DASH Diet Intervention for Systemic Hypertension in Adole... | NCT06616818

Studies
DASH Diet Intervention for Systemic Hypertension in Adolescents

NCT06616818

Sponsor

Nemours Children's Clinic

Status

Withdrawn

Last Update Posted

Aug 14, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hypertension
Food Insecurity

Interventions

DASH-FV
nutrition counselling only

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding not awarded

Expanded Access Info

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Aug 31, 2031Estimated

Completion Date

Dec 30, 2031Estimated

First Submitted Date

Sep 25, 2024

First Submission Date that Met QC Criteria

Sep 25, 2024

First Posted Date

Sep 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2025

Last Update Posted Date

Aug 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
STANDARD	Placebo Comparator	Nutrition counseling only as part of standard of care	Other: nutrition counselling only
DASH diet toolkit arm	Active Comparator	A group of participants receiving DASH diet intervention	Other: DASH-FV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DASH-FV	Other	12weeks of fruit and vegetable delivery to the home	DASH diet toolkit arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in vegetable and fruit intake	Change in the average number of servings of vegetables and fruits consumed in a day.	12 weeks and 6months

Secondary Outcomes

Measure	Description	Time Frame
Systolic blood pressure	Change in manual, in office systolic blood pressure	12 weeks and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 12 to 17 years of age at baseline visit
Elevated blood pressure or hypertension

Exclusion Criteria:

Inability to eat by mouth
Secondary hypertension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nemours Cardiac Center		Wilmington	Delaware	19803	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Upon request and upon completion.

Types

Clinical Study Report (CSR)

Time Frame

6 months following study completion.

Access Criteria

Available upon request, but only deidentifed data.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided