Study of Refeeding to Optimize iNpatient Gains

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-06-03

Brief Summary

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The purpose of this study is to compare the efficacy, safety, and cost-effectiveness of lower calorie refeeding versus higher calorie refeeding in hospitalized adolescents with anorexia nervosa.

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Detailed Description

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Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Higher Calorie Refeeding Protocol

Participants in this arm will receive a higher calorie meal-based refeeding treatment plan in hospital.

Group Type ACTIVE_COMPARATOR

Higher Calorie Refeeding

Intervention Type OTHER

Lower Calorie Refeeding Protocol

Participants in this arm will receive a lower calorie meal-based refeeding treatment plan in hospital.

Group Type ACTIVE_COMPARATOR

Lower Calorie Refeeding

Intervention Type OTHER

Interventions

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Higher Calorie Refeeding

Intervention Type OTHER

Lower Calorie Refeeding

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis of AN
* atypical AN
* no hospital admissions for the previous six months
* meet hospitalization criteria: daytime heart rate (HR) \< 50 bpm or night time HR \< 45 bpm, blood pressure (BP) \<90/45 mmHg, temperature \< 35.6° C, or symptomatic orthostasis defined by increase in HR \> 35 bpm or decrease in systolic BP \> 20 mmHg or decrease in diastolic BP \> 10 mmHg from lying to standing

Exclusion Criteria

* diagnosis of bulimia nervosa \[DSM-5\]
* currently in remission (as defined by weight and EDE-Q score)
* admission for food refusal without malnutrition
* current pregnancy
* chronic disease (e.g. immune/endocrine disorders, pulmonary, cardiac, or renal disease)
* current suicidality or psychosis
* \< 60% mBMI

Minimum Eligible Age

12 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No