HypertensionNOSHNCT02796313
Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities
A study testing DASH Groceries + Weekly Sessions and Groceries + Brochure in people with Hypertension, run by Washington State University at 4 sites in United States.
Trial summary
We will conduct a randomized trial to test our DASH (Dietary Approaches to Stop Hypertension) based intervention in 370 adult American Indians with inadequately controlled systolic blood pressure (≥130 mmHg). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- DASH Groceries + Weekly Sessions and Groceries + Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Nov 2017to 4 Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must:
- be at least 18 years old;
- have had diagnosed hypertension for at least 1 year;
- be on a stable routine of antihypertensive medications for at least 2 months OR not currently medicated, without anticipated changes for the duration of the study;
- have systolic BP ≥ 130 mmHg at the past 2 clinic visits and at the screening call;
- have access to regular medical care and permission from their primary care provider to participate (study staff obtain verbal permission before recruiting participants);
- be physically and cognitively able to use the home BP monitoring device;
- be willing and able to follow all other study procedures.
Who cannot join
- People are ineligible if they:
- experienced incident cardiovascular disease or stroke within the previous 6 months;
- have a known diagnosis of secondary hypertension (e.g., renal artery stenosis);
- have a recent history of high blood potassium due to certain medications that can raise potassium levels;
- have diagnosed Stage 4 or 5 kidney disease;
- are currently or planning to become pregnant during the course of the study;
- are participating in another health research study involving hypertension;
- are receiving treatment for cancer or another serious or terminal medical condition.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Chickasaw Nation Health Clinic
Purcell, Oklahoma, 73080
Avera Research Institute
Rapid City, South Dakota, 57702
Seattle Indian Health Board
Seattle, Washington, 98144
NATIVE Project
Spokane, Washington, 99201
About this study
We will conduct a randomized trial to test our DASH (Dietary Approaches to Stop Hypertension) based intervention in 370 adult American Indians with inadequately controlled systolic blood pressure (≥130 mmHg). Over the 5 years of the project, we will recruit and randomize 200 participants from each of 4 urban sites: two in Washington, one in Oklahoma, and one in South Dakota.
Read the detailed description
All participants complete 3 data collection visits following an over-the-phone eligibility screening call (baseline, week 8, and week 12). Participants will be randomized into either the control group or the intervention group at the baseline visit.
All participants will receive 8 weekly credits for groceries and will be given equipment for monitoring their BP at home. Study staff will help participants place their grocery orders each week, and will collect readings from the home BP monitoring equipment at the same time. This data will be used to understand whether the intervention is effective for controlling BP.
All participants will be encouraged to maintain their regular levels of physical activity and receive treatment as usual from their healthcare providers.
The control group participants will receive an American Heart Association printed brochure about the health benefits of a low-salt diet. All foods will be available to purchase, including those that do not meet the DASH diet guidelines.
The intervention group participants will receive 1 hour of nutritional counseling over the phone and a personalized prescription for the low-salt DASH diet based on estimated calorie needs at baseline, followed by weekly 20-minute phone calls in weeks 1-8 to provide extra support.
The intervention group's food choices will be limited to fresh produce and a pre-determined list of other foods included in the DASH diet. During weekly phone calls, the dietitian will use a structured phone curriculum to discuss in more detail a different component of the DASH diet, followed by goal setting related to that component. Through small goal setting each week, participants will receive ongoing support to improve full adherence to the DASH diet by the end of week 8.
- Conditions
- Hypertension
- Being tested
- DASH Groceries + Weekly Sessions, Groceries + Brochure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH Groceries + Weekly SessionsBehavioural
Intervention group participants will receive 1 hour of in-person nutritional counseling and a personalized prescription for the low-salt DASH diet based on estimated calorie needs at baseline, followed by weekly 20-minute phone calls in weeks 1-8 to provide extra support.
Groceries + BrochureBehavioural
Control group participants will receive a printed brochure about the health benefits of a low-salt diet. They will place an unrestricted $35 grocery order for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group will receive tailored advice on adopting a low-sodium DASH diet, comprising nutritional education and ongoing guidance for purchasing heart-healthy foods, plus a weekly $35 credit for groceries. Receives: Behavioral: DASH Groceries + Weekly Sessions |
| Control Group | Active comparator | Participants in the control group will receive printed educational materials with general information about low-salt diets plus a weekly $35 credit for groceries. Receives: Behavioral: Groceries + Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved blood pressure
Systolic blood pressure measurements collected throughout the study.
Measured: 12 weeks
Secondary outcomes (3)
Improved urinary sodium/potassium levels
Measured by 24 hour urine samples collected at 3 time points.
Measured: 12 weeks
Improved BMI
Measured by weight and height. Waist circumference will also be measured.
Measured: 12 weeks
Improved blood lipids
Measured by cholesterol panel at 3 time points
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start17 Nov 2017
- Primary completion4 Mar 2023
- Study completion4 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma State University
- Responsible party
- Principal investigator, Dedra Buchwald, Washington State University
- Investigators
- Dedra Buchwald, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796313
- Sponsor's protocol ID
- 1R01HL126578
- Acronym
- NOSH
- Status last verified
- Sep 2023
- First submitted
- 7 Jun 2016
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sinclair K, Nguyen CJ, Wetherill MS, Nelson K, Jackson AM, Taniguchi T, Jernigan VBB, Buchwald D. Native opportunities to stop hypertension: study protocol for a randomized controlled trial among urban American Indian and Alaska Native adults with hypertension. Front Public Health. 2023 Jun 2;11:1117824. doi: 10.3389/fpubh.2023.1117824. eCollection 2023.
