HypertensionDISHNCT06616818
DASH Diet Intervention for Systemic Hypertension in Adolescents
A study testing DASH-FV and nutrition counselling only in people with Hypertension and Food Insecurity, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Hypertension, Food Insecurity
- What is being tested?
- DASH-FV and nutrition counselling only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 30 Dec 2031
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12 to 17 years of age at baseline visit
- Elevated blood pressure or hypertension
Who cannot join
- Inability to eat by mouth
- Secondary hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents.
Read the detailed description
Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents.
- Conditions
- Hypertension, Food Insecurity
- Being tested
- DASH-FV, nutrition counselling only
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH-FVOther
12weeks of fruit and vegetable delivery to the home
nutrition counselling onlyOther
nutrition counselling as part of standard of care
| Study group | Role | What they receive |
|---|---|---|
| STANDARD | Placebo comparator | Nutrition counseling only as part of standard of care Receives: Other: nutrition counselling only |
| DASH diet toolkit arm | Active comparator | A group of participants receiving DASH diet intervention Receives: Other: DASH-FV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vegetable and fruit intake
Change in the average number of servings of vegetables and fruits consumed in a day.
Measured: 12 weeks and 6months
Secondary outcomes (1)
Systolic blood pressure
Change in manual, in office systolic blood pressure
Measured: 12 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Aug 2026 (estimated)
- Primary completion31 Aug 2031 (estimated)
- Study completion30 Dec 2031 (estimated)
Why it stopped: Funding not awarded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- 6 months of produce delivery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carissa Baker-Smith, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616818
- Sponsor's protocol ID
- Nemours DASH Diet Study
- Acronym
- DISH
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request and upon completion.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DASH Diet Intervention for Systemic Hypertension in Adolescents
- ClinicalTrials.gov ID
- NCT06616818
- Acronym / sponsor ID
- DISH / Nemours DASH Diet Study
- Conditions
- Hypertension, Food Insecurity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not awarded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2031 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 27 Sep 2024 (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.
Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents.
Detailed description
Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 6 months of produce delivery.
| Arm | Type | Receives |
|---|---|---|
| STANDARD | Placebo comparator | Other: nutrition counselling onlyNutrition counseling only as part of standard of care |
| DASH diet toolkit arm | Active comparator | Other: DASH-FVA group of participants receiving DASH diet intervention |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 12 to 17 years of age at baseline visit
- Elevated blood pressure or hypertension
Key exclusion criteria (2 listed)
- Inability to eat by mouth
- Secondary hypertension
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-FV12weeks of fruit and vegetable delivery to the home | Other | DASH diet toolkit arm |
| nutrition counselling onlynutrition counselling as part of standard of care | Other | STANDARD |
Primary outcome
Change in vegetable and fruit intake
Time frame: 12 weeks and 6months
Change in the average number of servings of vegetables and fruits consumed in a day.
1 secondary outcome
Systolic blood pressure
Time frame: 12 weeks and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Yes. Upon request and upon completion.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-FV and nutrition counselling only in people with Hypertension and Food Insecurity, run by Nemours Children's Clinic 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 14 Aug 2025. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in vegetable and fruit intake (time frame: 12 weeks and 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.