NCT00326573

Brief Summary

The management of diabetes in adolescence presents significant difficulties due to psychological and physiological factors. Blood glucose control deteriorates in this age group and poor management threatens long-term health. Motivational Interviewing, a psychological intervention designed to facilitate behaviour change, has recently been used with a small group of teenagers, producing improved blood glucose control. To establish the impact of this intervention and its key components, we plan to compare the outcome in several clinics over a longer period of time in a larger number of adolescents selected at random to undergo motivational interviewing or to act as a control group. If successful this approach has potential to be incorporated into the routine clinical care of adolescents with diabetes.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 diabetes-mellitus

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_1 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
Last Updated

May 17, 2006

Status Verified

October 1, 2004

First QC Date

May 15, 2006

Last Update Submit

May 15, 2006

Conditions

Diabetes Mellitus

Keywords

DiabetesTeenagersMotivational Interviewing

Outcome Measures

Primary Outcomes (1)

  • HbA1C at 6 months, end of intervention and one year follow up

Secondary Outcomes (3)

  • well being at baseline and end of one year intervention

  • family behaviour at baseline and end of one year intervention

  • quality of life at baseline and end of one year intervention

Interventions

Motivational InterviewingBEHAVIORAL

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 14-17
  • With type 1 diabetes
  • Attending diabetes clinic in participating centre

You may not qualify if:

  • Less than one year since diagnosis
  • Learning disabilities
  • Other medical conditions affecting diabetes management
  • Accommodated by social services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Child Health, UHW

Cardiff, South Glamorgan, CF14 4XN, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sue Channon, D Clin Psych

    Cardiff and Vale University Health Board

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 17, 2006

Study Start

October 1, 2001

Study Completion

June 1, 2005

Last Updated

May 17, 2006

Record last verified: 2004-10

Locations

GB(1)