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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00999375 |
Purpose
Background:
Objectives:
Eligibility:
- Children 8 to 16 years of age who have been diagnosed with T1D for more than 12 months, and who use insulin injections to maintain normal blood glucose levels.
Design:
| Condition | Intervention | Phase |
|---|---|---|
|
Type I Diabetes |
Behavioral: Education Device: CGM Behavioral: Problem Solving Behavioral: Social Learning Behavioral: Behavior Modification |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF) |
| Estimated Enrollment: | 320 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group A |
Behavioral: Education
N/A
Device: CGM
Continuous Glucose Monitoring
Behavioral: Problem Solving
N/A
Behavioral: Social Learning
N/A
Behavioral: Behavior Modification
N/A
|
| Active Comparator: Group B |
Device: CGM
Continuous Glucose Monitoring
|
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 efficacy of such dietary changes in improving glycemic control and other diabetes-related health outcomes.
Eligibility| Ages Eligible for Study: | 8 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Insulin regimen
Joslin Clinic attendance
EXCLUSION CRITERIA:
Presence of co-morbid conditions (any of the following):
d. Significant mental illness defined by either:
Contacts and Locations| Contact: Tonja R. Nansel, Ph.D. | (301) 435-6937 | nanselt@mail.nih.gov |
| United States, Massachusetts | |
| Joslin Diabetes Center | Recruiting |
| Boston, Massachusetts, United States | |
| Principal Investigator: | Tonja R. Nansel, Ph.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
More Information
| Responsible Party: | Tonja R. Nansel, Ph.D./National Institute of Child Health and Human Development, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT00999375 History of Changes |
| Other Study ID Numbers: | 999909234, 09-CH-N234 |
| Study First Received: | October 20, 2009 |
| Last Updated: | March 22, 2012 |
| Health Authority: | United States: Federal Government |
|
Type 1 Diabetes Diet Behavioral Intervention Children Adolescents |
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |