Trial Outcomes & Findings for Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure (NCT NCT03875768)

Last Updated: 2024-08-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

301 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2024-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Attention Control Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.
Overall Study STARTED	150	151
Overall Study COMPLETED	102	105
Overall Study NOT COMPLETED	48	46

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Attention Control Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.
Overall Study Lost to Follow-up	16	13
Overall Study Withdrawal by Subject	10	21
Overall Study Did not complete assessment	21	12
Overall Study Became ineligible	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention - Tracking Plus Coaching n=150 Participants 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.	Attention Control n=151 Participants Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.	Total n=301 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 13.1 • n=5 Participants	53.4 years STANDARD_DEVIATION 13.6 • n=7 Participants	54.4 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	95 Participants n=7 Participants	196 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	56 Participants n=7 Participants	105 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	139 Participants n=5 Participants	140 Participants n=7 Participants	279 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	47 Participants n=5 Participants	53 Participants n=7 Participants	100 Participants n=5 Participants
Race (NIH/OMB) White	89 Participants n=5 Participants	83 Participants n=7 Participants	172 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	150 Participants n=5 Participants	151 Participants n=7 Participants	301 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Participants who completed the baseline and 6-month dietary recalls.

Outcome measures

Outcome measures
Measure	Intervention - Tracking Plus Coaching n=102 Participants 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.	Attention Control n=105 Participants Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.
Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score	0.3 score on a scale Standard Deviation 1.7	0.3 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention - Tracking Plus Coaching n=122 Participants 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.	Attention Control n=113 Participants Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.
Change in Systolic Blood Pressure	-5.5 mmHg Standard Deviation 13.0	-3.5 mmHg Standard Deviation 12.9

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Participants who completed the blood pressure assessment protocol.

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.

Outcome measures

Outcome measures
Measure	Intervention - Tracking Plus Coaching n=122 Participants 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.	Attention Control n=113 Participants Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.
Change in Diastolic Blood Pressure	-3.0 mmHg Standard Deviation 8.6	-2.1 mmHg Standard Deviation 7.9

Adverse Events

Intervention - Tracking Plus Coaching

Serious events: 6 serious events

Other events: 28 other events

Deaths: 0 deaths

Attention Control

Serious events: 15 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention - Tracking Plus Coaching n=150 participants at risk 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.	Attention Control n=151 participants at risk Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.
Cardiac disorders Cardiovascular issues (pacemaker, MI, afib, etc.)	1.3% 2/150 • Randomization through 12 months (final endpoint of trial)	1.3% 2/151 • Randomization through 12 months (final endpoint of trial)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.00% 0/150 • Randomization through 12 months (final endpoint of trial)	1.3% 2/151 • Randomization through 12 months (final endpoint of trial)
Respiratory, thoracic and mediastinal disorders COPD related	0.00% 0/150 • Randomization through 12 months (final endpoint of trial)	1.3% 2/151 • Randomization through 12 months (final endpoint of trial)
Psychiatric disorders Mental health issues	0.67% 1/150 • Randomization through 12 months (final endpoint of trial)	0.00% 0/151 • Randomization through 12 months (final endpoint of trial)
Injury, poisoning and procedural complications Broken limbs/accidents	1.3% 2/150 • Randomization through 12 months (final endpoint of trial)	2.0% 3/151 • Randomization through 12 months (final endpoint of trial)
Immune system disorders Arthritis	0.00% 0/150 • Randomization through 12 months (final endpoint of trial)	0.66% 1/151 • Randomization through 12 months (final endpoint of trial)
Eye disorders Detached retina	0.00% 0/150 • Randomization through 12 months (final endpoint of trial)	0.66% 1/151 • Randomization through 12 months (final endpoint of trial)
Gastrointestinal disorders Choking	0.00% 0/150 • Randomization through 12 months (final endpoint of trial)	0.66% 1/151 • Randomization through 12 months (final endpoint of trial)
Renal and urinary disorders Urological issues	0.00% 0/150 • Randomization through 12 months (final endpoint of trial)	0.66% 1/151 • Randomization through 12 months (final endpoint of trial)
Metabolism and nutrition disorders Magnesium deficiency	0.00% 0/150 • Randomization through 12 months (final endpoint of trial)	0.66% 1/151 • Randomization through 12 months (final endpoint of trial)
Reproductive system and breast disorders Breast reconstructive surgery	0.67% 1/150 • Randomization through 12 months (final endpoint of trial)	0.00% 0/151 • Randomization through 12 months (final endpoint of trial)
Nervous system disorders Parkinsons	0.00% 0/150 • Randomization through 12 months (final endpoint of trial)	0.66% 1/151 • Randomization through 12 months (final endpoint of trial)

Other adverse events

Other adverse events
Measure	Intervention - Tracking Plus Coaching n=150 participants at risk 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.	Attention Control n=151 participants at risk Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.
Eye disorders Issues with eyes	0.67% 1/150 • Randomization through 12 months (final endpoint of trial)	0.00% 0/151 • Randomization through 12 months (final endpoint of trial)
Respiratory, thoracic and mediastinal disorders Sinus/respiratory issues	2.0% 3/150 • Randomization through 12 months (final endpoint of trial)	0.66% 1/151 • Randomization through 12 months (final endpoint of trial)
Surgical and medical procedures Various medical procedures	2.7% 4/150 • Randomization through 12 months (final endpoint of trial)	3.3% 5/151 • Randomization through 12 months (final endpoint of trial)
Gastrointestinal disorders GI issues	3.3% 5/150 • Randomization through 12 months (final endpoint of trial)	1.3% 2/151 • Randomization through 12 months (final endpoint of trial)
Psychiatric disorders Mental health challenges	0.67% 1/150 • Randomization through 12 months (final endpoint of trial)	0.00% 0/151 • Randomization through 12 months (final endpoint of trial)
Musculoskeletal and connective tissue disorders Fractured bones/torn ligaments	1.3% 2/150 • Randomization through 12 months (final endpoint of trial)	1.3% 2/151 • Randomization through 12 months (final endpoint of trial)
Cardiac disorders Heart rate/BP/ afib	3.3% 5/150 • Randomization through 12 months (final endpoint of trial)	4.0% 6/151 • Randomization through 12 months (final endpoint of trial)
Immune system disorders Immune-related issues	1.3% 2/150 • Randomization through 12 months (final endpoint of trial)	0.00% 0/151 • Randomization through 12 months (final endpoint of trial)
Infections and infestations Infections from ticks	0.67% 1/150 • Randomization through 12 months (final endpoint of trial)	0.66% 1/151 • Randomization through 12 months (final endpoint of trial)
Renal and urinary disorders Kidney related issues	1.3% 2/150 • Randomization through 12 months (final endpoint of trial)	0.00% 0/151 • Randomization through 12 months (final endpoint of trial)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer related issues	1.3% 2/150 • Randomization through 12 months (final endpoint of trial)	1.3% 2/151 • Randomization through 12 months (final endpoint of trial)
Injury, poisoning and procedural complications Accidents	0.00% 0/150 • Randomization through 12 months (final endpoint of trial)	1.3% 2/151 • Randomization through 12 months (final endpoint of trial)

Additional Information

Gary G. Bennett, PhD

Duke University

Phone: 919-684-4510

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place