Anorexia NervosaStRONGNCT02488109
Study of Refeeding to Optimize iNpatient Gains
A study testing Higher Calorie Refeeding and Lower Calorie Refeeding in people with Anorexia Nervosa, run by University of California, San Francisco at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Higher Calorie Refeeding and Lower Calorie Refeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to 3 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University Lucille Packard Children's Hospital
Palo Alto, California, 94304
University of California, San Francisco Benioff Children's Hospital
San Francisco, California, 94158
About this study
Official title: Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa
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.
- Conditions
- Anorexia Nervosa
- Being tested
- Higher Calorie Refeeding, Lower Calorie Refeeding
- Keywords
- anorexia nervosa, eating disorders, refeeding, adolescent medicine, nutritional rehabilitation
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher Calorie RefeedingOther
Lower Calorie RefeedingOther
| Study group | Role | What they receive |
|---|---|---|
| Higher Calorie Refeeding Protocol | Active comparator | Participants in this arm will receive a higher calorie meal-based refeeding treatment plan in hospital. Receives: Other: Higher Calorie Refeeding |
| Lower Calorie Refeeding Protocol | Active comparator | Participants in this arm will receive a lower calorie meal-based refeeding treatment plan in hospital. Receives: Other: Lower Calorie Refeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (1)
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).
Measured: Inpatient hospitalization from day of admission to day of discharge, average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completion22 Apr 2020
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Andrea K Garber, PhD, RD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488109
- Sponsor's protocol ID
- P0504491
- Other IDs
- 1R01HD082166-01A1
- Acronym
- StRONG
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2015
- Last updated
- 24 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 41047835Garber AK, Cheng J, Accurso EC, Buckelew SM, Downey AE, Le Grange D, Gorrell S, Kapphahn CJ, Kreiter A, Moscicki AB, Golden NH. Short-term outcomes of the study of refeeding to optimize inpatient gains for patients with atypical anorexia nervosa. Int J Eat Disord. 2024 Apr;57(4):859-868. doi: 10.1002/eat.24115. Epub 2024 Jan 5.
PubMed 38179719Golden 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.
PubMed 33753542Garber 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.
PubMed 33074282Garber 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.
PubMed 31694978
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02488109
- Acronym / sponsor ID
- StRONG / P0504491
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, eating disorders, refeeding, adolescent medicine, nutritional rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Stanford University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Feb 2016 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Posted 24 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher Calorie Refeeding Protocol | Active comparator | Other: Higher Calorie RefeedingParticipants in this arm will receive a higher calorie meal-based refeeding treatment plan in hospital. |
| Lower Calorie Refeeding Protocol | Active comparator | Other: Lower Calorie RefeedingParticipants in this arm will receive a lower calorie meal-based refeeding treatment plan in hospital. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Higher Calorie Refeeding | Other | Higher Calorie Refeeding Protocol |
| Lower Calorie Refeeding | Other | Lower Calorie Refeeding Protocol |
Primary outcome
Number of Participants With Clinical Remission at Different Time Points of Assessment
Time frame: 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.
1 secondary outcome
Time to Achieve Medical Stability in Hospital
Time frame: Inpatient hospitalization from day of admission to day of discharge, average of 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41047835Vendlinski 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.
- Derived from this study: PubMed 38179719Garber AK, Cheng J, Accurso EC, Buckelew SM, Downey AE, Le Grange D, Gorrell S, Kapphahn CJ, Kreiter A, Moscicki AB, Golden NH. Short-term outcomes of the study of refeeding to optimize inpatient gains for patients with atypical anorexia nervosa. Int J Eat Disord. 2024 Apr;57(4):859-868. doi: 10.1002/eat.24115. Epub 2024 Jan 5.
- Derived from this study: PubMed 33753542Golden 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.
- Derived from this study: PubMed 33074282Garber 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.
- Derived from this study: PubMed 31694978Garber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea K Garber, PhD, RD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Higher Calorie Refeeding and Lower Calorie Refeeding in people with Anorexia Nervosa, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Remission at Different Time Points of Assessment (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02488109, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.