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

Food Insecurity Clinical Trial

— FAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04639687
• Other study ID #: 2018-062
• Status: Completed
• Phase: N/A
• Start date: April 3, 2019
• Est. completion date: January 27, 2021

Study information

• Verified date: May 2021
• Source: UCSF Benioff Children's Hospital Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 27, 2021
• Est. primary completion date: November 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Food Insecurity
• Malnutrition
• Nutrition Poor

Intervention

Behavioral:
• Food as Medicine Delivery
12 consecutive weeks of home-delivered vegetables plus whole grain foods along with weekly text containing educational video

Locations

Country	Name	City	State
United States	UCSF Benioff Children's Hospital Oakland	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
UCSF Benioff Children's Hospital Oakland	Battery Powered

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vegetable consumption (servings/day) for child	24-diet diet recall (total vegetables)	6 months
Primary	whole grains consumption (ounce equivalents/day) for child	24-diet diet recall (total vegetables)	6 months
Primary	reported total cups of vegetables per day (for adult)	Fruit and Vegetable checklist	6 months
Secondary	food security	Core food security module (up to 18 questions)	3 months
Secondary	food security	Core food security module (up to 18 questions)	6 months
Secondary	Body mass Index	Body mass index, calculated	6 months
Secondary	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
Secondary	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