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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04639687
Acronym
FAM
Enrollment
68
Registered
2020-11-20
Start date
2019-04-03
Completion date
2021-01-27
Last updated
2021-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Insecurity, Nutrition Poor

Keywords

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

Brief summary

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

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.

Interventions

BEHAVIORALFood as Medicine Delivery

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

Sponsors

Battery Powered
CollaboratorUNKNOWN
UCSF Benioff Children's Hospital Oakland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
vegetable consumption (servings/day) for child6 months24-diet diet recall (total vegetables)
whole grains consumption (ounce equivalents/day) for child6 months24-diet diet recall (total vegetables)
reported total cups of vegetables per day (for adult)6 monthsFruit and Vegetable checklist

Secondary

MeasureTime frameDescription
Liking Scale (Whole grains)6 monthsThis 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')
Liking Scale (Vegetables)6 monthsThis 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')
food security3 monthsCore food security module (up to 18 questions)
Body mass Index6 monthsBody mass index, calculated

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026