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| Sponsor: | Park Nicollet Institute |
|---|---|
| Collaborators: |
International Diabetes Center at Park Nicollet Park Nicollet Eating Disorder Institute Park Nicollet Foundation |
| Information provided by (Responsible Party): | Park Nicollet Institute |
| ClinicalTrials.gov Identifier: | NCT00948311 |
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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2008 |
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 |
International Diabetes Center patient with type 1 diabetes and an eating disorder.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Margaret Powers, PhD | 952-993-2793 | powerma@parknicollet.com |
| United States, Minnesota | |
| International Diabetes Center | Recruiting |
| Minneapolis, Minnesota, United States, 55416 | |
| Principal Investigator: Margaret Powers, PhD | |
| International Diabetes Center | Recruiting |
| Minneapolis, Minnesota, United States, 55416 | |
| Contact: Margaret Powers, PhD 952-993-2793 powerma@parknicollet.com | |
| Principal Investigator: | Margaret Powers, PhD | International Diabetes Center at Park Nicollet |
More Information
| Responsible Party: | Park Nicollet Institute |
| ClinicalTrials.gov Identifier: | NCT00948311 History of Changes |
| Other Study ID Numbers: | 03798-08-A |
| Study First Received: | July 27, 2009 |
| Last Updated: | November 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Eating Disorders Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases Mental Disorders |