Food Energy Density in Eating Disorders
Relationship of Energy Density of Foods Within a Nutritional Insufficiency Patient's Diet to Inpatient Hospital Stay Duration, Body Image, Mood and Gastrointestinal Symptoms
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.
- To determine whether a higher amount of fat calories per day within a normal range in a Nutritional Insufficiency patient's diet will lead to a shorter inpatient hospital stay duration.
- To determine whether a higher amount of fat calories per day within a normal range in a Nutritional Insufficiency patient's diet will lead to less gastrointestinal re-feeding syndrome symptoms.
- To determine whether a higher amount of fat calories per day within a normal range in a Nutritional Insufficiency patient's diet will effect their body image and/or alter their mood.
調査の概要
状態
詳細な説明
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:
- Control: Intake 35-50 grams of fat per day between meals and snacks - this is the typical amount used within our current inpatient re-feeding meal plan, still within a healthy range as it is at the lower end of normal, which given that these patients typically consume a "low fat" diet prior to admission that this amount has been the standard of care for treatment thus far, if they require any supplemental feedings for incomplete meals it will be with the standard lower fat content supplements
- Treatment: Intake > 50 grams of fat per day between meals and snacks - still within a healthy range as it is at the higher end of normal, if they require any supplemental feedings for incomplete meals it will be with a higher fat content supplement as dictated by the nutrition therapists
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
研究の種類
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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:
- Elevated liver function tests,
- Elevated pancreatic enzymes,
- Expected admission < 24 hours duration,
- Admission on weekends.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
他の:Control Arm = Decreased Energy Density
Decreased energy density = 35-50 grams of fat per day between meals and snacks
|
low fat intake : Intake 35-50 grams of fat per day between meals and snacks
|
他の:Treatment Arm = Increased Energy Density
increased increased energy density : Intake > 50 grams of fat per day between meals and snacks
|
increased fat intake : Intake > 50 grams of fat per day between meals and snacks
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Heart Rate
時間枠:1 year
|
1 year
|
Blood pressure
時間枠:1 year
|
1 year
|
Weight Changes
時間枠:1 year
|
1 year
|
Need for constipation medications
時間枠:1 year
|
1 year
|
Need for supplemental nutrition
時間枠:1 year
|
1 year
|
Need for reflux medications
時間枠:1 year
|
1 year
|
Bloating Symptoms
時間枠:1 year
|
1 year
|
Constipation symptoms
時間枠:1 year
|
1 year
|
Gastroesophageal reflux symptoms
時間枠:1 year
|
1 year
|
Perceived body image
時間枠:1 year
|
1 year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Ellen Rome, MD、The Cleveland Clinic
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
- Determining whether adjustments in the amounts of fat grams within the current inpatient protocol meal plans will lead to a change in the hospital stay duration
- Alter their recovery by affecting vital signs
- Rate of weight change or need for supplemental feeds/medications
- Effect gastrointestinal symptoms (bloating, gastroesophageal reflux, constipation, diarrhea, abdominal pain
- And/or effect their perceived body image or cause any changes in their mood.
その他の研究ID番号
- CCCH-KW
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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