Clinical trial NCT04639687: Food as Medicine: Evaluating the Impact of Home-delivered Vegetables and Whole Grains on Diet of Food-insecure Families
Official title: Food as Medicine: Evaluating the Impact of Home-delivered Vegetables and Whole Grains on Diet of Food-insecure Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Nutrition Poor
Keywords: randomized intervention
home-delivery intervention
vegetables
whole grains
food insecurity
diet quality
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
Collaborators: name: Battery Powered
First posted: 2020-11-20
Enrollment: 68
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: vegetable consumption (servings/day) for child
timeFrame: 6 months
measure: whole grains consumption (ounce equivalents/day) for child
timeFrame: 6 months
measure: reported total cups of vegetables per day (for adult)
timeFrame: 6 months
Secondary outcomes:
measure: food security
timeFrame: 3 months
measure: food security
timeFrame: 6 months
measure: Body mass Index
timeFrame: 6 months
measure: Liking Scale (Vegetables)
timeFrame: 6 months
measure: Liking Scale (Whole grains)
timeFrame: 6 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
Study officials:
affiliation: Assistant Clinical Scientist
name: June Tester, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: