Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06116422

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

12 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Duke Street Pediatrics

Durham, North Carolina, 27704, United States

Location status: Recruiting

Location contact

Steph Bryant

CONTACT

[email protected]

774-217-1997

Who can participate

Healthy volunteers accepted: Yes

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

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 ≥ 85%ile at current or most recent encounter (early-onset obesity) OR ≥ 20 pounds at 9 months old.
  • Caregiver speaks either English or Spanish as their primary language.
  • Infant was born as a singleton infant.

Exclusion:

  • Diagnosed with monogenic obesity.
  • Plans to move from the area in the next 12 months.
  • Parent is currently pregnant.

Treatment and study plan

Grocery intervention - unrestricted

Behavioral

Receives financial support in an unrestricted fashion (i.e., can use the money for whatever they need).

Grocery intervention - restricted

Behavioral

Receives financial support restricted to the purchase of items at a grocery store, and with monthly grocery shopping coaching from a trained nutrition expert.

Primary outcomes

  1. Change in BMI (Body Mass Index)

    Time frame: 1 year

    At 12 months post-enrollment (24 months of age).

Other outcomes

  1. Change in Food Security

    Time frame: baseline, 3, 6, 9 and 12 months

    As measured by an 18 item food insecurity screen to assess food insecurity levels.

  2. Change in Infant Dietary Quality

    Time frame: baseline, 6 months, and 12 months

    As measured by the USDA multipass food recall tool (ASA24).

  3. Change in Unmet social needs

    Time frame: baseline, 6 months, and 12 months

    Changes in social determinants of health affecting the family as measured by the HealthLeads questionnaire.

  4. Perceived stress scale

    Time frame: baseline, 6 months, and 12 months

    As measured by a 10 item perceived stress scale for parents.

Study contacts

Contact information is provided by the study sponsor or research team.

Janna Howard, MPH

CONTACT

[email protected]

919-620-4793

Steph Bryant, MPH, RD

CONTACT

[email protected]

919-620-5305

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study 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

Acronym: NOURISH

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 3, 2023
Registry last updated
Jan 16, 2026

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.

Published trials that share one or more normalized conditions with this study.