Type 1 DiabetesNCT00948311
Develop and Validate a Self-Administered Instrument That Will Screen for Eating Disorder Symptoms in Persons Aged 12 and Older With Type 1 Diabetes.
An observational study of Type 1 Diabetes and Eating Disorder, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Type 1 Diabetes, Eating Disorder
- How many people
- 279 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2015
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: International Diabetes Center patient with type 1 diabetes and an eating disorder.
Who may be able to join
- eating disorder
- type 1 diabetes
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
International Diabetes Center
Minneapolis, Minnesota, 55416
About this study
Official title: Development of an Instrument to Screen for Eating Disorder Symptoms in Persons With Type 1 Diabetes
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.
Read the 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)?
- Conditions
- Type 1 Diabetes, Eating Disorder
- Medical subject headings
- Diabetes Mellitus, Type 1, Feeding and Eating Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2015
- Study completionDec 2015
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 Type 1 DiabetesStudies 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
- 279 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, Principal investigator, International Diabetes Center at Park Nicollet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948311
- Sponsor's protocol ID
- 03798-08-A
- Status last verified
- Feb 2016
- First submitted
- 27 Jul 2009
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Papers have been published on the study.
Publications
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.
PubMed 27932687Powers 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.
PubMed 26124085
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Instrument to Screen for Eating Disorder Symptoms in Persons With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00948311
- Acronym / sponsor ID
- 03798-08-A
- Conditions
- Type 1 Diabetes, Eating Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 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
- Dec 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Jul 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.
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)?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- International Diabetes Center patient with type 1 diabetes and an eating disorder.
Key inclusion criteria (2 listed)
- eating disorder
- type 1 diabetes
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 19 Feb 2016.
- Derived from this study: PubMed 27932687Powers 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.
- Derived from this study: PubMed 26124085Powers 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.
- Individual participant dataSharing planned: Yes. Papers have been published on the study.
Related trials for Type 1 Diabetes
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
RecruitingObservational study
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Type1diabetes
RecruitingPhase 2
Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
Colon Cancer
Active, not recruitingObservational study
Epidemiology of Diabetes Interventions and Complications (EDIC)
Type 1 Diabetes Mellitus
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
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 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 Type 1 Diabetes and Eating Disorder, 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 2 inclusion and 1 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 19 Feb 2016. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00948311, 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 19 Feb 2016.