Study of Refeeding to Optimize iNpatient Gains
StRONG
Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa
2 other identifiers
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2020
CompletedResults Posted
Study results publicly available
June 24, 2021
CompletedJune 24, 2021
June 1, 2021
4.2 years
June 23, 2015
April 21, 2021
June 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Time to Achieve Medical Stability in Hospital
Inpatient hospitalization from day of admission to day of discharge, average of 10 days
Other Outcomes (1)
Cost-effectiveness Per Adolescent Recovered
up to 12 months
Study Arms (2)
Higher Calorie Refeeding Protocol
ACTIVE COMPARATORParticipants in this arm will receive a higher calorie meal-based refeeding treatment plan in hospital.
Lower Calorie Refeeding Protocol
ACTIVE COMPARATORParticipants in this arm will receive a lower calorie meal-based refeeding treatment plan in hospital.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Stanford University Lucille Packard Children's Hospital
Palo Alto, California, 94304, United States
University of California, San Francisco Benioff Children's Hospital
San Francisco, California, 94158, United States
Related Publications (4)
Vendlinski SS, Gorrell S, Downey AE, Mehta AS, Le Grange D, Machen VI, Accurso EC, Buckelew SM, Kapphahn CJ, Moscicki BA, Golden NH, Garber AK. Self-Reported Physical Activity Energy Expenditure in Patients With Anorexia Nervosa: A Cross-Sectional Analysis at Hospital Admission From the Study of Refeeding to Optimize iNpatient Gains. Int J Eat Disord. 2026 Jan;59(1):122-133. doi: 10.1002/eat.24569. Epub 2025 Oct 6.
PMID: 41047835DERIVEDGolden 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.
PMID: 33753542DERIVEDGarber 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.
PMID: 33074282DERIVEDGarber 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.
PMID: 31694978DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrea Garber, PhD, RD
- Organization
- University of California, San Francisco, Department of Pediatrics
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea K Garber, PhD, RD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2015
First Posted
July 2, 2015
Study Start
February 1, 2016
Primary Completion
April 22, 2020
Study Completion
June 3, 2020
Last Updated
June 24, 2021
Results First Posted
June 24, 2021
Record last verified: 2021-06