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The goal of Nourish is to help adults with high blood pressure enjoy an eating pattern called DASH (Dietary Approaches to Stop Hypertension) to lower blood pressure and improve health. Nourish will use a mobile app and information about DASH to help study participants follow the DASH dietary plan by tracking what they eat and drink every day. The primary outcome of the study is 6-month change in following the DASH eating plan, as measured by 24-hour dietary recalls. The secondary outcome is change in blood pressure. Study participation will last one year.
Over 100 million Americans suffer from high blood pressure and are at increased risk for cardiovascular disease. Evidence supports the DASH (Dietary Approaches to Stop Hypertension) dietary pattern to reduce blood pressure. DASH is rich in fruits and vegetables, legumes, lean protein, and low-fat dairy, and reduced in red meats, sweets and processed foods. The Nourish trial will look at the effect of the intervention on changes in dietary quality and blood pressure among men and women with high blood pressure. Participants who join Nourish will be asked to track what they eat and drink every day through a smartphone app and to participate in online study visits. Some participants will also receive additional support from a registered dietitian. We are doing this study to understand how technology can help adults with high blood pressure follow a heart-healthy eating plan to improve their blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants will track their daily dietary intake for six months using an app and will receive automated feedback daily via text message based on DASH nutrients. Participants in-need of coaching based on their adherence to the key nutrients in the DASH dietary pattern or engagement in the intervention will receive responsive digital coaching from Nourish registered dietitians. |
|
| Control | No Intervention | Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tracking plus coaching | Behavioral | Participants will track their nutrition intake every day for six months using a study app and receive tailored feedback via text message based on their nutritional intake and adherence to the DASH dietary pattern. If necessary, they will receive responsive coaching from a Nourish registered dietitian in order to increase adherence to the DASH dietary pattern and their engagement with the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score | Participants entered their dietary intake online via the National Cancer Institute's Automated Self-Administered 24-hour (ASA24) Dietary Assessment tool to record 2 separate 24-hour dietary recalls (1 weekday and 1 weekend day). DASH dietary nutrients are then converted into a score using the method described in Mellen et al (2008). Scores ranged from 0 to 9 where a higher score indicates better adherence to the DASH dietary pattern. Change in DASH score = 6-month DASH score - Baseline DASH score. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | Systolic blood pressure measured in millimeters of mercury (mmHg) using the upper arm three times at 1-minute intervals after 5 minutes of quiet sitting. Blood pressure was measured 3 times at 1 minute intervals. The final 2 measurements were averaged together for analysis. Change in systolic blood pressure = 6-month systolic blood pressure - Baseline systolic blood pressure. |
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Inclusion Criteria:
Exclusion Criteria:
To learn more about the study and to see if eligible to participate, visit www.nourishstudy.org
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| Name | Affiliation | Role |
|---|---|---|
| Gary G. Bennett, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27708 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention - Tracking Plus Coaching | Participants will track their daily dietary intake for six months using an app and will receive automated feedback daily via text message based on DASH nutrients. Participants in-need of coaching based on their adherence to the key nutrients in the DASH dietary pattern or engagement in the intervention will receive responsive digital coaching from Nourish registered dietitians. Tracking plus coaching: Participants will track their nutrition intake every day for six months using a study app and receive tailored feedback via text message based on their nutritional intake and adherence to the DASH dietary pattern. If necessary, they will receive responsive coaching from a Nourish registered dietitian in order to increase adherence to the DASH dietary pattern and their engagement with the intervention. |
| FG001 | Attention Control | Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention - Tracking Plus Coaching | Participants will track their daily dietary intake for six months using an app and will receive automated feedback daily via text message based on DASH nutrients. Participants in-need of coaching based on their adherence to the key nutrients in the DASH dietary pattern or engagement in the intervention will receive responsive digital coaching from Nourish registered dietitians. Tracking plus coaching: Participants will track their nutrition intake every day for six months using a study app and receive tailored feedback via text message based on their nutritional intake and adherence to the DASH dietary pattern. If necessary, they will receive responsive coaching from a Nourish registered dietitian in order to increase adherence to the DASH dietary pattern and their engagement with the intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score | Participants entered their dietary intake online via the National Cancer Institute's Automated Self-Administered 24-hour (ASA24) Dietary Assessment tool to record 2 separate 24-hour dietary recalls (1 weekday and 1 weekend day). DASH dietary nutrients are then converted into a score using the method described in Mellen et al (2008). Scores ranged from 0 to 9 where a higher score indicates better adherence to the DASH dietary pattern. Change in DASH score = 6-month DASH score - Baseline DASH score. | Participants who completed the baseline and 6-month dietary recalls. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
