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| ID | Type | Description | Link |
|---|---|---|---|
| 9050 | Other Grant/Funding Number | VA CSR&D Merit |
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Tens of thousands of Veterans have heart failure with preserved ejection fraction (HFpEF), and suffer poor quality of life, frequent hospitalizations, and high death rates. Older Veterans and those with high blood pressure, obesity, and the metabolic syndrome (abnormal cholesterol and resistance to insulin's effects) are particularly at risk for HFpEF. However, it is not clear why only some Veterans in this risk group eventually develop HFpEF. Extensive information from experimental animal models and some human studies suggests that dietary patterns in vulnerable 'salt-sensitive' people could contribute to the risk for HFpEF. Reducing salt intake and increasing overall dietary quality in at-risk Veterans could prevent heart and blood vessel damage that ultimately leads to HFpEF. Reducing the development of HFpEF, which currently has no definitive treatment, is highly relevant to the VA's mission to emphasize prevention of disease and population health.
COVID-19 in-person visit hold has been removed- screening and actively enrolling. We are not currently performing sublingual darkfield microscopy because of the need for close face-to-face contact with an open-mouthed patient for several minutes in the setting of COVID-19 pandemic.
Patients with heart failure (HF) account for over 1,200,000 VA outpatient visits per year, and HF remains the most common cause for hospital admission in the VA. Approximately 1/3 of Veterans with HF have 'preserved' ejection fraction (HFpEF), or relatively normal contractile function of the heart; such patients suffer functional decline and poor quality of life, and half die within 5 years after diagnosis. Risk factors for developing HFpEF are more common in Veterans than the general population, and the burden of HFpEF to the VA system will rise in the years ahead as these Veterans age. Preventive efforts are critical, but are hampered by gaps in knowledge related to HFpEF pathophysiology. The long term goal of this proposal is to prevent the onset of HFpEF in at-risk Veterans. Hypertension (HTN) confers the highest population-attributable risk for HFpEF, particularly when accompanied by the metabolic syndrome, a constellation of obesity, insulin resistance, and dyslipidemia. Animal models of HTN and metabolic syndrome develop HFpEF due to microvascular oxidative stress and inflammation induced by high sodium intake. Recent data from cardiac biopsies confirm similar mechanisms in human HFpEF. Dietary sodium restriction is widely recommended to prevent HTN-associated heart disease in humans, but this advice is now controversial. Few studies have examined how individual differences in response to sodium intake affect risk. "Salt-sensitive" persons have blood pressure (BP) that changes in parallel with sodium intake, and commonly develop cardiovascular abnormalities associated with HFpEF. The overall objective of this proposal is to evaluate salt-sensitivity as a novel, diet-responsive risk factor for incident HFpEF in Veterans with HTN and metabolic syndrome. The central hypothesis is that the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating pattern will improve cardiovascular functional and structural risk factors for HFpEF in Veterans with the salt-sensitive phenotype. Guided by findings in experimental models, cohort studies, and strong preliminary evidence from the investigators' research group, this hypothesis will be tested in a two-phase study and by pursuing three specific aims: 1) Determine effects of DASH/SRD on functional and structural cardiovascular HFpEF risk factors in salt-sensitive vs. salt-resistant Veterans, 2) measure the effect of an electronically-delivered tailored-messaging intervention on DASH/SRD adherence, and 3) determine effects of DASH/SRD intervention and adoption on microvascular function and assess the endothelial glycocalyx as a biomarker of cardiovascular response to DASH/SRD. Phase 1 of the study is a sequential comparison of DASH/SRD vs. control diet for two weeks each, and Phase 2 a 6-month extension to promote DASH/SRD adherence. The salt-sensitive phenotype will be defined by between-diet changes in 24-hour mean BP during Phase 1. In Phase 2, the efficacy of motivational interviewing-based counseling and the Women's and Men's Hypertension Experiences and Emerging Lifestyles Intervention (WHEELS-I), a tailored messaging program, to sustain DASH/SRD adherence, will be compared. Echocardiography and arterial tonometry will be used to assess HFpEF-related cardiovascular parameters during short- and longer-term dietary modification and their interaction with salt-sensitivity. In vivo microscopy and novel blood testing will assess microvascular