Diabetes Management Personal Trainer

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00340093
First received: June 19, 2006
Last updated: March 7, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Diabetes
Behavioral: Managing Diabetes
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: The Diabetes Management Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 0
Study Start Date: August 2002
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Inclusion criteria include 1) youth diagnosed with Type 1 diabetes for a minimum of 1 year and requiring insulin treatment, 2) youth age 11-16, and 3) both youth and a parent with whom the youth lives most of the time and has primary responsibility for child's health willing to participate.

EXCLUSION CRITERIA:

Exclusion criteria include 1) comorbid chronic illness requiring daily medical management or psychiatric diagnosis or 2) youth or parent non-English speaking/writing.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00340093

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Mount Washington Pediatric Hospital
Baltimore, Maryland, United States
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00340093     History of Changes
Other Study ID Numbers: 999902290, 02-CH-N290
Study First Received: June 19, 2006
Last Updated: March 7, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Adherence
Behavioral Intervention
Adolescence
Self-Regulation
Behavioral Medicine
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 20, 2014