|
Randomization through 12 months (final endpoint of trial)
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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 | Intervention - Tracking Plus Coaching | Participants will track their daily dietary intake for six months using an app and will receive automated feedback daily via text message based on DASH nutrients. Participants in-need of coaching based on their adherence to the key nutrients in the DASH dietary pattern or engagement in the intervention will receive responsive digital coaching from Nourish registered dietitians. Tracking plus coaching: Participants will track their nutrition intake every day for six months using a study app and receive tailored feedback via text message based on their nutritional intake and adherence to the DASH dietary pattern. If necessary, they will receive responsive coaching from a Nourish registered dietitian in order to increase adherence to the DASH dietary pattern and their engagement with the intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular issues (pacemaker, MI, afib, etc.) | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Issues with eyes | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary G. Bennett, PhD | Duke University | 919-684-4510 | gary.bennett@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 14, 2024 | Mar 13, 2024 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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|
| Baseline and 6 months |
| Change in Diastolic Blood Pressure | Diastolic blood pressure measured in millimeters of mercury (mmHg) using the upper arm three times at 1-minute intervals after 5 minutes of quiet sitting. Blood pressure was measured 3 times at 1 minute intervals. The final 2 measurements were averaged together for analysis. Change in diastolic blood pressure = 6-month diastolic blood pressure - Baseline diastolic blood pressure. | Baseline and 6 months |
| Did not complete assessment |
|
| Became ineligible |
|
| BG001 | Attention Control | Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Attention Control | Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months. |
|
|
|
| Secondary | Change in Systolic Blood Pressure | Systolic blood pressure measured in millimeters of mercury (mmHg) using the upper arm three times at 1-minute intervals after 5 minutes of quiet sitting. Blood pressure was measured 3 times at 1 minute intervals. The final 2 measurements were averaged together for analysis. Change in systolic blood pressure = 6-month systolic blood pressure - Baseline systolic blood pressure. | Posted | Mean | Standard Deviation | mmHg | Baseline and 6 months |
|
|
|
|
| Secondary | Change in Diastolic Blood Pressure | Diastolic blood pressure measured in millimeters of mercury (mmHg) using the upper arm three times at 1-minute intervals after 5 minutes of quiet sitting. Blood pressure was measured 3 times at 1 minute intervals. The final 2 measurements were averaged together for analysis. Change in diastolic blood pressure = 6-month diastolic blood pressure - Baseline diastolic blood pressure. | Participants who completed the blood pressure assessment protocol. | Posted | Mean | Standard Deviation | mmHg | Baseline and 6 months |
|
|
|
|
| 0 |
| 150 |
| 6 |
| 150 |
| 28 |
| 150 |
| EG001 | Attention Control | Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months. | 0 | 151 | 15 | 151 | 21 | 151 |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| COPD related | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Mental health issues | Psychiatric disorders | Non-systematic Assessment |
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| Broken limbs/accidents | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Arthritis | Immune system disorders | Non-systematic Assessment |
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| Detached retina | Eye disorders | Non-systematic Assessment |
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| Choking | Gastrointestinal disorders | Non-systematic Assessment |
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| Urological issues | Renal and urinary disorders | Non-systematic Assessment |
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| Magnesium deficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Breast reconstructive surgery | Reproductive system and breast disorders | Non-systematic Assessment |
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| Parkinsons | Nervous system disorders | Non-systematic Assessment |
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| Sinus/respiratory issues | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Various medical procedures | Surgical and medical procedures | Non-systematic Assessment |
|
| GI issues | Gastrointestinal disorders | Non-systematic Assessment |
|
| Mental health challenges | Psychiatric disorders | Non-systematic Assessment |
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| Fractured bones/torn ligaments | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Heart rate/BP/ afib | Cardiac disorders | Non-systematic Assessment |
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| Immune-related issues | Immune system disorders | Non-systematic Assessment |
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| Infections from ticks | Infections and infestations | Non-systematic Assessment |
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| Kidney related issues | Renal and urinary disorders | Non-systematic Assessment |
|
| Cancer related issues | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Accidents | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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