function and the integrity of the endothelial glycocalyx, a blood vessel lining that is sodium-responsive and may mediate the adverse effects of salt-sensitivity. This proposal is innovative because it represents the first study to examine salt-sensitivity as a factor promoting HFpEF in Veterans with HTN and metabolic syndrome, the highest risk group for incident HFpEF. Moreover, it aims to link microvascular dysfunction, an important pathway in human HFpEF, with endothelial glycocalyx damage, a potential biomarker for sodium-mediated vascular risk. The proposed research is significant because it will vertically advance the investigators' understanding of how dietary factors contribute to the pathophysiology of HFpEF, a major and growing health threat to Veterans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interviewing + WHEELS-I | Experimental | In addition to motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan., participants in this arm will also receive an electronically-delivered tailored messaging intervention called Women's and Men's Hypertension Experiences and Emerging Lifestyle Intervention (WHEELS-I). Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals. |
|
| Motivational Interviewing | Active Comparator | Participants in this arm will receive motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan. Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Performance of WHEELS-I in promoting DASH/SRD adoption | Behavioral | All participants will receive motivational interviewing (MI) based counseling. Participants in the MI + WHEELS-I arm will also receive the WHEELS-I electronically-delivered tailored messaging. |
| Measure | Description | Time Frame |
|---|---|---|
| Carotid-femoral Pulse Wave Velocity | Phase 1 primary hypothesis: greater reduction in carotid-femoral pulse wave velocity with DASH diet in individuals with salt-sensitive blood pressure Change in velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness | Phase 1 of study, change between week 2 and week 4 |
| Left Ventricular Mass Index | Left ventricular mass indexed to body surface area. Larger/greater left ventricular mass index is associated with increased long-term risk of cardiovascular events, including the development of heart failure. Normal values for men are 49-115 g/m² and for women 43-95 g/m² | Phase 2 of study, change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Global Longitudinal Left Ventricular Strain | Global longitudinal left ventricular strain (GLS), a sensitive measure of ventricular systolic function GLS is calculated by dividing the reduction in length of a myocardial (heart) segment from the end of diastole (maximum relaxation) to the end of systole (maximum contraction) by the segment's original length at end-diastole (i.e. change in length/original length). GLS is averaged across six myocardial segments, is expressed in a percentage, and is negative by convention since cardiac segment length decreases during systole. The more negative/greater magnitude, the better the GLS. Normal GLS is -18% to -22%. Low GLS is associated with long-term increased risk of cardiovascular events, including the development of heart failure. |
| Measure | Description | Time Frame |
|---|---|---|
| Salt-sensitivity Phenotype | Salt-sensitive blood pressure means that blood pressure changes more than 'normal' when dietary sodium intake changes, i.e. increases or decreases in parallel with sodium intake. Having a salt-sensitive blood pressure pattern is an independent long-term risk factor for cardiovascular events. Variable testing approaches, blood pressure thresholds, and methods of blood pressure measurement have been proposed in the literature to define blood pressure salt-sensitivity. In this study, we report "salt-sensitive" vs. "non salt-sensitive" as a binary variable. Change in 24-hour mean blood pressure of >= 4 mmHg between the ad-lib and home-delivered meal periods of Phase 1 defines the salt-sensitive blood pressure phenotype |
Inclusion Criteria:
Veterans aged 45 years with HTN
and metabolic syndrome
Participants must also be willing to participate in the WHEELS-I program by using a smartphone application or email
Exclusion Criteria:
On-treatment systolic BP of >160 mmHg at screening visit
previous history of HF
left ventricular ejection fraction <50%
moderate or severe valvular heart disease
myocardial infarction or stroke within the prior 6 months
chronic kidney disease with estimated glomerular filtration rate <45 ml/min/ 1.73m2
unoperated aortic aneurysm for which surgery is indicated, prior hyperkalemia requiring urgent treatment
hemoglobin <9 gm/dL
investigator-determined factors: severe pulmonary disease, e.g.:
hepatic disease, e.g.:
severely uncontrolled diabetes (hemoglobin A1c >10%)
active cancer other than non-melanoma skin or low-risk prostate cancer
other comorbidity with expected survival <12 months
