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

Primary Purpose

Food Insecurity, Nutrition Poor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food as Medicine Delivery
Sponsored by
UCSF Benioff Children's Hospital Oakland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Insecurity focused on measuring randomized intervention, home-delivery intervention, vegetables, whole grains, food insecurity, diet quality

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCSF Benioff Children's Hospital Oakland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate intervention

Wait list control (delayed intervention)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

food security
Core food security module (up to 18 questions)
food security
Core food security module (up to 18 questions)
Body mass Index
Body mass index, calculated
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')
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')

Full Information

First Posted
April 29, 2019
Last Updated
May 26, 2021
Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
Battery Powered
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1. Study Identification

Unique Protocol Identification Number
NCT04639687
Brief Title
Food as Medicine: Evaluating the Impact of Home-delivered Vegetables and Whole Grains on Diet of Food-insecure Families
Acronym
FAM
Official Title
Food as Medicine: Evaluating the Impact of Home-delivered Vegetables and Whole Grains on Diet of Food-insecure Families
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
November 13, 2020 (Actual)
Study Completion Date
January 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
Battery Powered

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Insecurity, Nutrition Poor
Keywords
randomized intervention, home-delivery intervention, vegetables, whole grains, food insecurity, diet quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Wait list control (delayed intervention)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Food as Medicine Delivery
Intervention Description
12 consecutive weeks of home-delivered vegetables plus whole grain foods along with weekly text containing educational video
Primary Outcome Measure Information:
Title
vegetable consumption (servings/day) for child
Description
24-diet diet recall (total vegetables)
Time Frame
6 months
Title
whole grains consumption (ounce equivalents/day) for child
Description
24-diet diet recall (total vegetables)
Time Frame
6 months
Title
reported total cups of vegetables per day (for adult)
Description
Fruit and Vegetable checklist
Time Frame
6 months
Secondary Outcome Measure Information:
Title
food security
Description
Core food security module (up to 18 questions)
Time Frame
3 months
Title
food security
Description
Core food security module (up to 18 questions)
Time Frame
6 months
Title
Body mass Index
Description
Body mass index, calculated
Time Frame
6 months
Title
Liking Scale (Vegetables)
Description
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
Title
Liking Scale (Whole grains)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June Tester, MD, MPH
Organizational Affiliation
Assistant Clinical Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Benioff Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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