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Food as Medicine: Evaluating the Impact of Home-delivered Vegetables and Whole Grains on Diet of Food-insecure Families

NCT ID: NCT04639687

Last Updated: 2021-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2021-01-27

Brief Summary

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Food insecurity predisposes to poor diet, thereby increasing risk for diet-sensitive chronic disease. This trial is to evaluate the impact of a model of weekly home-delivery of locally-grown vegetables along with selected whole grains on diet among low-income children living in a household with food insecurity. The investigators plan to enroll children (10-15 years) who will participate along with their parent/caregiver. Intervention will consist of 12 weeks of weekly delivered food plus recipes and text-messaged links to cooking instruction. Dyads will be randomized (2:1) to either immediate intervention or a wait-list control group, and diet and diet-related behaviors will be assessed in-person as well as over the telephone.

Detailed Description

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Children and their families who are seen at the investigators primary care clinic will be screened for eligibility by the research team study staff, and caregiver/parents will be asked a short 2-item screener about access to food. This screener has been called the "Hunger Vital Sign". When a screen for household food security is positive, caregivers are invited to participate in this study along with their child, as a dyad.

This is a randomized clinical trial. The first activity consists of an in-person visit where child and caregiver answer survey questions related to diet (specifically regarding vegetable and whole grain purchase and consumption). Anthropometrics are measured. The child has a 24-hour diet recall that is conducted in person at this visit, and then two more times in the intervening time (approximately 2 weeks). They are randomized (2:1) at this visit to either receive 12 weeks of deliveries immediately (starting in approximately 2 weeks) or after a delay of 3 months, when they serve as the delayed-intervention control group.

Immediate intervention group receives a weekly delivery of vegetables and whole grains as well as 1-2 weekly text messages that contain education such as links to cooking tips and videos.

After 3 months, both immediate intervention and the delayed intervention groups return for a second in-person visit, and complete all of the visit activities. Delayed intervention group starts their deliveries at this point.

After 3 months, the delayed intervention group returns for a third in-person visit, though the immediate intervention participants complete their follow-up survey questions over the telephone, only.

This home delivery model, done in coordination with a community-supported has been successfully-piloted in a population of low-income dyads with a child having prediabetes.

Conditions

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Food Insecurity Nutrition Poor

Keywords

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randomized intervention home-delivery intervention vegetables whole grains food insecurity diet quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group A is randomized to intermediate intervention, and change in measured outcomes is changed to that of Group B, which is a wait-list control group. Group B gets intervention later, but data contributes to follow-up up data rather than randomized controlled trial data.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate intervention

If randomized to this group, household of child and participating caregiver receives 12 weekly deliveries of vegetables plus added whole grains, along with text messages containing links to cooking instruction videos

Group Type EXPERIMENTAL

Food as Medicine Delivery

Intervention Type BEHAVIORAL

12 consecutive weeks of home-delivered vegetables plus whole grain foods along with weekly text containing educational video

Wait list control (delayed intervention)

If randomized to this group, participants do not get any intervention activities for the first 12 weeks, and their outcome data at V2 contribute as controls. For ethical reasons, this low-income population ultimately gets the intervention (food)later, and data after they receive the intervention contributes to follow-up data only.

Group Type OTHER

Food as Medicine Delivery

Intervention Type BEHAVIORAL

12 consecutive weeks of home-delivered vegetables plus whole grain foods along with weekly text containing educational video

Interventions

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Food as Medicine Delivery

12 consecutive weeks of home-delivered vegetables plus whole grain foods along with weekly text containing educational video

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* child between 10-15 at time of enrollment whose caregiver screens as positive for food insecurity during visit to primary clinic
* child must reside in household with caregiver at least 5 out of 7 days a week
* dyad must reside in Oakland, CA (delivery range for farm)

Exclusion Criteria

* Not able to consume wheat or other grains
* Caregiver and child must have cognitive capability to complete survey materials (exclude non-verbal autistic, developmental delay)
* Unable to communicate in either English or Spanish
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Battery Powered

UNKNOWN

Sponsor Role collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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June Tester, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Assistant Clinical Scientist

Locations

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UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Site Status

Countries

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United States

Other Identifiers

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2018-062

Identifier Type: -

Identifier Source: org_study_id