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

NCT ID: NCT00948311

Last Updated: 2016-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

279 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Eating Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* eating disorder
* type 1 diabetes

Exclusion Criteria

* none
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

International Diabetes Center at Park Nicollet

OTHER

Sponsor Role collaborator

Park Nicollet Eating Disorder Institute

OTHER

Sponsor Role collaborator

Park Nicollet Foundation

OTHER

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Margaret Powers, PhD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center at Park Nicollet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

International Diabetes Center

Minneapolis, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27932687 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26124085 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

03798-08-A

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Liraglutide in Type 1 Diabetes
NCT01612468 COMPLETED PHASE4
Inpatient Diabetes on Corticosteroids
NCT01970241 COMPLETED PHASE4
Liraglutide in Type 1 Diabetes
NCT01722240 COMPLETED PHASE3
Glucose Variability in Subclinical Hypertrophy
NCT02748434 ACTIVE_NOT_RECRUITING NA