UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609, United States
NCT Number: NCT04639687
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.
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Notify Me10 year and older
All sexes
Interventional
Not applicable
Oakland, California, 94609, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12 consecutive weeks of home-delivered vegetables plus whole grain foods along with weekly text containing educational video
Time frame: 6 months
24-diet diet recall (total vegetables)
Time frame: 6 months
24-diet diet recall (total vegetables)
Time frame: 6 months
Fruit and Vegetable checklist
Time frame: 3 months
Core food security module (up to 18 questions)
Time frame: 6 months
Core food security module (up to 18 questions)
Time frame: 6 months
Body mass index, calculated
Time frame: 6 months
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')
Time frame: 6 months
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')
UCSF Benioff Children's Hospital Oakland
Other
Acronym: FAM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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