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

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.

Study Overview

• Status: Completed
• Conditions: Food Insecurity; Nutrition Poor
• Intervention / Treatment: Behavioral: Food as Medicine Delivery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94609
      • UCSF Benioff Children's Hospital Oakland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Behavioral: Food as Medicine Delivery; 12 consecutive weeks of home-delivered vegetables plus whole grain foods along with weekly text containing educational video
OTHER: 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.	Behavioral: Food as Medicine Delivery; 12 consecutive weeks of home-delivered vegetables plus whole grain foods along with weekly text containing educational video

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vegetable consumption (servings/day) for child	24-diet diet recall (total vegetables)	6 months
whole grains consumption (ounce equivalents/day) for child	24-diet diet recall (total vegetables)	6 months
reported total cups of vegetables per day (for adult)	Fruit and Vegetable checklist	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
food security	Core food security module (up to 18 questions)	3 months
food security	Core food security module (up to 18 questions)	6 months
Body mass Index	Body mass index, calculated	6 months
Liking Scale (Vegetables)	This scale (never tried, do not like, like a little, like a lot) has been validated in children as young as 4th grade. Responses will be dichotomized to represent "Ever tried" ('Never tried' versus all other responses) and "Like it" ('Never tried' or 'do not like' versus 'like a little' and 'like a lot')	6 months
Liking Scale (Whole grains)	This scale (never tried, do not like, like a little, like a lot) has been validated in children as young as 4th grade. Responses will be dichotomized to represent "Ever tried" ('Never tried' versus all other responses) and "Like it" ('Never tried' or 'do not like' versus 'like a little' and 'like a lot')	6 months

Collaborators and Investigators

• Sponsor: UCSF Benioff Children's Hospital Oakland
• Collaborators: Battery Powered
• Investigators: Principal Investigator: June Tester, MD, MPH, Assistant Clinical Scientist

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 3, 2019
• Primary Completion (ACTUAL): November 13, 2020
• Study Completion (ACTUAL): January 27, 2021

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (ACTUAL): November 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: vegetables; food insecurity; diet quality; randomized intervention; home-delivery intervention; whole grains
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 2018-062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No