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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
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This study will examine the effects of low sodium meal plan on seated blood pressure in older adults from a community-based, congregate senior living facility.
Hypertension in older adults is a known contributor to both cardiovascular disease and falls. The Centers of Disease Control advocates for low sodium, senior meal plans as a strategy to lower blood pressure (BP). However, sodium is recommended to treat orthostatic hypotension (OH), a risk factor of falls. The long-term effects of low sodium intake on physical function are largely unknown in older adults.
The objective of this proposed pilot study is to determine the feasibility of an individual-level, randomized feeding study that examines the impact of sodium reduction on BP regulation among 40 semi-independent, older adults aged 60 and above.
Primary Aim 1: To determine the effects of a low sodium (<0.9 mg per kcal of energy intake), 2-week meal plan compared with a usual meal plan (average sodium ~2 mg per kcal of energy intake) on seated BP among independently living older adults.
Hypothesis Aim 1: Compared with the usual meal plan, a reduced sodium meal plan will lower seated BP in older adults after 2 weeks.
Feasibility Aim 1: To evaluate the recruitment experience, meal cost, meal delivery logistics, and compliance with and tolerability of the meal plan (urine sodium and palatability questionnaires).
Feasibility Aim 2: To determine effect size (variance) of secondary outcomes: standing BP, OH (standing minus seated BP), orthostatic symptoms, and a timed up and go test (TUG).
Eligible participants will be randomized to low versus usual sodium meal plans for two weeks. Assessments will be made at the in-person baseline visit, one week telephonic interview and 2 week in person follow-up visit.
The primary outcome is seated BP and secondary outcomes include orthostatic hypertension and Timed Up and Go (TUG) tests. Both primary and secondary outcomes will be measured twice: (1) before the study begins (baseline), and (2) after 2 week period. Patient-reported outcomes, dietary compliance, and urine electrolytes will be assessed as well.
Intent-to-treat analysis will be conducted for all endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low sodium diet | Experimental | This group will get a low sodium diet (<0.9 mg per kcal of energy intake). |
|
| Usual sodium diet | Active Comparator | This group will get a usual sodium diet (~2 mg per kcal of energy intake). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention | Other | Intervention include low sodium or usual sodium diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seated Blood Pressure | Average of three seated systolic and diastolic blood pressure readings | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Orthostatic Hypotension | Measured from supine and standing systolic and diastolic blood pressure readings | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Timed up and go Test | Participant will be asked to start from seated position, stand up from the chair, walk 3 meters in a straight line, turn, walk back to the chair and sit down. The investigators will use average of the two trials. | 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shivani Sahni, PhD | Marcus Institute, Hebrew SeniorLife and Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jack Satter House | Revere | Massachusetts | 02151 | United States |
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Of the approximately 285 residents of Jack Satter House, 59 adults expressed interest in participation. We ultimately enrolled 20 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Sodium Diet | This group will get a low sodium diet (<0.9 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet |
| FG001 | Usual Sodium Diet | This group will get a usual sodium diet (~2 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Sodium Diet | This group will get a low sodium diet (<0.9 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet |
| BG001 | Usual Sodium Diet |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Seated Blood Pressure | Average of three seated systolic and diastolic blood pressure readings | Posted | Mean | Standard Deviation | mmHg | 2 weeks |
|
2 weeks
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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 | Low Sodium Diet | This group will get a low sodium diet (<0.9 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High blood glucose in participants with baseline diabetes | Endocrine disorders | Non-systematic Assessment | Self-reported |
Limitations include low powered, which was expected as we fell short of recruitment goals and enrolled adults without elevated blood pressure. Our study lasted a short duration. Effects from sodium on BP may take up to 4 weeks, while effects on physical function may require even more time to occur. Our study included predominantly White obese females which limits generalizability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shivani Sahni, PhD | Marcus Institute, Hebrew SeniorLife | 6179715382 | shivanisahni@hsl.harvard.edu |
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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 | Oct 29, 2019 | Nov 21, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 29, 2019 | Nov 21, 2019 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2019 | Nov 21, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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Participants will be randomized to either a low sodium diet or a usual sodium diet for a period of two weeks.
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Study staff involved in administering the dietary intervention and assessing compliance will be masked to participants' outcome assessments (e.g. BP).
This group will get a usual sodium diet (~2 mg per kcal of energy intake).
Dietary intervention: Intervention include low sodium or usual sodium diet
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Systolic blood pressure, mmHg | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure, mmHg | Mean | Standard Deviation | mmHg |
|
| Hypertension, % | Count of Participants | Participants |
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| Hypertension medication use, % | Count of Participants | Participants |
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| Measured orthostatic hypertension, % | Count of Participants | Participants |
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| BMI, kg/m^2 | Mean | Standard Deviation | kg/m^2 |
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| Montreal Cognitive Assessment score | Scores range from 0-30, with a score of 26 and higher generally considered normal | Mean | Standard Deviation | scores on a scale |
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| Physical activity score | Scores range from 0-42, with higher scores representing higher physical activity | Mean | Standard Deviation | scores on a scale |
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| Timed-up-and-go, sec | Mean | Standard Deviation | seconds |
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| Estimated calorie intake, kcal/d | Mean | Standard Deviation | kcal/day |
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| Units | Counts |
|---|
| Participants |
|
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| Secondary | Orthostatic Hypotension | Measured from supine and standing systolic and diastolic blood pressure readings | Posted | Count of Participants | Participants | 2 weeks |
|
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| Other Pre-specified | Timed up and go Test | Participant will be asked to start from seated position, stand up from the chair, walk 3 meters in a straight line, turn, walk back to the chair and sit down. The investigators will use average of the two trials. | Posted | Mean | Standard Deviation | seconds | 2 weeks |
|
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Usual Sodium Diet | This group will get a usual sodium diet (~2 mg per kcal of energy intake). Dietary intervention: Intervention include low sodium or usual sodium diet | 0 | 9 | 0 | 9 | 2 | 9 |
|
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