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

NCT ID: NCT03875768

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-29
• Study Completion Date: 2023-03-20

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.

Conditions

Hypertension; Health Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Tracking plus coaching

Intervention Type: BEHAVIORAL

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.

Control

Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary G. Bennett, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Pro00101689

Identifier Type: -

Identifier Source: org_study_id