Sanctuary Farm Prescription in Adolescents | NCT07218588

Studies
Sanctuary Farm Prescription in Adolescents

NCT07218588

Sponsor

Nemours Children's Clinic

Status

Recruiting

Last Update Posted

May 8, 2026Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Obesity &Amp; Overweight
Adolescence

Interventions

dietary / produce

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

ID	Type	Description	Link
ITPR2025333	Other Identifier	Nemours ITP Number

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2025Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Oct 16, 2025

First Submission Date that Met QC Criteria

Oct 16, 2025

First Posted Date

Oct 20, 2025Actual

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

May 4, 2026

Last Update Posted Date

May 8, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carissa Baker-Smith, Director of Research, Nemours Cardiac Center; Director of Preventive Pediatric Cardiology, Nemours Children's ClinicPrincipal Investigator

Lead Sponsor

Nemours Children's ClinicOTHER

Collaborators

Name	Class
Thomas Jefferson University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this research study is to learn if an 8-week produce prescription program (in partnership with a local urban farm) can increase fruit and vegetable consumption in overweight teens and improve their blood pressure and weight. The main questions are:

Is a produce prescription program in overweight teens feasible?
Will a produce prescription with educational videos increase weekly fruit and vegetable intake?
Will a produce prescription with educational videos improve blood pressure and weight for height?

Researchers will compare the teens' fruit and vegetable intake, blood pressure and weight for height before and after the produce prescription. Researchers will also see how feasible it is by measuring the number of produce prescriptions are picked up by the families and how many educational videos are viewed.

Participants will:

complete questionnaires related to their diet and nutrition
measure their blood pressure and weight at the beginning and end of the study
obtain weekly produce prescriptions

Detailed Description

The overall objectives of this study are to (1) assess the feasibility of produce-prescription in partnership with a local urban farm (Sanctuary Farm) and to (2) determine if an 8-week produce prescription combined with four 20-minute educational videos improves weekly fruit and vegetable intake and improves BMI and BP in adolescents with dysfunctional adiposity. We hypothesize that implementing a produce prescription program in partnership with a local urban farm is feasible and can potentially overcome barriers to healthy eating. Our team of clinicians and health educators has extensive experience leading dietary intervention studies and community-engaged, patient-centered research.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Produce prescription	Experimental	weekly produce pickup	Other: dietary / produce

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dietary / produce	Other	8-week produce prescription pickup	Produce prescription

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent produce pickups completed	Percent of produce pickups completed	8 weeks
Percent of videos viewed	Percent of educational videos viewed	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Blood Pressure	Change in blood pressure from baseline	8 weeks
Change in BMI	Change in BMI from baseline	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion

Patients seen at Nemours TJU Primary Care Clinic
Ages 12-17 years at enrollment
BMI > or = 85th percentile
English Speaking
Willing to provide parental permission and ability to provide child assent for the study

Exclusion

Children with neurocognitive delays that would limit participation or ability to assent
Use of G-tube/J-tube
Food allergies that in the opinion of the investigators would interfere with ability to participate.

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

Name	Role	Phone	Extension	Email
Bridgette Hindt, BS	Contact	302-531-8295		bridgette.hindt@nemours.org

Overall Officials

Name	Affiliation	Role
Carissa Baker-Smith, MD, MPH, MS	Nemours Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nemours Children's Hospital, DE	Active, not recruiting	Wilmington	Delaware	19803	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004032	Diet

Ancestor Terms

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided