- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00818142
Support Group Surveys for Individuals Who Have Type 1 Diabetes and an Eating Disorder
November 30, 2015 updated by: HealthPartners Institute
We propose to conduct a monthly group of persons with type 1 diabetes who also withhold insulin.
Subjects will be asked to complete a 2-page survey (check-in sheet) at the beginning of each session and a 5-page survey (Diabetes and Eating Disorders Survey) on their first session and at their last session of their group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
16
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55416
- Park Nicollet Eating Disorder Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Individuals diagnosed with type 1 diabetes and an eating disorder who manipulate their insulin will be considered to join the ED/DM Recovery Group.
Description
Inclusion Criteria:
- Have an eating disorder
- Have type 1 diabetes
- Withhold their insulin
- 18 years or older
- Actively being treated at EDI
- Committed to at least one appointment each month with each member of their individual EDI team (RD, CDE or RN, CDE; LP; and MD)
- Approval of participation by EDI/DM team (RD; RN; LP; MD)
- Able to attend 66% of group sessions
Exclusion Criteria:
- Psychologically not ready for this group therapy
- Have additional eating disorder issues that would make attendance in this group inappropriate
- Not committed to continuing treatment at PN's EDI
- Not being actively treated at PN's EDI
- Has type 2 diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
eating disorder, type 1 diabetes
Individuals diagnosed with type 1 diabetes and an eating disorder who withhold their insulin.
|
The ED/DM Recovery Group focuses on assisting individuals with diabetes and an eating disorder - specifically the struggle of withholding insulin.
The group utilizes strategies and tools that have been taught in other EDI programs, and also builds on the strengths of a group.
The group is a means for learning and support as the individuals continue a regular schedule of school, work, and/or family life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adherence to insulin regimen.
Time Frame: Monthly
|
Monthly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Margaret Powers, PhD, RD, CDE, International Diabetes Center at Park Nicollet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Colton P, Olmsted M, Daneman D, Rydall A, Rodin G. Disturbed eating behavior and eating disorders in preteen and early teenage girls with type 1 diabetes: a case-controlled study. Diabetes Care. 2004 Jul;27(7):1654-9. doi: 10.2337/diacare.27.7.1654.
- Goebel-Fabbri AE, Fikkan J, Connell A, Vangsness L, Anderson BJ. Identification and treatment of eating disorders in women with type 1 diabetes mellitus. Treat Endocrinol. 2002;1(3):155-62. doi: 10.2165/00024677-200201030-00003.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
January 5, 2009
First Submitted That Met QC Criteria
January 5, 2009
First Posted (Estimate)
January 7, 2009
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
November 30, 2015
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03653-07-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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