Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-04 @ 5:38 PM
Study NCT ID:
NCT03875768
Status:
COMPLETED
Last Update Posted:
2024-08-16
First Post:
2019-03-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gary.bennett@duke.edu', 'phone': '919-684-4510', 'title': 'Gary G. Bennett, PhD', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Randomization through 12 months (final endpoint of trial)', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention - Tracking Plus Coaching', 'description': '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.\n\nTracking 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.', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 28, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Attention Control', 'description': 'Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 21, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Issues with eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus/respiratory issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Various medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mental health challenges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fractured bones/torn ligaments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart rate/BP/ afib', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune-related issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections from ticks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney related issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer related issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Accidents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiovascular issues (pacemaker, MI, afib, etc.)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'COPD related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mental health issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken limbs/accidents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Detached retina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Choking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urological issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Magnesium deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast reconstructive surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Parkinsons', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Tracking Plus Coaching', 'description': '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.\n\nTracking 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.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.50', 'pValueComment': 'The threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.72', 'groupDescription': '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.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Results presented are unadjusted.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the baseline and 6-month dietary recalls.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Tracking Plus Coaching', 'description': '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.\n\nTracking 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.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '12.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '1.4', 'pValueComment': 'The threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '13.0', 'groupDescription': '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.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Results presented are unadjusted.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Tracking Plus Coaching', 'description': '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.\n\nTracking 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.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '7.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '1.2', 'pValueComment': 'The threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '8.3', 'groupDescription': '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.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Results presented are unadjusted.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': '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.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the blood pressure assessment protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention - Tracking Plus Coaching', 'description': '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.\n\nTracking 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.'}, {'id': 'FG001', 'title': 'Attention Control', 'description': 'Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Did not complete assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Became ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention - Tracking Plus Coaching', 'description': '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.\n\nTracking 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.'}, {'id': 'BG001', 'title': 'Attention Control', 'description': 'Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '53.4', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '54.4', 'spread': '13.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-14', 'size': 1507087, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_001.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-03-13T14:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2019-03-13', 'resultsFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-13', 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score', 'timeFrame': 'Baseline and 6 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'Baseline and 6 months', 'description': '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.'}, {'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': 'Baseline and 6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood pressure', 'Hypertension', 'DASH', 'Nutrition', 'Dietary change', 'Mobile health', 'Digital health', 'E-health'], 'conditions': ['Hypertension', 'Health Behavior']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 80-99 mmHg, whether or not taking blood pressure medications.\n* BMI ≥ 18.5 kg/m2\n* Smartphone with a data plan\n* Willing to receive daily text messages\n* Valid email address\n* Willing and able to participate in online study videoconferencing visits (Zoom)\n* Lives in the U.S.\n* Reads and writes in English\n\nExclusion Criteria:\n\n* Participating in another related research study\n* Cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months\n* Bariatric surgery in the last 12 months or planned during the study period\n* Active cancer\n* Recent hospitalization due to psychiatric condition or event\n* Pregnancy- current or planned during the study period\n* Documented dementia\n* Lives with someone else participating in the Nourish study\n\nTo learn more about the study and to see if eligible to participate, visit www.nourishstudy.org'}, 'identificationModule': {'nctId': 'NCT03875768', 'briefTitle': 'Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Using Digital Health to Improve Diet Quality Among Adults at Risk for Cardiovascular Disease', 'orgStudyIdInfo': {'id': 'Pro00101689'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '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.', 'interventionNames': ['Behavioral: Tracking plus coaching']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.'}], 'interventions': [{'name': 'Tracking plus coaching', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Gary G. Bennett, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}