DASH Diet Intervention for Systemic Hypertension in Adolescents

NCT06616818 | Withdrawn DMC

• 1 other identifier: Nemours DASH Diet Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Food Insecurity

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Systolic blood pressure

  12 weeks and 6 months

Study Arms (2)

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

DASH-FV OTHER

12weeks of fruit and vegetable delivery to the home

DASH diet toolkit arm

nutrition counselling only OTHER

nutrition counselling as part of standard of care

STANDARD

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Inability to eat by mouth
• Secondary hypertension

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Cardiac Center

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: 6 months of produce delivery.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 31, 2031
• Study Completion (Estimated): December 30, 2031
• Last Updated: August 14, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months following study completion.
• Access Criteria: Available upon request, but only deidentifed data.

Locations

US (1)