Diabetes Management Personal Trainer
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): Managing Diabetes
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: Adherence; Behavioral Intervention; Adolescence; Self-Regulation; Behavioral Medicine; Diabetes