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NCT00999375 · ClinicalTrials.gov registry record · Phase 2
Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF)
A Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 293
- Enrollment target
NCT00999375: Completed Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00999375 is a Phase 2 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 293 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00999375, a Phase 2 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 293 participants
- Enrollment target
Study 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 allows the body to use glucose from food. Children with T1D manage their diabetes by taking insulin, monitoring their blood glucose levels, and watching their diet, including carbohydrates. * Carbohydrates come from many different kinds of food, and recent research has shown that different foods have a different effect on the level of glucose in the blood. In general, whole, unprocessed foods (e.g., fruits, vegetables, whole grains, legumes) have a lower glycemic index (GI), which means that they cause smaller, more sustained blood sugar levels. Additionally, these foods are rich in nutrients. Nutrient-poor carbohydrates come from foods made with refined grains and sugars, such as breads, crackers, and breakfast cereals; they general cause a more rapid increases in blood sugar (i.e., a high GI). Lower GI diets may help people with T1D manage their blood glucose levels more easily. Objectives: * To determine the utility of a whole foods, low GI diet in the management of T1D. * To determine the utility of a behavioral intervention to promote healthful family dietary behaviors, including eating more fruits, vegetables, whole grains, and legumes, and fewer refined carbohydrates. * To determine how the dietary intervention affects quality of life, satisfaction with the diet, and risk for problem eating behaviors. 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: * Families will be divided into two groups: an intervention group that will participate in intensive dietary intervention and continuous glucose monitoring (CGM) and a control group that will not have the dietary intervention but will have CGM and scheduled contacts with study s
Interventions
- BEHAVIORAL Education
- BEHAVIORAL Problem Solving
- BEHAVIORAL Social Learning
- BEHAVIORAL Behavior Modification
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 293 participants |
| Start Date | 2009-09-18 |
| Est. Completion | 2013-11-27 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00999375 record still lists
NCT00999375 is an interventional study that assigns participants to a tested intervention. The registered 293 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (120% higher).
The record links to 0 conditions, and to 4 interventions - of which Education is the first listed.
NCT00999375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00999375 about?
NCT00999375 is a clinical study titled "Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF)". 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 allows the body to use glucose from food. Children with T1D manage their diabetes by taking insulin...
What is the current status of trial NCT00999375?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 293 participants. The study started on 2009-09-18. Estimated completion is 2013-11-27.
What interventions are being tested in trial NCT00999375?
The interventions under investigation include: Education (BEHAVIORAL), Problem Solving (BEHAVIORAL), Social Learning (BEHAVIORAL), Behavior Modification (BEHAVIORAL).
Who is sponsoring clinical trial NCT00999375?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00999375's enrollment target sits among peer trials
293 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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