active alcohol/illicit substance abuse
and/or a history of persistent nonadherence to treatment
Veterans involved in another study (unless it is survey-only and the other investigator will allow us to invite the person in a survey-only study to consider our study)
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| Name | Affiliation | Role |
|---|---|---|
| Scott L. Hummel, MD | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105-2303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41747920 | Derived | Atluri N, Herty L, Runge C, Wells J, Scisney-Matlock M, Hummel SL. Remote dietitian counseling with short-term meal delivery improves DASH diet adherence and lowers blood pressure in veterans with hypertension and obesity. Am Heart J. 2026 Jul;297:107386. doi: 10.1016/j.ahj.2026.107386. Epub 2026 Feb 24. |
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Phase 1:
Screening visit: Follow baseline diet for 2 weeks Excluded if patient couldn't wean from renin-angiotensin-aldosterone system (RAAS) inhibitors and diuretics without complications
2-week visit: follow DASH-SRD diet for 2 weeks
4-week visit: randomized into Arm 1 or 2 and begin phase II of study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: 2-week Diet As Usual Then 2 Weeks of DASH/SRD Diet | Consented participants will have clinic BP measured at the screening visit and will enter a two-week usual diet period, during which antihypertensive medications, with the exception of calcium channel blockers, will be weaned off. During this time period, the participant will consume their usual diet. Following the usual diet period and the week 2 visit, participants will consume the DASH/SRD diet for 14 days each. |
| FG001 | Motivational Interviewing + WHEELS-I | In addition to motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan., participants in this arm will also receive an electronically-delivered tailored messaging intervention called Women's and Men's Hypertension Experiences and Emerging Lifestyle Intervention (WHEELS-I). Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals. Performance of WHEELS-I in promoting DASH/SRD adoption: Participants will receive the WHEELS-I electronically-delivered tailored messaging intervention in addition to motivational interviewing-based counseling. |
| FG002 | Motivational Interviewing | Participants in this arm will receive motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan. Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 - 4 Weeks |
|
| ||||||||||||||||||
| Phase 2 - 6 Months |
|
The population for baseline analysis includes all 71 participants who started in Phase 1, which includes the 66 participants who continued into the randomization phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: 2-week Diet As Usual Then 2 Weeks of DASH/SRD Diet | This arm includes all participants who started Phase 1 of the study. Phase 1 took place prior to randomization into either the Motivational Interviewing or Motivational Interviewing + WHEELS-I arm. |
| BG001 | Motivational Interviewing + WHEELS-I |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data collected from Phase 1 and Phase 2 are reported in separate Rows |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Carotid-femoral Pulse Wave Velocity | Phase 1 primary hypothesis: greater reduction in carotid-femoral pulse wave velocity with DASH diet in individuals with salt-sensitive blood pressure Change in velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness | Posted | Mean | Standard Deviation | m/s | Phase 1 of study, change between week 2 and week 4 |
|
Baseline to end of study, an average of 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motivational Interviewing + WHEELS-I | In addition to motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan, participants in this arm will also receive an electronically-delivered tailored messaging intervention called Women's and Men's Hypertension Experiences and Emerging Lifestyle Intervention (WHEELS-I). Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment | Participant hospitalization and received new diagnosis of atrial fibrillation. Started on new medication and follow-up with cardiologist. |
Not provided
recruitment initially delayed 1 yr due to VA privacy/information security review for app
Due to COVID-19:
no sublingual darkfield microscopy performed
lost 1.5 yrs recruitment time, had to decrease in-person visits
Related to study diet:
Meal company changed meal offerings and no longer offered high-sodium option
Due to 3) and 4) above: changed protocol to 2 weeks ad-lib diet then 2 weeks low-sodium DASH diet Due to 1) and 3) above: unable to recruit full intended cohort
