Study of Refeeding to Optimize iNpatient Gains

Anorexia Nervosa Clinical Trial

— StRONG  

Official title:

Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488109
• Other study ID #: P0504491
• Secondary ID: 1R01HD082166-01A
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 3, 2020

Study information

• Verified date: June 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT02621229

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 3, 2020
• Est. primary completion date: April 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• Higher Calorie Refeeding

• Lower Calorie Refeeding

Locations

Country	Name	City	State
United States	Stanford University Lucille Packard Children's Hospital	Palo Alto	California
United States	University of California, San Francisco Benioff Children's Hospital	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness Per Adolescent Recovered	defined as total cost (direct and indirect costs)	up to 12 months
Primary	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	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