Study of Refeeding to Optimize iNpatient Gains
- Conditions
- Anorexia Nervosa
- Interventions
- Other: Lower Calorie RefeedingOther: Higher Calorie Refeeding
- Registration Number
- NCT02488109
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lower Calorie Refeeding Protocol Lower Calorie Refeeding Participants in this arm will receive a lower calorie meal-based refeeding treatment plan in hospital. Higher Calorie Refeeding Protocol Higher Calorie Refeeding Participants in this arm will receive a higher calorie meal-based refeeding treatment plan in hospital.
- Primary Outcome Measures
Name Time Method Number of Participants With Clinical Remission at Different Time Points of Assessment up to 12 months 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.
- Secondary Outcome Measures
Name Time Method Time to Achieve Medical Stability in Hospital Inpatient hospitalization from day of admission to day of discharge, average of 10 days 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).
Trial Locations
- Locations (2)
University of California, San Francisco Benioff Children's Hospital
🇺🇸San Francisco, California, United States
Stanford University Lucille Packard Children's Hospital
🇺🇸Palo Alto, California, United States