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Hummel | VA Ann Arbor Health System | 734-845-5283 | scott.hummel@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2022 | May 30, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2025 | May 31, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2022 | Jul 22, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009765 | Obesity |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D017322 | Clinical Trials, Phase II as Topic |
| ID | Term |
|---|---|
| D002986 | Clinical Trials as Topic |
| D000068456 | Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
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Phase 1 of study: sequential design, 14 days each of usual diet followed by 14 days of sodium-restricted DASH diet Phase 2 of study: randomized assignment, 6 months of motivational interviewing vs. motivational interviewing plus mobile application-based promotion of dietary adherence
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|
| Phase 1 of study, change between week 2 to week 4 |
| Carotid-femoral Pulse Wave Velocity | Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness | Phase 2 of study, change from baseline to 6 months |
| Phase 1 of study, change between week 2 and week 4 |
| 24-hour Urinary Sodium Excretion | Measure of daily dietary sodium intake | Phase 2 of study, change from baseline to 6 months |
| Sodium-restricted DASH Diet Adherence by Food Frequency Questionnaire (FFQ) | Sodium-restricted DASH diet score on FFQ, measured by quintiles of intake in 8 dietary domains as compared with age- and sex-matched norms from NHANES national US survey data. Score ranges 8-40 points, with higher scores indicating greater adherence | Phase 2 of study, change from baseline to 6 months |
| Sodium-restricted DASH Diet Adherence | Analysis of 3-day food diaries by a Registered Dietitian, utilizing the Nutrition Data System for Research. DASH diet adherence score based on proportion of recommended daily intake in 9 domains, score ranges 0-9 points with higher scores indicating greater adherence | Phase 2 of study, change from baseline to 6 months |
| Clinic Systolic Blood Pressure | Change in systolic blood pressure obtained in clinic with automated brachial cuff | Phase 2 of study, change from baseline to 6 months |
| Clinic Diastolic Blood Pressure | Phase 2 of study, change from baseline to 6 months |
| Triglycerides | Serum triglyceride changes during dietary intervention | Phase 2 of study, change from baseline to 6 months |
| Urine Sodium and Potassium Ratios | Unitless ratio of urine sodium (in mmol) divided by urine potassium (in mmol), measured from spot samples taken from 24-hour urine samples. | Phase 2 of study, change from baseline to 6 months |
| NOT COMPLETED |
|
|
In addition to motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan., participants in this arm will also receive an electronically-delivered tailored messaging intervention called Women's and Men's Hypertension Experiences and Emerging Lifestyle Intervention (WHEELS-I). Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals. |
| BG002 | Motivational Interviewing | Participants in this arm will receive motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan. Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Data collected from Phase 1 and Phase 2 are reported in separate Rows | Data collected from Phase 1 and Phase 2 are reported in separate Rows | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Data collected from Phase 1 and Phase 2 are reported in separate Rows | Count of Participants | Participants |
|
| Race (NIH/OMB) | Data collected from Phase 1 and Phase 2 are reported in separate Rows | Count of Participants | Participants |
|
| BMI | Data collected from Phase 1 and Phase 2 are reported in separate Rows | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference | Data collected from Phase 1 and Phase 2 are reported in separate Rows | Mean | Standard Deviation | cm |
|
| Hip Circumference | Data collected from Phase 1 and Phase 2 are reported in separate Rows | Mean | Standard Deviation | cm |
|
| Systolic Blood Pressure | Data collected from Phase 1 and Phase 2 are reported in separate Rows | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Data collected from Phase 1 and Phase 2 are reported in separate Rows | Mean | Standard Deviation | mmHg |
|
| Triglycerides | Data collected from Phase 1 and Phase 2 are reported in separate Rows | Mean | Standard Deviation | mg/dL |
|
| HDL Cholesterol | Data collected from Phase 1 and Phase 2 are reported in separate Rows | Mean | Standard Deviation | mg/dL |
|
| Hemoglobin A1c | Data collected from Phase 1 and Phase 2 are reported in separate Rows | Mean | Standard Deviation | % |
|
|
|
|
| Primary | Left Ventricular Mass Index | Left ventricular mass indexed to body surface area. Larger/greater left ventricular mass index is associated with increased long-term risk of cardiovascular events, including the development of heart failure. Normal values for men are 49-115 g/m² and for women 43-95 g/m² | Posted | Mean | Standard Deviation | g/m2 | Phase 2 of study, change from baseline to 6 months |
