Trial Radar IA | ||
|---|---|---|
Lo studio clinico NCT00999375 per Type I Diabetes è completato. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF) Fase II 293 Dieta
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 man...
Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF)
- 999909234
- 09-CH-N234
Diet
Behavioral Intervention
Children
Adolescents
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleGroup A | Educazione Problem Solving Social Learning Behavior Modification |
Comparatore attivoGroup B | Educazione |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in glycemic control, change in dietary intake | 18 months |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in social cognitive mediators of behavior; change in psychosocial status; change in body composition, lipids, oxidative stress, and inflammation |
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
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Massachusetts