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

NCT04639687 | Completed

• 1 other identifier: 2018-062
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Insecurity; Nutrition Poor

Keywords

randomized intervention; home-delivery intervention; vegetables; whole grains; food insecurity; diet quality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• food security

  3 months

• food security

  6 months

• Body mass Index

  6 months

• Liking Scale (Vegetables)

  6 months

• Liking Scale (Whole grains)

  6 months

Study Arms (2)

Immediate intervention

EXPERIMENTAL

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

Wait list control (delayed intervention)

OTHER

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

Interventions

Food as Medicine Delivery BEHAVIORAL

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

Immediate intervention; Wait list control (delayed intervention)

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• Battery Powered: collaborator

Study Sites (1)

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Food

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• June Tester, MD, MPH

  Assistant Clinical Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: November 20, 2020
• Study Start: April 3, 2019
• Primary Completion: November 13, 2020
• Study Completion: January 27, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)