Health Behavior, Hypertension
Conditions
Keywords
Blood pressure, Hypertension, DASH, Nutrition, Dietary change, Mobile health, Digital health, E-health
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTracking 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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 80-99 mmHg, whether or not taking blood pressure medications. * BMI ≥ 18.5 kg/m2 * Smartphone with a data plan * Willing to receive daily text messages * Valid email address * Willing and able to participate in online study videoconferencing visits (Zoom) * Lives in the U.S. * Reads and writes in English
Exclusion criteria
* Participating in another related research study * Cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months * Bariatric surgery in the last 12 months or planned during the study period * Active cancer * Recent hospitalization due to psychiatric condition or event * Pregnancy- current or planned during the study period * Documented dementia * Lives with someone else participating in the Nourish study To learn more about the study and to see if eligible to participate, visit www.nourishstudy.org
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score | Baseline and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | Baseline and 6 months | 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. |
| Change in Diastolic Blood Pressure | Baseline and 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 150 |
| Attention Control Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months. | 151 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Became ineligible | 1 | 0 |
| Overall Study | Did not complete assessment | 21 | 12 |
| Overall Study | Lost to Follow-up | 16 | 13 |
| Overall Study | Withdrawal by Subject | 10 | 21 |
Baseline characteristics
| Characteristic | Intervention - Tracking Plus Coaching | Total | Attention Control |
|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 13.1 | 54.4 years STANDARD_DEVIATION 13.4 | 53.4 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 22 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 139 Participants | 279 Participants | 140 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 14 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 100 Participants | 53 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) White | 89 Participants | 172 Participants | 83 Participants |
| Region of Enrollment United States | 150 Participants | 301 Participants | 151 Participants |
| Sex: Female, Male Female | 101 Participants | 196 Participants | 95 Participants |
| Sex: Female, Male Male | 49 Participants | 105 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 151 |
| other Total, other adverse events | 28 / 150 | 21 / 151 |
| serious Total, serious adverse events | 6 / 150 | 15 / 151 |
Outcome results
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.
Time frame: Baseline and 6 months
Population: Participants who completed the baseline and 6-month dietary recalls.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention - Tracking Plus Coaching | Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score | 0.3 score on a scale | Standard Deviation 1.7 |
| Attention Control | Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score | 0.3 score on a scale | Standard Deviation 1.8 |
Comparison: The expected effect size is 0.5. The investigators hypothesize that the intervention will lead to an increase in average DASH score of 2 units. The investigators used a standard deviation for 2 units for both intervention and attention control groups since higher variability may be observed with a bigger sample size than the pilot study.p-value: 0.8995% CI: [-0.44, 0.5]t-test, 2 sided
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.
Time frame: Baseline and 6 months
Population: Participants who completed the blood pressure assessment protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention - Tracking Plus Coaching | Change in Diastolic Blood Pressure | -3.0 mmHg | Standard Deviation 8.6 |
| Attention Control | Change in Diastolic Blood Pressure | -2.1 mmHg | Standard Deviation 7.9 |
Comparison: The expected effect size for change in diastolic blood pressure (DBP) between intervention and control group is 0.75 based on the pilot study. With a 90% power and a type I error rate (alpha) of .01, the investigators can detect the expected effect size with the proposed sample size of 121 per study arm.p-value: 0.3995% CI: [-3.1, 1.2]t-test, 2 sided
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention - Tracking Plus Coaching | Change in Systolic Blood Pressure | -5.5 mmHg | Standard Deviation 13 |
| Attention Control | Change in Systolic Blood Pressure | -3.5 mmHg | Standard Deviation 12.9 |
Comparison: The expected effect size for change in systolic blood pressure (SBP) between intervention and control group is 0.6 based on the pilot study. With a 90% power and a type I error rate (alpha) of .01, the investigators can detect the expected effect size with the proposed sample size of 121 per study arm.p-value: 0.2695% CI: [-5.3, 1.4]t-test, 2 sided