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NCT03875768

Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure

Completed NA Results posted Last updated 16 August 2024
What this trial tests

NA trial testing Tracking plus coaching in Hypertension in 301 participants. Completed in 20 March 2023.

Timeline
29 September 2020
Primary endpoint
20 March 2023
20 March 2023

Quick facts

Lead sponsorDuke University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment301
Start date29 September 2020
Primary completion20 March 2023
Estimated completion20 March 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Duke University

Who can join

18 and older, any sex, with Hypertension or Health Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score Primary · 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.

GroupValue95% CI
Intervention - Tracking Plus Coaching0.3± 1.7
Attention Control0.3± 1.8
Change in Systolic Blood Pressure Secondary · 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.

GroupValue95% CI
Intervention - Tracking Plus Coaching-5.5± 13.0
Attention Control-3.5± 12.9
Change in Diastolic Blood Pressure Secondary · 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.

GroupValue95% CI
Intervention - Tracking Plus Coaching-3.0± 8.6
Attention Control-2.1± 7.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Randomization through 12 months (final endpoint of trial). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention - Tracking Plus Coaching
Serious: 6/150 (4%)
Deaths: 0/150
Attention Control
Serious: 15/151 (10%)
Deaths: 0/151

Serious adverse events (12 terms)

ReactionSystemIntervention - Tracking Pl…Attention Control
Broken limbs/accidentsInjury, poisoning and procedural complications
Cardiovascular issues (pacemaker, MI, afib, etc.)Cardiac disorders
CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)
COPD relatedRespiratory, thoracic and mediastinal disorders
Mental health issuesPsychiatric disorders
ArthritisImmune system disorders
Detached retinaEye disorders
ChokingGastrointestinal disorders
Urological issuesRenal and urinary disorders
Magnesium deficiencyMetabolism and nutrition disorders
Breast reconstructive surgeryReproductive system and breast disorders
ParkinsonsNervous system disorders
Other adverse events (12 terms — click to expand)

ReactionSystemIntervention - Tracking Pl…Attention Control
Heart rate/BP/ afibCardiac disorders
Various medical proceduresSurgical and medical procedures
GI issuesGastrointestinal disorders
Sinus/respiratory issuesRespiratory, thoracic and mediastinal disorders
Fractured bones/torn ligamentsMusculoskeletal and connective tissue disorders
Immune-related issuesImmune system disorders
Kidney related issuesRenal and urinary disorders
Cancer related issuesNeoplasms benign, malignant and unspecified (incl cysts and polyps)
AccidentsInjury, poisoning and procedural complications
Issues with eyesEye disorders
Mental health challengesPsychiatric disorders
Infections from ticksInfections and infestations

Most-reported serious reactions: Broken limbs/accidents, Cardiovascular issues (pacemaker, MI, afib, etc.), Cancer, COPD related, Mental health issues, Arthritis, Detached retina, Choking.

Data from ClinicalTrials.gov NCT03875768 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effects of a Digital Intervention to Improve DASH and Blood Pressure Among US Adults.
    Miller HN, Askew S, Berger MB, Kay MC, et al · · 2025 · cited 4× · PMID 39711367 · DOI 10.1161/hypertensionaha.124.23887
  2. Sociodemographic predictors of successful screening and subsequent randomization in a digital health hypertension intervention.
    Miller HN, Askew S, Berger MB, Trefney E, et al · · 2024 · cited 1× · PMID 39360240 · DOI 10.1177/20552076241281216

Verify or expand the search:

Other recruiting trials for Hypertension

Currently open trials in the same condition.

Other Duke University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03875768.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing