An interventional study of Food as Medicine Delivery in Food Insecurity and Nutrition Poor, sponsored by UCSF Benioff Children's Hospital Oakland. Completed at 1 site in United States. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-28.
Sponsored by UCSF Benioff Children's Hospital Oakland · Not applicable, Interventional, and Treatment
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.
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.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's enrollment of 68 is below the median of 118 across 843 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →UCSF Benioff Children's Hospital Oakland is the lead sponsor of 55 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
vegetable consumption (servings/day) for child
24-diet diet recall (total vegetables)
Time frame: 6 months
whole grains consumption (ounce equivalents/day) for child
24-diet diet recall (total vegetables)
Time frame: 6 months
reported total cups of vegetables per day (for adult)
Fruit and Vegetable checklist
Time frame: 6 months
food security
Core food security module (up to 18 questions)
Time frame: 3 months
food security
Core food security module (up to 18 questions)
Time frame: 6 months
Body mass Index
Body mass index, calculated
Time frame: 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')
Time frame: 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')
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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UCSF Benioff Children's Hospital Oakland