Clinical trial NCT02488109: Study of Refeeding to Optimize iNpatient Gains
Official title: Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: anorexia nervosa
eating disorders
refeeding
adolescent medicine
nutritional rehabilitation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-07-02
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Clinical Remission at Different Time Points of Assessment
timeFrame: up to 12 months
Secondary outcomes:
measure: Time to Achieve Medical Stability in Hospital
timeFrame: Inpatient hospitalization from day of admission to day of discharge, average of 10 days
Other outcomes:
measure: Cost-effectiveness Per Adolescent Recovered
timeFrame: up to 12 months
Locations:
city: Palo Alto
country: United States
facility: Stanford University Lucille Packard Children's Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Benioff Children's Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Andrea K Garber, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Golden NH, Cheng J, Kapphahn CJ, Buckelew SM, Machen VI, Kreiter A, Accurso EC, Adams SH, Le Grange D, Moscicki AB, Sy AF, Wilson L, Garber AK. Higher-Calorie Refeeding in Anorexia Nervosa: 1-Year Outcomes From a Randomized Controlled Trial. Pediatrics. 2021 Apr;147(4):e2020037135. doi: 10.1542/peds.2020-037135. Epub 2021 Mar 22.
citation: Garber AK, Cheng J, Accurso EC, Adams SH, Buckelew SM, Kapphahn CJ, Kreiter A, Le Grange D, Machen VI, Moscicki AB, Sy A, Wilson L, Golden NH. Short-term Outcomes of the Study of Refeeding to Optimize Inpatient Gains for Patients With Anorexia Nervosa: A Multicenter Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):19-27. doi: 10.1001/jamapediatrics.2020.3359.
citation: Garber AK, Cheng J, Accurso EC, Adams SH, Buckelew SM, Kapphahn CJ, Kreiter A, Le Grange D, Machen VI, Moscicki AB, Saffran K, Sy AF, Wilson L, Golden NH. Weight Loss and Illness Severity in Adolescents With Atypical Anorexia Nervosa. Pediatrics. 2019 Dec;144(6):e20192339. doi: 10.1542/peds.2019-2339. Epub 2019 Nov 6.