DASH Cloud: Using Digital Health to Improve Adherence to the DASH Diet Among Women

NCT03215472 | Completed

• 1 other identifier: Pro00081972
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test whether a digital health intervention (DASH Cloud) using smartphones can improve diet quality among women at risk for cardiovascular disease. The DASH (Dietary Approaches to Stop Hypertension) Diet has been proven to lower blood pressure, yet dissemination efforts remain poor. This study aims to use technology to improve adherence to DASH.

Conditions

Diet Modification; Hypertension; Women's Health; Cardiovascular Diseases; Digital Health

Outcome Measures

Primary Outcomes (1)

• Adherence to the DASH Diet

  Dietary intake data will be collected using NCI's Automated Self-Administered 24-hour Recall tool.

  3 months

Secondary Outcomes (4)

• Change in Blood Pressure

  Baseline, 3 months

• Change in Weight

  Baseline, 3 months

• Engagement

  3 months

• Engagement

  3 months

Study Arms (2)

DASH Cloud intervention

EXPERIMENTAL

In group 1, participants will be instructed to input their dietary intake daily for three months using the Nutritionix app. A participant's data will automatically be uploaded from the Nutritionix app via the API that links the device with DASH Cloud. DASH Cloud will run an algorithm and send daily or weekly feedback text messages reflecting DASH adherence. The intervention components include tailored feedback texts, and behavioral skills training videos.

Other: DASH Cloud

Dash Light

EXPERIMENTAL

Group 2 participants will be asked to use the Nutritionix app daily and receive publicly available written materials on the DASH diet.

Other: Nutritionix Track app

Interventions

DASH Cloud OTHER

With DASH Cloud, the investigators will ask participants to track their diet daily using a commercial diet tracking app. The investigators will retrieve the diet data on our DASH Cloud platform and provide tailored feedback about a participant's DASH adherence via fully automated daily or weekly text messages. These feedback messages will describe both an individual's absolute performance and change over time. The investigators also include theory-driven tailored content that reinforces successes, offers motivational strategies, and offers short behavior change tips.

DASH Cloud intervention

Nutritionix Track app OTHER

DASH Light Control participants will be asked to use the Nutritionix app daily and receive publicly available written materials on the DASH diet.

Also known as: DASH Light

Dash Light

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages 21-70 years; BMI \>18.5 kg/m2
• on antihypertensive medication or systolic blood pressure 120-159 mmHg and/or diastolic blood pressure of 80-99
• current use of a smartphone and willingness to be texted daily or weekly
• an email account; spoken and written English fluency.

You may not qualify if:

• CVD event in prior 6 months
• active malignancy; active psychosis or recent psychiatric institutionalization
• current pregnancy or lactation
• current participation in a similar trial.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

The Sarah W. Stedman Nutrition and Metabolism Center

Durham, North Carolina, 27708, United States

Location

Related Publications (2)

• Kay MC, Miller HN, Askew S, Spaulding EM, Chisholm M, Christy J, Yang Q, Steinberg DM. Patterns of Engagement With an Application-Based Dietary Self-Monitoring Tool Within a Randomized Controlled Feasibility Trial. AJPM Focus. 2022 Sep 29;1(2):100037. doi: 10.1016/j.focus.2022.100037. eCollection 2022 Dec.

  PMID: 37791242 DERIVED

• Steinberg DM, Kay MC, Svetkey LP, Askew S, Christy J, Burroughs J, Ahmed H, Bennett GG. Feasibility of a Digital Health Intervention to Improve Diet Quality Among Women With High Blood Pressure: Randomized Controlled Feasibility Trial. JMIR Mhealth Uhealth. 2020 Dec 7;8(12):e17536. doi: 10.2196/17536.

  PMID: 33284116 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Dori M Steinberg, PhD, RD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3-month randomized controlled trial to test the initial feasibility of DASH Cloud, a digital health intervention for women at risk for CVD

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: July 12, 2017
• Study Start: July 21, 2017
• Primary Completion: March 12, 2018
• Study Completion: March 12, 2018
• Last Updated: April 12, 2024

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)