Status:
COMPLETED
Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF)
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Type I Diabetes
Eligibility:
All Genders
8-17 years
Phase:
PHASE2
Brief Summary
Background: * Type 1 diabetes (T1D) is a common chronic disease in children, occurring in approximately 1 of every 400 to 600 children. Children with T1D are unable to produce insulin, a hormone that...
Detailed Description
This protocol describes a randomized controlled trial to promote consumption of carbohydrates from nutrient-dense whole foods among children and adolescents with type 1 diabetes and to determine the e...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Child age 8.0-16.9 years
- T1D: classical presentation and/or antibody positivity
- Diabetes duration greater than or equal to 12 months
- Daily insulin dose greater than or equal to 0.5 units/kilogram
- Hemoglobin A1c greater than or equal to 7.0% and less than or equal to 9.5%
- Insulin regimen
- a. Greater than or equal to 3 injections daily, OR
- b. Continuous subcutaneous insulin infusion (insulin pump) (CSII)
- Blood glucose monitoring frequency: Greater than or equal to 3 checks daily
- Stable living situation (guardian and address) for greater than or equal to 6 months
- Joslin Clinic attendance
- a. At least one Joslin Clinic visit in last year, AND
- b. Anticipated care at Joslin Clinic for duration of study
- EXCLUSION CRITERIA:
- Daily use of premixed insulin
- Transition to CSII (insulin pump) therapy in last 3 months
- Continuous glucose monitoring use in last 3 months
- Participation in a different intervention study in the last 6 months
- Presence of co-morbid conditions (any of the following):
- a. Celiac disease, inflammatory bowel disease, or other significant gastrointestinal condition
- b. Systemic glucocorticoid use (cumulative 1 month during last year)
- c. Significant multiple food allergies
- d. Significant mental illness defined by either:
- 1\. Major psychiatric disorder (e.g., eating disorder, major psychoses), OR
- 2\. Inpatient psychiatric admission during last 6 months
- Significant medical or psychiatric illness in caregiver that would prevent active participation in the study
- Intent to enroll in another intervention study during the course of this study
Exclusion
Key Trial Info
Start Date :
September 18 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2013
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT00999375
Start Date
September 18 2009
End Date
November 27 2013
Last Update
November 29 2019
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States