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

Pediatric Obesity Clinical Trial

— NOURISH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116422
• Other study ID #: Pro00114248
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Steph Bryant, MPH, RD
• Phone: 919-620-5305
• Email: stephanie.l.bryant[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 in the form of weekly 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Food Insecurity
• Malnutrition
• Nutrition Poor
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Grocery intervention - unrestricted
Receives financial support in an unrestricted fashion (i.e., can use the money for whatever they need).
• 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.

Locations

Country	Name	City	State
United States	North Duke Street Pediatrics	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in Infant Dietary Quality	As measured by the USDA multipass food recall tool (ASA24).	baseline, 6 months, and 12 months
Other	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
Other	Perceived stress scale	As measured by a 10 item perceived stress scale for parents.	baseline, 6 months, and 12 months
Primary	Change in BMI (Body Mass Index)	At 12 months post-enrollment (24 months of age).	1 year