DASH Diet Intervention for Systemic Hypertension in Adolescents

Not Applicable

Not yet recruiting

• Conditions: Hypertension; Food Insecurity
• Interventions: Other: nutrition counselling only; Other: DASH-FV

• Registration Number: NCT06616818
• Lead Sponsor: Nemours Children's Clinic

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Study First Posted: 2024-09-27
• Last Update Posted: 2024-09-27
• Study Start: 2025-08-01
• Primary Completion: 2030-08-31
• Study Completion: 2030-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

Inability to eat by mouth Secondary hypertension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STANDARD	nutrition counselling only	Nutrition counseling only as part of standard of care
DASH diet toolkit arm	DASH-FV	A group of participants receiving DASH diet intervention

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Systolic blood pressure	12 weeks and 6 months	Change in manual, in office systolic blood pressure

Trial Locations

Locations (1)

Nemours Cardiac Center; 🇺🇸 Wilmington, Delaware, United States