Pediatric ObesityNOURISHNCT06116422
Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health
A study testing Grocery intervention - unrestricted and Grocery intervention - restricted in people with Pediatric Obesity and Food Insecurity, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Food Insecurity, Nutrition, Healthy
- What is being tested?
- Grocery intervention - unrestricted and Grocery intervention - restricted
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Diagnosed with monogenic obesity.
- Plans to move from the area in the next 12 months.
- Parent is currently pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
North Duke Street Pediatrics
Durham, North Carolina, 27704
Steph Bryant, 774-217-1997, stephanie.l.bryant@duke.edu
About this study
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
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.
- Conditions
- Pediatric Obesity, Food Insecurity, Nutrition, Healthy, Nutrition Poor
- Being tested
- Grocery intervention - unrestricted, Grocery intervention - restricted
- Medical subject headings
- Pediatric Obesity, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grocery intervention - unrestrictedBehavioural
Receives financial support in an unrestricted fashion (i.e., can use the money for whatever they need).
Grocery intervention - restrictedBehavioural
Receives financial support restricted to the purchase of items at a grocery store, and with monthly grocery shopping coaching from a trained nutrition expert.
| Study group | Role | What they receive |
|---|---|---|
| Cash Benefit Group | Active comparator | 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. Receives: Behavioral: Grocery intervention - unrestricted |
| Grocery Benefit Group | Active comparator | 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. Receives: Behavioral: Grocery intervention - restricted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI (Body Mass Index)
At 12 months post-enrollment (24 months of age).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start30 May 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative effectiveness study.
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116422
- Sponsor's protocol ID
- Pro00114248
- Acronym
- NOURISH
- Status last verified
- Jan 2026
- First submitted
- 24 Oct 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06116422
- Acronym / sponsor ID
- NOURISH / Pro00114248
- Conditions
- Pediatric Obesity, Food Insecurity, Nutrition, Healthy, Nutrition Poor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative effectiveness study.
| Arm | Type | Receives |
|---|---|---|
| Cash Benefit Group | Active comparator | Behavioral: Grocery intervention - unrestrictedProvides 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. |
| Grocery Benefit Group | Active comparator | Behavioral: Grocery intervention - restrictedProvides 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. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Diagnosed with monogenic obesity.
- Plans to move from the area in the next 12 months.
- Parent is currently pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grocery intervention - unrestrictedReceives financial support in an unrestricted fashion (i.e., can use the money for whatever they need). | Behavioural | Cash Benefit Group |
| Grocery intervention - restrictedReceives financial support restricted to the purchase of items at a grocery store, and with monthly grocery shopping coaching from a trained nutrition expert. | Behavioural | Grocery Benefit Group |
Primary outcome
Change in BMI (Body Mass Index)
Time frame: 1 year
At 12 months post-enrollment (24 months of age).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grocery intervention - unrestricted and Grocery intervention - restricted in people with Pediatric Obesity and Food Insecurity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steph Bryant, MPH, RD (919-620-5305, stephanie.l.bryant@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI (Body Mass Index) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.