Clinical trial NCT00948311: Develop and Validate a Self-Administered Instrument That Will Screen for Eating Disorder Symptoms in Persons Aged 12 and Older With Type 1 Diabetes.
Official title: Development of an Instrument to Screen for Eating Disorder Symptoms in Persons With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Eating Disorder
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: International Diabetes Center at Park Nicollet
name: Park Nicollet Eating Disorder Institute
name: Park Nicollet Foundation
First posted: 2009-07-29
Enrollment: 279
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: International Diabetes Center patient with type 1 diabetes and an eating disorder.

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.

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 criteria: Inclusion Criteria:

* eating disorder
* type 1 diabetes

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Margaret Powers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Powers MA, Richter SA, Ackard DM, Craft C. Diabetes Distress Among Persons With Type 1 Diabetes. Diabetes Educ. 2017 Feb;43(1):105-113. doi: 10.1177/0145721716680888. Epub 2016 Dec 8.
citation: Powers MA, Richter SA, Ackard DM, Cronemeyer C. Eating disorders in persons with type 1 diabetes: A focus group investigation of early eating disorder risk. J Health Psychol. 2016 Dec;21(12):2966-2976. doi: 10.1177/1359105315589799. Epub 2015 Jun 29.