Diet ModificationNCT03215472
DASH Cloud: Using Digital Health to Improve Adherence to the DASH Diet Among Women
A study testing DASH Cloud and Nutritionix Track app in people with Diet Modification and Hypertension, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Modification, Hypertension, Women's Health
- What is being tested?
- DASH Cloud and Nutritionix Track app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2017to 12 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- CVD event in prior 6 months
- active malignancy; active psychosis or recent psychiatric institutionalization
- current pregnancy or lactation
- current participation in a similar trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sarah W. Stedman Nutrition and Metabolism Center
Durham, North Carolina, 27708
About this study
Official title: DASH Cloud: Using Digital Health to Improve Adherence to the DASH Diet Among Women at Risk for Cardiovascular Disease
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.
Read the detailed description
Specifically, this study aims to
- 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.
- 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.
- Being tested
- DASH Cloud, Nutritionix Track app
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH CloudOther
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 appOther
Also called DASH Light
DASH Light Control participants will be asked to use the Nutritionix app daily and receive publicly available written materials on the DASH diet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Nutritionix Track app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the DASH Diet
Dietary intake data will be collected using NCI's Automated Self-Administered 24-hour Recall tool.
Measured: 3 months
Secondary outcomes (4)
Change in Blood Pressure
Blood pressure will be measured at baseline and 3 months in the upper arm in triplicate at 1-minute intervals. Measurements will be obtained using the validated Omron HEM-907XL blood pressure monitor.
Measured: Baseline, 3 months
Change in Weight
Weight will be collected in kilograms at baseline and 3 months using a calibrated digital scale.
Measured: Baseline, 3 months
Engagement
Utilization of intervention component (daily diet tracking using Nutritionix app) at 3 months. This will be measured by the proportion of participants completing daily dietary self-monitoring.
Measured: 3 months
Engagement
Utilization of intervention component (review of skills training videos) at 3 months. This will be measured by the number of clicks to skills training via video tracking software.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start21 Jul 2017
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dori M Steinberg, PhD, RD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215472
- Sponsor's protocol ID
- Pro00081972
- Status last verified
- Mar 2018
- First submitted
- 20 Jun 2017
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37791242Steinberg 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.
PubMed 33284116
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DASH Cloud: Using Digital Health to Improve Adherence to the DASH Diet Among Women at Risk for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03215472
- Acronym / sponsor ID
- Pro00081972
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| DASH Cloud intervention | Experimental | Other: DASH CloudIn 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 Light | Experimental | Other: Nutritionix Track appGroup 2 participants will be asked to use the Nutritionix app daily and receive publicly available written materials on the DASH diet. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- CVD event in prior 6 months
- active malignancy; active psychosis or recent psychiatric institutionalization
- current pregnancy or lactation
- current participation in a similar trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH CloudWith 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. | Other | DASH Cloud intervention |
| Nutritionix Track appAlso: DASH LightDASH Light Control participants will be asked to use the Nutritionix app daily and receive publicly available written materials on the DASH diet. | Other | Dash Light |
Primary outcome
Adherence to the DASH Diet
Time frame: 3 months
Dietary intake data will be collected using NCI's Automated Self-Administered 24-hour Recall tool.
4 secondary outcomes
Change in Blood Pressure
Time frame: Baseline, 3 months
Change in Weight
Time frame: Baseline, 3 months
Engagement
Time frame: 3 months
Engagement
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Derived from this study: PubMed 37791242Kay 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.
- Derived from this study: PubMed 33284116Steinberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dori M Steinberg, PhD, RD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH Cloud and Nutritionix Track app in people with Diet Modification and Hypertension, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the DASH Diet (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03215472, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.