Type 1 Diabetes (T1D)NOURISHNCT07860229
Food Prescription Among Youth With Type 1 Diabetes
A study testing Healthy Eating Program in people with Type 1 Diabetes (T1D), run by Baylor College of Medicine.
Trial summary
The purpose of this study is to assess the feasibility and preliminary outcomes of a healthy eating program that consists of Food Rx combined with an evidence-based healthy eating family behavioral intervention refined for delivery by CHWs for families of youth with type 1 diabetes (ages 10-15 years) from food… Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Healthy Eating Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2028
- Phase
- Interventional
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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinic-integrated Hunger Vital Sign™ screener questionnaire indicating food insecurity
- Ages 10-15 years
- T1D as defined by the American Diabetes Association criteria
- T1D disease duration >1 year
- Having a positive food insecurity screen documented in the EPIC medical record within the past 12 months
- Fluent in English or Spanish
- Not planning to leave the geographic area during the study
Who cannot join
- Physical/mental disease or condition that may conflict with study protocol
- Celiac Disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Pilot and Feasibility Evaluation of Food Prescription Among Youth With Type 1 Diabetes
The purpose of this study is to assess the feasibility and preliminary outcomes of a healthy eating program that consists of Food Rx combined with an evidence-based healthy eating family behavioral intervention refined for delivery by CHWs for families of youth with type 1 diabetes (ages 10-15 years) from food insecure households. The healthy eating program (Food Rx + healthy eating family behavioral intervention) will be evaluated in a randomized pilot trial where families will be randomized 1:1 (intervention: standard diabetes care).
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Healthy Eating Program
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Eating ProgramBehavioural
Children with T1D and their parent will participate in 9 virtual behavioral intervention sessions and will receive access to redeem food twice per month through a community-based Food Rx program during the 6-month intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Healthy Eating Program |
| Standard diabetes care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability: Acceptability of Intervention Measure
Acceptability of Intervention Measure (scores range from 4-20 with higher scores indicating higher acceptability of the intervention)
Measured: Immediately Post-Intervention
Study Enrollment Rate
Enrollment rate calculated from data obtained from recruitment logs
Measured: Pre-Randomization
Study Attrition Rate
Study attrition will be calculated from study logs
Measured: 6 months
Family behavioral intervention sessions completed by families
Percentage of sessions completed by families will be determined from study logs
Measured: 6 months
Food redemptions completed per family
Percentage of food redemptions completed by families will be determined from study logs
Measured: 6 months
Secondary outcomes (8)
Hemoglobin A1C
Hemoglobin A1C from medical record
Measured: Change from baseline at 6 months
Change in Food Security: USDA Household Food Security Questionnaire
USDA Household Food Security Questionnaire (scores range from 0-100 with higher scores indicating greater food insecurity)
Measured: Change from baseline to 6 months
Change in Nutrition Security: Center for Nutrition and Health Impact's Nutrition Secruity Module
Center for Nutrition and Health Impact's Nutrition Secruity Module (scores range from 0-4 with higher scores indicating a greater degree of houshold nutrition security)
Measured: Change from baseline at 6 months
Change in Diabetes Distress: Problem Areas in Diabetes Scale
Problem Areas in Diabetes Scale (scores range from 0-72 with higher scores indicating less emotional burden)
Measured: Change from baseline at 6 months
Change in Fear of Hypoglycemia: Hypoglycemia Fear Survey
Hypoglycemia Fear Survey (scores range from 0 to 104 with higher scores indicating a higher levels of fear of hypoglycemia)
Measured: Change from baseline at 6 months
Change in Diabetes Self-Management: The Diabetes Self-Management Questionnaire)
The Diabetes Self-Management Questionnaire (scores range from 0-36 with higher scores indicating higher levels of adherence to diabetes management behaviors)
Measured: Change from baseline at 6 months
Change in Diabetes Self-Efficacy: Self-Efficacy for Diabetes Management Questionnaire)
Self-Efficacy for Diabetes Management Questionnaire (Scores range from 8-40 with higher scores indicating higher self-efficacy)
Measured: Change from baseline at 6 months
Change in Dietary Intake: Automated Self-Administered 24-hour Dietary Assessment Tool
Automated Self-Administered 24-hour Dietary Assessment Tool: Macronutrient Intake
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Butler, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860229
- Sponsor's protocol ID
- H-57200
- Other IDs
- R01DK140212
- Acronym
- NOURISH
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No