An interventional study of Tracking plus coaching in Hypertension and Health Behavior, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
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.
6,690 studies on the registry are indexed under Hypertension; 966 are open to participants now.
This study's enrollment of 301 is above the median of 90 across 4,996 interventional studies indexed under Hypertension.
Browse Hypertension studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
To learn more about the study and to see if eligible to participate, visit www.nourishstudy.org
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.
Behavioral: Tracking plus coaching
Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.
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.
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.
Time frame: Baseline and 6 months
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.
Time frame: 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.
Time frame: Baseline and 6 months
| Milestone | Intervention - Tracking Plus Coaching | Attention Control |
|---|---|---|
| Started | 150 | 151 |
| Completed | 102 | 105 |
| Not completed | 48 | 46 |
| Withdrew: Lost to follow-up | 16 | 13 |
| Withdrew: Withdrawal by subject | 10 | 21 |
| Withdrew: Did not complete assessment | 21 | 12 |
| Withdrew: Became ineligible | 1 | 0 |
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.
| score on a scale | Intervention - Tracking Plus Coaching | Attention Control |
|---|---|---|
| Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score | 0.3 ± 1.7 | 0.3 ± 1.8 |
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.
| mmHg | Intervention - Tracking Plus Coaching | Attention Control |
|---|---|---|
| Change in Systolic Blood Pressure | -5.5 ± 13.0 | -3.5 ± 12.9 |
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.
| mmHg | Intervention - Tracking Plus Coaching | Attention Control |
|---|---|---|
| Change in Diastolic Blood Pressure | -3.0 ± 8.6 | -2.1 ± 7.9 |
Collected over Randomization through 12 months (final endpoint of trial). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention - Tracking Plus Coaching | 0/150 (0%) | 6/150 (4%) | 28/150 (18.7%) |
| Attention Control | 0/151 (0%) | 15/151 (9.9%) | 21/151 (13.9%) |
| Event | Intervention - Tracking Plus Coaching | Attention Control |
|---|---|---|
| Broken limbs/accidentsInjury, poisoning and procedural complications | 2/150 | 3/151 |
| Cardiovascular issues (pacemaker, MI, afib, etc.)Cardiac disorders | 2/150 | 2/151 |
| CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/150 | 2/151 |
| COPD relatedRespiratory, thoracic and mediastinal disorders | 0/150 | 2/151 |
| Mental health issuesPsychiatric disorders | 1/150 | 0/151 |
| Breast reconstructive surgeryReproductive system and breast disorders | 1/150 | 0/151 |
| ArthritisImmune system disorders | 0/150 | 1/151 |
| Detached retinaEye disorders | 0/150 | 1/151 |
| ChokingGastrointestinal disorders | 0/150 | 1/151 |
| Urological issuesRenal and urinary disorders | 0/150 | 1/151 |
| Event | Intervention - Tracking Plus Coaching | Attention Control |
|---|---|---|
| Heart rate/BP/ afibCardiac disorders | 5/150 | 6/151 |
| GI issuesGastrointestinal disorders | 5/150 | 2/151 |
| Various medical proceduresSurgical and medical procedures | 4/150 | 5/151 |
| Sinus/respiratory issuesRespiratory, thoracic and mediastinal disorders | 3/150 | 1/151 |
| Fractured bones/torn ligamentsMusculoskeletal and connective tissue disorders | 2/150 | 2/151 |
| Immune-related issuesImmune system disorders | 2/150 | 0/151 |
| Kidney related issuesRenal and urinary disorders | 2/150 | 0/151 |
| Cancer related issuesNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/150 | 2/151 |
| AccidentsInjury, poisoning and procedural complications | 0/150 | 2/151 |
| Issues with eyesEye disorders | 1/150 | 0/151 |
| Age, Continuous(years) | Intervention - Tracking Plus Coaching | Attention Control | Total |
|---|---|---|---|
| Mean | 55.4 ± 13.1 | 53.4 ± 13.6 | 54.4 ± 13.4 |
| Sex: Female, Male(Participants) | Intervention - Tracking Plus Coaching | Attention Control | Total |
|---|---|---|---|
| Female | 101 | 95 | 196 |
| Male | 49 | 56 | 105 |
| Ethnicity (NIH/OMB)(Participants) | Intervention - Tracking Plus Coaching | Attention Control | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 11 | 22 |
| Not Hispanic or Latino | 139 | 140 | 279 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention - Tracking Plus Coaching | Attention Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 5 | 9 | 14 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 47 | 53 | 100 |
| White | 89 | 83 | 172 |
| More than one race | 3 | 4 | 7 |
| Unknown or Not Reported | 5 | 2 | 7 |
| Region of Enrollment(Participants) | Intervention - Tracking Plus Coaching | Attention Control | Total |
|---|---|---|---|
| United States | 150 | 151 | 301 |
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