Health TrialsbyHealthPanel

Food Prescription Among Youth With Type 1 Diabetes

ConditionType 1 Diabetes (T1D)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-15
SponsorBaylor College of Medicine

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Physical/mental disease or condition that may conflict with study protocol

Celiac Disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Healthy Eating Program

    Behavioral

    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.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Standard diabetes careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Intervention Acceptability: Acceptability of Intervention Measure

Acceptability of Intervention Measure (scores range from 4-20 with higher scores indicating higher acceptability of the intervention)

Time frame
Immediately Post-Intervention
2

Study Enrollment Rate

Enrollment rate calculated from data obtained from recruitment logs

Time frame
Pre-Randomization
3

Study Attrition Rate

Study attrition will be calculated from study logs

Time frame
6 months
4

Family behavioral intervention sessions completed by families

Percentage of sessions completed by families will be determined from study logs

Time frame
6 months

Secondary outcomes

1

Hemoglobin A1C

Hemoglobin A1C from medical record

Time frame
Change from baseline at 6 months
2

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)

Time frame
Change from baseline to 6 months
3

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)

Time frame
Change from baseline at 6 months
4

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)

Time frame
Change from baseline at 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: