Food Energy Density in Eating Disorders
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ClinicalTrials.gov Identifier: NCT01095107 |
Recruitment Status :
Withdrawn
(Couldn't offer patients a high/low fat meal plan because food service changes)
First Posted : March 29, 2010
Last Update Posted : March 1, 2019
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Tracking Information | ||||
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First Submitted Date ICMJE | March 19, 2010 | |||
First Posted Date ICMJE | March 29, 2010 | |||
Last Update Posted Date | March 1, 2019 | |||
Actual Study Start Date ICMJE | January 2010 | |||
Actual Primary Completion Date | February 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Food Energy Density in Eating Disorders | |||
Official Title ICMJE | Relationship of Energy Density of Foods Within a Nutritional Insufficiency Patient's Diet to Inpatient Hospital Stay Duration, Body Image, Mood and Gastrointestinal Symptoms | |||
Brief Summary | Nutritional insufficiency is defined as an inadequate amount of nutrition due to decreased food/caloric intake, often due to an eating disorder, such as anorexia nervosa or bulimia. Often when re-feeding these chronically malnourished patients, they can experience changes in their mood and/or body image, metabolic abnormalities and functional aberrations of their gastrointestinal system described as re-feeding syndrome, which all can adversely effect their recovery. In our pilot study, we are attempting to determine whether adjustments in the amounts of energy dense foods, such as fat, in the current inpatient protocol meal plans will lead to a change in the hospital stay duration, alter their recovery by affecting vital signs, weight or need for supplemental feeds or medications, effect gastrointestinal re-feeding syndrome symptoms (bloating, gastroesophageal reflux, constipation, diarrhea, abdominal pain), and/or effect their perceived body image or cause any changes in their mood.
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Detailed Description | A randomized, double blind pilot study; physicians and patients will be blinded as to which treatment group they will be placed, nutrition therapists will perform randomization and placement into each treatment group for this research study, along with the development of daily meal plan as they typically do when not involved in this study, and therefore they will not be blinded. Research Procedures Patients will be placed into one of two groups:
Study instruments - questionnaires distributed and collected on the initial day of admission, on every third day of inpatient stay and on the day of discharge by the nutrition therapists. Due to the lack of research on this method of treatment, there are no questionnaires which have been tested for validity and reliability; therefore we have created our own, which we plan to assess during this pilot study. We also plan to follow-up with the patient and parent(s) at 1 month post-discharge (+/- 1 day) to assess how their re-feeding treatment has been going, along with to assess how they feel and ask about any symptoms they are experiencing. Tests and procedures - all patients with Nutritional Insufficiency/Eating Disorders admitted to the Cleveland Clinic Children's Hospital follow the Nutritional Insufficiency Protocol, with all screening tests and inpatient evaluation and follow-up occurring regardless of whether they are involved in the current pilot study. As per protocol, these patients will be on strict bed rest with a 24 hour companion supervising the patient at all times, especially monitoring intake and timing of completion of all meals, snacks and/or supplements. It is also standard per protocol that they receive Neutra-phos which is a potassium phosphate and sodium phosphate supplement, twice daily for the initial 5 days of treatment. The screening, daily inpatient evaluation, and study questionnaire distribution will be completed on admission, every 3 days, and at discharge |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Supportive Care |
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Condition ICMJE | Nutritional Insufficiency | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE |
0 | |||
Original Estimated Enrollment ICMJE |
20 | |||
Actual Study Completion Date ICMJE | February 2018 | |||
Actual Primary Completion Date | February 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: • Males and females < 25 years of age admitted through the Adolescent Medicine service for inpatient treatment of Nutritional Insufficiency/Eating Disorder or any significant medical abnormalities associated with Nutritional Insufficiency/Eating Disorder. Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 9 Years to 24 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01095107 | |||
Other Study ID Numbers ICMJE | CCCH-KW | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Ellen Rome, The Cleveland Clinic | |||
Study Sponsor ICMJE | The Cleveland Clinic | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | The Cleveland Clinic | |||
Verification Date | February 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |