Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340093
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Diabetes Management Personal Trainer
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Diabetes Management Study
Status:
COMPLETED
Status Verified Date:
2007-03-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 1-year study will test the feasibility and effectiveness of a diabetes personal trainer in helping youth with diabetes manage their treatment It will examine how families with a diabetic child handle the responsibilities of managing diabetes and deal with the changes that come with managing the illness as the child grows up
Children between 11 and 16 years of age receiving treatment for diabetes type 1 at Johns Hopkins University Medical Center may be eligible for this study The children must have been diagnosed with diabetes at least 1 year before entering the study and must require insulin treatment One parent of each child will also participate
On entering the study each child and parent will be interviewed about various topics having to do with taking care of diabetes After the interview the children will be randomly assigned to one of two groups Group 1 will receive education information about diabetes management Group 2 will be enrolled in a program in which they meet with a diabetes personal trainer 6 to 7 times over 2 months for individualized instruction in planning and evaluating their diabetes care activities They will also keep in contact with their trainer by telephone
Children in Group 2 will be given a hand-held personal computer device in which they will keep a record of all diabetes-related activities for 3 days including insulin shots meals and snacks In addition they will wear an accelerometer a small device that keeps track of the amount of movement they make At the end of each of the 3 days the child will complete a 20- to 30-minute telephone interview reviewing the day They will have a tape-recorded interview about their experiences in taking care of diabetes Their meetings with the personal trainer also may be taped
Children in both groups will continue to see the doctor at the clinic as they normally would
At 2 and 6 months after starting the study children in both groups will complete a telephone interview about diabetes management At 12 months they will complete an in-person interview
Children between 11 and 16 years of age receiving treatment for diabetes type 1 at Johns Hopkins University Medical Center may be eligible for this study The children must have been diagnosed with diabetes at least 1 year before entering the study and must require insulin treatment One parent of each child will also participate
On entering the study each child and parent will be interviewed about various topics having to do with taking care of diabetes After the interview the children will be randomly assigned to one of two groups Group 1 will receive education information about diabetes management Group 2 will be enrolled in a program in which they meet with a diabetes personal trainer 6 to 7 times over 2 months for individualized instruction in planning and evaluating their diabetes care activities They will also keep in contact with their trainer by telephone
Children in Group 2 will be given a hand-held personal computer device in which they will keep a record of all diabetes-related activities for 3 days including insulin shots meals and snacks In addition they will wear an accelerometer a small device that keeps track of the amount of movement they make At the end of each of the 3 days the child will complete a 20- to 30-minute telephone interview reviewing the day They will have a tape-recorded interview about their experiences in taking care of diabetes Their meetings with the personal trainer also may be taped
Children in both groups will continue to see the doctor at the clinic as they normally would
At 2 and 6 months after starting the study children in both groups will complete a telephone interview about diabetes management At 12 months they will complete an in-person interview
Detailed Description:
Management of diabetes is a complex process involving the conduct of daily self-care activities problem-solving and decision-making Even in the most supportive environment adherence to the daily regimen is difficult Adherence is typically lowest among adolescents who are taking increasing amounts of responsibility for their diabetes management while still maturing cognitively and socially This pilot study will investigate the feasibility and effectiveness of a personal diabetes trainer in promoting adherence among early adolescents A sample of 120 youth ages 11 to 16 will be randomized to informational control or a diabetes personal trainer intervention Measures of adherence adjustment conflict attitudes and parental involvement will be obtained at baseline two months six months and one year following Measures of glycemic control will be abstracted from the medical records
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-CH-N290 | None | None | None |