.99 |
| Usual Clinical Care | Physical Activity as Assessed by the Godin Physical Activity Questionnaire | 6 months | 40.69 score on a scale | Standard Deviation 31.8 |
| Usual Clinical Care | Physical Activity as Assessed by the Godin Physical Activity Questionnaire | 12 months | 39.22 score on a scale | Standard Deviation 25.22 |
Secondary
Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
Saturated fat measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in percent kilocalories
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | baseline | 11.91 percent kilocalories | Standard Deviation 4.19 |
| Intervention | Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 6 months | 12.97 percent kilocalories | Standard Deviation 4.62 |
| Intervention | Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 12 months | 12.03 percent kilocalories | Standard Deviation 4.72 |
| Usual Clinical Care | Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | baseline | 12.54 percent kilocalories | Standard Deviation 4.32 |
| Usual Clinical Care | Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 6 months | 13.12 percent kilocalories | Standard Deviation 6.56 |
| Usual Clinical Care | Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 12 months | 13.46 percent kilocalories | Standard Deviation 4.52 |
Secondary
Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
Mean daily sodium intake (milligrams/day) at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | baseline | 3512.82 milligrams per day | Standard Deviation 1765.59 |
| Intervention | Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 6 months | 3354.72 milligrams per day | Standard Deviation 1365.75 |
| Intervention | Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 12 months | 3682.94 milligrams per day | Standard Deviation 1874.53 |
| Usual Clinical Care | Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | baseline | 3672.81 milligrams per day | Standard Deviation 1812.82 |
| Usual Clinical Care | Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 6 months | 3968.20 milligrams per day | Standard Deviation 1725.17 |
| Usual Clinical Care | Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | 12 months | 4213.67 milligrams per day | Standard Deviation 1972.37 |
Secondary
Standing Weight (kg)
Weight (kg) measured at baseline, 6 months, and 12 months.
Time frame: baseline, 6 month, and 12 month follow-up
Population: participants lost to follow up, withdrew, and/or removed from study per physician
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Standing Weight (kg) | 12 months | 97.91 kilograms | Standard Deviation 26.07 |
| Intervention | Standing Weight (kg) | 6 months | 98.54 kilograms | Standard Deviation 26.19 |
| Intervention | Standing Weight (kg) | baseline | 102.86 kilograms | Standard Deviation 28.64 |
| Usual Clinical Care | Standing Weight (kg) | 6 months | 103.80 kilograms | Standard Deviation 25.34 |
| Usual Clinical Care | Standing Weight (kg) | 12 months | 103.45 kilograms | Standard Deviation 25.49 |
| Usual Clinical Care | Standing Weight (kg) | baseline | 102.93 kilograms | Standard Deviation 27.3 |
Other Pre-specified
Adverse Events
Number and type of adverse events
Time frame: Through study completion, an average of 5 years
Other Pre-specified
Health Coach Fidelity to the Study Intervention
Evaluation of health coach fidelity to administering the motivational interviewing intervention per protocol will be assessed every 2 months using a modified Behavior Change Counseling Index
Time frame: through completion of administering the study intervention, an average of 4 years
Other Pre-specified
Serious Adverse Events
Number and type of serious adverse events
Time frame: Through study completion, an average of 5 years
Other Pre-specified
Withdrawal
Subject Withdrawal Rate
Time frame: Through study completion, an average of 5 years