Develop and Validate a Self-Administered Instrument That Will Screen for Eating Disorder Symptoms in Persons Aged 12 and Older With Type 1 Diabetes.

This study has been completed.
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
Park Nicollet Eating Disorder Institute
Park Nicollet Foundation
Information provided by (Responsible Party):
HealthPartners Institute
ClinicalTrials.gov Identifier:
NCT00948311
First received: July 27, 2009
Last updated: February 17, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to develop and validate a survey instrument to be used by persons with type 1 diabetes aged 12 and older to screen for an eating disorder.

Condition
Type 1 Diabetes
Eating Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of an Instrument to Screen for Eating Disorder Symptoms in Persons With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute:

Enrollment: 279
Study Start Date: December 2008
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Phase 1 - Develop an initial instrument and start to establish content validity. What do dually diagnosed patients believe are the most important, relevant, and significantly contributing constructs that we should measure in order to capture those individuals with type 1 diabetes who may exhibit symptoms of an eating disorder? What individual items will best measure these constructs?

Phase 2 - Conduct individual interviews for cognitive testing of our instrument and further examine its content validity. How well do the individual items included in our instrument capture eating disorder symptoms in patients with type 1 diabetes? Do these items accurately capture the information we seek to collect? What symptoms have we not considered? How readable and understandable are our questions?

Phase 3 - Explore the internal consistency reliability and construct validity of our instrument. Do the items in our instrument accurately capture the constructs we wish to measure? Do similar items "hang together" in a manner that is clinically and theoretically meaningful?

Phase 4 - Address convergent and discriminant validity as well as test-retest reliability. Does our instrument demonstrate appropriate convergent and divergent validity as well as test-retest reliability? Does our instrument capture eating disorder symptoms among persons with diabetes? Is our instrument more specific to the population of individuals with diabetes than traditional eating disorder instruments (i.e., does our instrument capture more information and give a more accurate presentation than the other instruments)?

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
International Diabetes Center patient with type 1 diabetes and an eating disorder.
Criteria

Inclusion Criteria:

  • eating disorder
  • type 1 diabetes

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948311

Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
HealthPartners Institute
International Diabetes Center at Park Nicollet
Park Nicollet Eating Disorder Institute
Park Nicollet Foundation
Investigators
Principal Investigator: Margaret Powers, PhD International Diabetes Center at Park Nicollet
  More Information

Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT00948311     History of Changes
Other Study ID Numbers: 03798-08-A 
Study First Received: July 27, 2009
Last Updated: February 17, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 25, 2016