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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Food Insecurity, Nutrition Poor

Intervention / Treatment
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* Behavioral: Food as Medicine Delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate intervention<br>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<br>* 12 consecutive weeks of home-delivered vegetables plus whole grain foods along with weekly text containing educational video<br>|
| Other: Wait list control (delayed intervention)<br>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<br>* 12 consecutive weeks of home-delivered vegetables plus whole grain foods along with weekly text containing educational video<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized intervention, home-delivery intervention, vegetables, whole grains, food insecurity, diet quality