Clinical trial NCT03215472: DASH Cloud: Using Digital Health to Improve Adherence to the DASH Diet Among Women
Official title: DASH Cloud: Using Digital Health to Improve Adherence to the DASH Diet Among Women at Risk for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Hypertension
Women's Health
Cardiovascular Diseases
Digital Health
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 59
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-month randomized controlled trial to test the initial feasibility of DASH Cloud, a digital health intervention for women at risk for CVD
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to the DASH Diet
timeFrame: 3 months
Secondary outcomes:
measure: Change in Blood Pressure
timeFrame: Baseline, 3 months
measure: Change in Weight
timeFrame: Baseline, 3 months
measure: Engagement
timeFrame: 3 months
measure: Engagement
timeFrame: 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: The Sarah W. Stedman Nutrition and Metabolism Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Dori M Steinberg, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.