Study of Refeeding to Optimize iNpatient Gains

Study Overview
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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.

Official Title
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Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Other: Higher Calorie Refeeding
* Other: Lower Calorie Refeeding


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Higher Calorie Refeeding Protocol<br>Participants in this arm will receive a higher calorie meal-based refeeding treatment plan in hospital. | Other: Higher Calorie Refeeding<br> <br> |
| Active Comparator: Lower Calorie Refeeding Protocol<br>Participants in this arm will receive a lower calorie meal-based refeeding treatment plan in hospital. | Other: Lower Calorie Refeeding<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Remission at Different Time Points of Assessment | Clinical remission was defined as the combination of percentage mBMI and EDE-Q score at 1, 3, 6, and 12 months. This is a dichotomous variable 1/0. If participants achieve both weight recovery (defined as =>95% of median BMI for sex and age), AND psychological recovery (defined as within 1SD of community norms for EDE-Q) then they are assigned a 1 for achieving clinical remission. If both parameters not met then 0 for not remitted. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Achieve Medical Stability in Hospital | Medical stability was adjudicated by a 6-point clinical index: (1) 24-hour heart rate of 45 beats/min or more, (2) systolic blood pressure of 90 mm Hg or more, (3) temperature of 35.6 °C or more, (4) orthostatic increase in heart rate of 35 beats/min or less, (5) orthostatic decrease in systolic blood pressure of 20 mm Hg or less, and (6) 75% or more of mBMI for age and sex. Criteria were assessed daily; for vital signs with multiple daily measures, the most deviant value was recorded (eg, lowest heart rate). Each criterion was scored as 1 if met, 0 if unmet, and missing (not scored) if not measured. Medical stability was considered restored when all measured criteria were stable for 24 hours, allowing a maximum of 2 missing values. Additional efficacy outcomes were time to restore heart rate to 45 beats/min or more (among those with bradycardia at baseline) and weight gain (change in percentage mBMI). | Inpatient hospitalization from day of admission to day of discharge, average of 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anorexia nervosa, eating disorders, refeeding, adolescent medicine, nutritional rehabilitation