Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health (NOURISH)

Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health: A Multi-disciplinary Approach for Study and Mitigation of Food Insecurity and Obesity

Food insecurity is associated with obesity in children, and childhood obesity leads to long term health consequences. While existing research shows that food benefit programs reduce food insecurity, little is known about the mediating factors between food benefit programs and child health. The purpose of this study is to understand if the resolution of food insecurity in young children with early onset obesity can improve body mass index (BMI) over one year, and if so, by what mechanisms. The investigators will conduct a randomized comparative effectiveness study among infants (n=228) aged 12 months at risk for food insecurity and deliver two different food security interventions. Both will provide families with $50/week for one year of study enrollment. The first group will receive this as an unrestricted cash benefit ("cash benefit group") and the second group will receive this as a benefit limited to grocery purchases with the support of a trained nutrition expert to guide healthy grocery purchasing ("grocery benefit group"). The investigators will also construct a contemporary comparison cohort of infants meeting the inclusion/exclusion criteria from the electronic health record, using propensity score matching to allow comparisons between both intervention groups and usual care. The primary endpoint is difference in BMI at 12 months post-enrollment (24 months of age). Secondary outcomes include measures of nutrition, food security, electronic health record data related to general child health, and other factors related to parental stress and unmet social needs. Patients will have the opportunity to participate in post-study interviews to report on intervention satisfaction, and facilitators and barriers of infant feeding. Data analysis will be conducted by a trained statistician (Duke Biostatistics, Epidemiology, and Research Design; BERD) and will employ a two-means test for a repeated-measures design. The benefits to participants outweigh the minimal risks of loss of privacy, and confidential information will be managed carefully to minimize this risk.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Obesity; Food Insecurity; Nutrition Poor; Nutrition, Healthy
• Intervention / Treatment: Behavioral: Grocery intervention - unrestricted; Behavioral: Grocery intervention - restricted

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janna Howard, MPH; Phone Number: 919-620-4793; Email: janna.howard@duke.edu
• Study Contact Backup: Name: Steph Bryant, MPH, RD; Phone Number: 919-620-5305; Email: stephanie.l.bryant@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion:

• Aged 9-12 months and their primary caregiver "parent".
• Medicaid and WIC-eligible (proxy for "at risk for food insecurity")
• World Health Organization BMI ≥ 95%ile at current or most recent encounter (early-onset obesity)
• Caregiver speaks either English or Spanish as their primary language.
• Infant was born as a singleton infant at ≥ 35 weeks gestational age with birth weight ≥ 3% per the sex-specific WHO growth standard (also could use our criteria for SGA, which is <10% for Olsen reference)

Exclusion:

• Diagnosed with monogenic obesity.
• Diagnosis affecting growth or feeding (e.g., congenital heart disease, cleft lip/palate, inborn errors of metabolism, malabsorption, Prader-Willi disease, etc.)
• Current enrollment of a household member in Healthy Lifestyles, adult obesity treatment program, or active enrollment in a nutrition or obesity-related intervention
• Plans to move from the area in the next 12 months.
• Parent is currently pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cash Benefit Group; Provides financial support weekly, in the form of an unrestricted cash benefit. The investigators will partner with Held to provide the card to participants, load the card with $50/week for the 12 months of enrollment, and view the purchases at the vendor level using an existing dashboard Held maintains. Participants will also receive a monthly nutrition guidance brochure tailored to the infant's developmental stage.	Behavioral: Grocery intervention - unrestricted; Receives financial support in an unrestricted fashion (i.e., can use the money for whatever they need).
Active Comparator: Grocery Benefit Group; Provides financial support weekly in the form of a grocery benefit. The investigators will enroll participants in the Food Lion MVP program, linking the account to a Duke email address. The study team will work with the participants to order $50 worth of groceries from Food Lion, for the participants to pick up from the store. Groceries will be ordered weekly for the 12 months of enrollment and coordinators will have access to view items purchased at Food Lion by each participant.	Behavioral: Grocery intervention - restricted; Receives financial support restricted to the purchase of items at a grocery store, and with monthly grocery shopping coaching from a trained nutrition expert.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI (Body Mass Index)	At 12 months post-enrollment (24 months of age).	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Food Security	As measured by an 18 item food insecurity screen to assess food insecurity levels.	baseline, 3, 6, 9 and 12 months
Change in Infant Dietary Quality	As measured by the USDA multipass food recall tool (ASA24).	baseline, 6 months, and 12 months
Change in Unmet social needs	Changes in social determinants of health affecting the family as measured by the HealthLeads questionnaire.	baseline, 6 months, and 12 months
Perceived stress scale	As measured by a 10 item perceived stress scale for parents.	baseline, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Malnutrition
• Other Study ID Numbers: Pro00114248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No