Diabetes Management Personal Trainer

NCT00340093 | Completed Phase 1

• 2 other identifiers: 99990229002-CH-N290
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Keywords

Adherence; Behavioral Intervention; Adolescence; Self-Regulation; Behavioral Medicine; Diabetes

Interventions

Managing Diabetes BEHAVIORAL

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Mount Washington Pediatric Hospital

Baltimore, Maryland, United States

Location

Related Publications (1)

• Brown SA. Effects of educational interventions in diabetes care: a meta-analysis of findings. Nurs Res. 1988 Jul-Aug;37(4):223-30.

  PMID: 3293025 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Self-Control

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: August 23, 2002
• Study Completion: March 6, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-03-06

Locations

US (2)