DASH Cloud: Using Digital Health to Improve Adherence to the DASH Diet Among Women
NCT ID: NCT03215472
Last Updated: 2024-04-12
Study Results
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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COMPLETED
NA
59 participants
INTERVENTIONAL
2017-07-21
2018-03-12
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
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.
Dash Light
Group 2 participants will be asked to use the Nutritionix app daily and receive publicly available written materials on the DASH diet.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* active malignancy; active psychosis or recent psychiatric institutionalization
* current pregnancy or lactation
* current participation in a similar trial.
21 Years
70 Years
ALL
Yes
Sponsors
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Duke University
OTHER
Responsible Party
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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
Countries
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Pro00081972
Identifier Type: -
Identifier Source: org_study_id
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