Eating DisorderNCT00818142
Support Group Surveys for Individuals Who Have Type 1 Diabetes and an Eating Disorder
An observational study of Eating Disorder and Type 1 Diabetes, run by HealthPartners Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorder, Type 1 Diabetes
- What is being tested?
- ED/DM Support Group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Nicollet Eating Disorder Institute
Minneapolis, Minnesota, 55416
About this study
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.
- Conditions
- Eating Disorder, Type 1 Diabetes
- Being tested
- ED/DM Support Group
- Medical subject headings
- Feeding and Eating Disorders, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED/DM Support GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| eating disorder, type 1 diabetes | Individuals diagnosed with type 1 diabetes and an eating disorder who withhold their insulin. Receives: Behavioral: ED/DM Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to insulin regimen.
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, Park Nicollet Eating Disorder Institute, Park Nicollet Foundation
- Responsible party
- Sponsor
- Investigators
- Margaret Powers, PhD, RD, CDE, Principal investigator, International Diabetes Center at Park Nicollet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818142
- Sponsor's protocol ID
- 03653-07-A
- Status last verified
- Aug 2013
- First submitted
- 5 Jan 2009
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15220242Goebel-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.
PubMed 15799208
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Group Surveys for Individuals Who Have Type 1 Diabetes and an Eating Disorder
- ClinicalTrials.gov ID
- NCT00818142
- Acronym / sponsor ID
- 03653-07-A
- Conditions
- Eating Disorder, Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, Park Nicollet Eating Disorder Institute, Park Nicollet Foundation
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eating disorder, type 1 diabetes | – | Behavioral: ED/DM Support GroupIndividuals diagnosed with type 1 diabetes and an eating disorder who withhold their insulin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Have an eating disorder
- Have type 1 diabetes
- Withhold their insulin
- 18 years or older
- Actively being treated at EDI
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ED/DM Support GroupThe 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. | Behavioural | eating disorder, type 1 diabetes |
Primary outcome
Adherence to insulin regimen.
Time frame: Monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 15220242Colton 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.
- Background: PubMed 15799208Goebel-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Powers, PhD, RD, CDE principal investigator
International Diabetes Center at Park Nicollet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorder and Type 1 Diabetes, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to insulin regimen. (time frame: Monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00818142, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.