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

NCT ID: NCT03215472

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-21

Study Completion Date

2018-03-12

Brief Summary

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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.

Detailed Description

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Specifically, this study aims to

1. To test the feasibility of the DASH Cloud intervention compared to education control among women with prehypertension and hypertension via a 3-month randomized controlled trial.
2. To evaluate the preliminary efficacy of the DASH Cloud intervention relative to education control on blood pressure, weight and medication adherence at 3 months.

This study will enroll 50 adult women aged 21-70 with pre-hypertension or hypertension in a 3-month randomized controlled trial to test the initial feasibility of DASH Cloud. Women will be randomized to either the DASH Cloud intervention or DASH Light and followed up 3 months post randomization. The investigators will recruit participants from the Durham, NC area.

Women randomized to the DASH Cloud intervention will be asked to track their diet daily using a smartphone diet tracking app. Based on the foods/beverages entered, the intervention will send daily or weekly text messages with feedback about DASH adherence and information videos about how to follow DASH. Women randomized to DASH Light will also be asked to track their diet using the smartphone diet tracking app and will receive basic informational materials about DASH.

Conditions

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Diet Modification Hypertension Women's Health Cardiovascular Diseases Digital Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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DASH Cloud intervention

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.

Group Type EXPERIMENTAL

DASH Cloud

Intervention Type 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 Light

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

Group Type EXPERIMENTAL

Nutritionix Track app

Intervention Type OTHER

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

Interventions

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DASH Cloud

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.

Intervention Type OTHER

Nutritionix Track app

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

Intervention Type OTHER

Other Intervention Names

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DASH Light

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dori M Steinberg, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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The Sarah W. Stedman Nutrition and Metabolism Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37791242 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33284116 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Pro00081972

Identifier Type: -

Identifier Source: org_study_id

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