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

Sponsor

UCSF Benioff Children's Hospital Oakland (Other)

Overall Status

Completed

CT.gov ID

NCT04639687

Collaborator

Battery Powered (Other)

Enrollment

Location

Arms

21.8

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Food Insecurity Nutrition Poor	Behavioral: Food as Medicine Delivery	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 3, 2019

Actual Primary Completion Date :

Nov 13, 2020

Actual Study Completion Date :

Jan 27, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Immediate intervention

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

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

Other: Wait list control (delayed intervention)

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

Outcome Measures

Primary Outcome Measures

vegetable consumption (servings/day) for child [6 months]
24-diet diet recall (total vegetables)
whole grains consumption (ounce equivalents/day) for child [6 months]
24-diet diet recall (total vegetables)
reported total cups of vegetables per day (for adult) [6 months]
Fruit and Vegetable checklist

Secondary Outcome Measures

food security [3 months]
Core food security module (up to 18 questions)
food security [6 months]
Core food security module (up to 18 questions)
Body mass Index [6 months]
Body mass index, calculated
Liking Scale (Vegetables) [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')
Liking Scale (Whole grains) [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')

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts 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