PubMed 37333529
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities
- ClinicalTrials.gov ID
- NCT02796313
- Acronym / sponsor ID
- NOSH / 1R01HL126578
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- Oklahoma State University
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 4 Mar 2023 (actual)
- First posted
- 10 Jun 2016 (estimated)
- 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.
We will conduct a randomized trial to test our DASH (Dietary Approaches to Stop Hypertension) based intervention in 370 adult American Indians with inadequately controlled systolic blood pressure (≥130 mmHg). Over the 5 years of the project, we will recruit and randomize 200 participants from each of 4 urban sites: two in Washington, one in Oklahoma, and one in South Dakota.
Detailed description
All participants complete 3 data collection visits following an over-the-phone eligibility screening call (baseline, week 8, and week 12). Participants will be randomized into either the control group or the intervention group at the baseline visit.
All participants will receive 8 weekly credits for groceries and will be given equipment for monitoring their BP at home. Study staff will help participants place their grocery orders each week, and will collect readings from the home BP monitoring equipment at the same time. This data will be used to understand whether the intervention is effective for controlling BP.
All participants will be encouraged to maintain their regular levels of physical activity and receive treatment as usual from their healthcare providers.
The control group participants will receive an American Heart Association printed brochure about the health benefits of a low-salt diet. All foods will be available to purchase, including those that do not meet the DASH diet guidelines.
The intervention group participants will receive 1 hour of nutritional counseling over the phone and a personalized prescription for the low-salt DASH diet based on estimated calorie needs at baseline, followed by weekly 20-minute phone calls in weeks 1-8 to provide extra support.
The intervention group's food choices will be limited to fresh produce and a pre-determined list of other foods included in the DASH diet. During weekly phone calls, the dietitian will use a structured phone curriculum to discuss in more detail a different component of the DASH diet, followed by goal setting related to that component. Through small goal setting each week, participants will receive ongoing support to improve full adherence to the DASH diet by the end of week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: DASH Groceries + Weekly SessionsParticipants in the intervention group will receive tailored advice on adopting a low-sodium DASH diet, comprising nutritional education and ongoing guidance for purchasing heart-healthy foods, plus a weekly $35 credit for groceries. |
| Control Group | Active comparator | Behavioral: Groceries + BrochureParticipants in the control group will receive printed educational materials with general information about low-salt diets plus a weekly $35 credit for groceries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- be at least 18 years old;
- have had diagnosed hypertension for at least 1 year;
- be on a stable routine of antihypertensive medications for at least 2 months OR not currently medicated, without anticipated changes for the duration of the study;
- have systolic BP ≥ 130 mmHg at the past 2 clinic visits and at the screening call;
- have access to regular medical care and permission from their primary care provider to participate (study staff obtain verbal permission before recruiting participants);
Key exclusion criteria (8 listed)
- experienced incident cardiovascular disease or stroke within the previous 6 months;
- have a known diagnosis of secondary hypertension (e.g., renal artery stenosis);
- have a recent history of high blood potassium due to certain medications that can raise potassium levels;
- have diagnosed Stage 4 or 5 kidney disease;
- are currently or planning to become pregnant during the course of the study;
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 Groceries + Weekly SessionsIntervention group participants will receive 1 hour of in-person nutritional counseling and a personalized prescription for the low-salt DASH diet based on estimated calorie needs at baseline, followed by weekly 20-minute phone calls in weeks 1-8 to provide extra support. | Behavioural | Intervention Group |
| Groceries + BrochureControl group participants will receive a printed brochure about the health benefits of a low-salt diet. They will place an unrestricted $35 grocery order for 8 weeks. | Behavioural | Control Group |
Primary outcome
Improved blood pressure
Time frame: 12 weeks
Systolic blood pressure measurements collected throughout the study.
3 secondary outcomes
Improved urinary sodium/potassium levels
Time frame: 12 weeks
Improved BMI
Time frame: 12 weeks
Improved blood lipids
Time frame: 12 weeks
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 2 Oct 2023.
- Derived from this study: PubMed 37333529Sinclair K, Nguyen CJ, Wetherill MS, Nelson K, Jackson AM, Taniguchi T, Jernigan VBB, Buchwald D. Native opportunities to stop hypertension: study protocol for a randomized controlled trial among urban American Indian and Alaska Native adults with hypertension. Front Public Health. 2023 Jun 2;11:1117824. doi: 10.3389/fpubh.2023.1117824. eCollection 2023.
- 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.
Dedra Buchwald principal investigator
Washington State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH Groceries + Weekly Sessions and Groceries + Brochure in people with Hypertension, run by Washington State University at 4 sites 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 8 inclusion and 8 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 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Improved blood pressure (time frame: 12 weeks). 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 NCT02796313, which also lists 1 linked publication.
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 2 Oct 2023.