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Completed

NCT Number: NCT04639687

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

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.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food as Medicine Delivery

Behavioral

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

Primary outcomes

  1. vegetable consumption (servings/day) for child

    Time frame: 6 months

    24-diet diet recall (total vegetables)

  2. whole grains consumption (ounce equivalents/day) for child

    Time frame: 6 months

    24-diet diet recall (total vegetables)

  3. reported total cups of vegetables per day (for adult)

    Time frame: 6 months

    Fruit and Vegetable checklist

Secondary outcomes

  1. food security

    Time frame: 3 months

    Core food security module (up to 18 questions)

  2. food security

    Time frame: 6 months

    Core food security module (up to 18 questions)

  3. Body mass Index

    Time frame: 6 months

    Body mass index, calculated

  4. Liking Scale (Vegetables)

    Time frame: 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')

  5. Liking Scale (Whole grains)

    Time frame: 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')

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Collaborators

  • Battery Powered

Registry information

Acronym: FAM

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Nov 20, 2020
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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