Study of Refeeding to Optimize iNpatient Gains

University of California, San Francisco120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Anorexia Nervosa

Interventions

Higher Calorie RefeedingOTHER

Lower Calorie RefeedingOTHER

Eligibility

Sex: ALLMin age: 12 YearsMax age: 24 Years

Medical Language ↔ Plain English

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

Locations (2)

Stanford University Lucille Packard Children's Hospital

Palo Alto, California, United States

University of California, San Francisco Benioff Children's Hospital

San Francisco, California, United States

Outcomes

Primary Outcomes

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.

Time frame: up to 12 months

Secondary Outcomes

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).

Time frame: Inpatient hospitalization from day of admission to day of discharge, average of 10 days

Data from ClinicalTrials.gov

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