|
|
|
|
| Secondary | Global Longitudinal Left Ventricular Strain | Global longitudinal left ventricular strain (GLS), a sensitive measure of ventricular systolic function GLS is calculated by dividing the reduction in length of a myocardial (heart) segment from the end of diastole (maximum relaxation) to the end of systole (maximum contraction) by the segment's original length at end-diastole (i.e. change in length/original length). GLS is averaged across six myocardial segments, is expressed in a percentage, and is negative by convention since cardiac segment length decreases during systole. The more negative/greater magnitude, the better the GLS. Normal GLS is -18% to -22%. Low GLS is associated with long-term increased risk of cardiovascular events, including the development of heart failure. | Posted | Mean | Standard Deviation | ratio | Phase 1 of study, change between week 2 to week 4 |
|
|
|
|
| Secondary | Carotid-femoral Pulse Wave Velocity | Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness | Posted | Mean | Standard Deviation | m/s | Phase 2 of study, change from baseline to 6 months |
|
|
|
|
| Other Pre-specified | Salt-sensitivity Phenotype | Salt-sensitive blood pressure means that blood pressure changes more than 'normal' when dietary sodium intake changes, i.e. increases or decreases in parallel with sodium intake. Having a salt-sensitive blood pressure pattern is an independent long-term risk factor for cardiovascular events. Variable testing approaches, blood pressure thresholds, and methods of blood pressure measurement have been proposed in the literature to define blood pressure salt-sensitivity. In this study, we report "salt-sensitive" vs. "non salt-sensitive" as a binary variable. Change in 24-hour mean blood pressure of >= 4 mmHg between the ad-lib and home-delivered meal periods of Phase 1 defines the salt-sensitive blood pressure phenotype | Posted | Count of Participants | Participants | Phase 1 of study, change between week 2 and week 4 |
|
|
|
| Other Pre-specified | 24-hour Urinary Sodium Excretion | Measure of daily dietary sodium intake | Posted | Mean | Standard Deviation | mg/24h | Phase 2 of study, change from baseline to 6 months |
|
|
|
| Other Pre-specified | Sodium-restricted DASH Diet Adherence by Food Frequency Questionnaire (FFQ) | Sodium-restricted DASH diet score on FFQ, measured by quintiles of intake in 8 dietary domains as compared with age- and sex-matched norms from NHANES national US survey data. Score ranges 8-40 points, with higher scores indicating greater adherence | Posted | Mean | Standard Deviation | points | Phase 2 of study, change from baseline to 6 months |
|
|
|
| Other Pre-specified | Sodium-restricted DASH Diet Adherence | Analysis of 3-day food diaries by a Registered Dietitian, utilizing the Nutrition Data System for Research. DASH diet adherence score based on proportion of recommended daily intake in 9 domains, score ranges 0-9 points with higher scores indicating greater adherence | Posted | Mean | Standard Deviation | points | Phase 2 of study, change from baseline to 6 months |
|
|
|
|
| Other Pre-specified | Clinic Systolic Blood Pressure | Change in systolic blood pressure obtained in clinic with automated brachial cuff | Posted | Mean | Standard Deviation | mmHg | Phase 2 of study, change from baseline to 6 months |
|
|
|
|
| Other Pre-specified | Clinic Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | Phase 2 of study, change from baseline to 6 months |
|
|
|
|
| Other Pre-specified | Triglycerides | Serum triglyceride changes during dietary intervention | Posted | Mean | Standard Deviation | mg/dL | Phase 2 of study, change from baseline to 6 months |
|
|
|
|
| Other Pre-specified | Urine Sodium and Potassium Ratios | Unitless ratio of urine sodium (in mmol) divided by urine potassium (in mmol), measured from spot samples taken from 24-hour urine samples. | Posted | Mean | Standard Deviation | ratio | Phase 2 of study, change from baseline to 6 months |
|
|
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| 0 |
| 28 |
| EG001 | Motivational Interviewing | Participants in this arm will receive motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan. Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals. | 0 | 38 | 2 | 38 | 0 | 38 |
|
| Lobectomy | Surgical and medical procedures | Non-systematic Assessment | Lobectomy procedure d/t lung cancer |
|
| Tooth infection | Infections and infestations | Non-systematic Assessment | Hospitalization for infected tooth post extraction |
|
Not provided
Not provided
Not provided
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
| Female |
|
| Male |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
| Hispanic or Latino |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|