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

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ClinicalTrials.gov Identifier: NCT00948311
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : February 19, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Type 1 Diabetes Eating Disorder

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)?

Study Design

Study Type : Observational
Actual Enrollment : 279 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of an Instrument to Screen for Eating Disorder Symptoms in Persons With Type 1 Diabetes
Study Start Date : December 2008
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
International Diabetes Center patient with type 1 diabetes and an eating disorder.

Inclusion Criteria:

  • eating disorder
  • type 1 diabetes

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948311

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
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
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Papers have been published on the study.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Feeding and Eating Disorders
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Mental Disorders