| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD082166-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Higher Calorie Refeeding Protocol | Active Comparator | Participants in this arm will receive a higher calorie meal-based refeeding treatment plan in hospital. |
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| Lower Calorie Refeeding Protocol | Active Comparator | Participants in this arm will receive a lower calorie meal-based refeeding treatment plan in hospital. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Higher Calorie Refeeding | Other |
| ||
| Lower Calorie Refeeding |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness Per Adolescent Recovered | defined as total cost (direct and indirect costs) | up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea K Garber, PhD, RD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Lucille Packard Children's Hospital | Palo Alto | California | 94304 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41047835 | Derived | 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. | |
| 33753542 | Derived |
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Although 120 participants were randomized,116 started on the study. Of the 4 individuals who were randomized but did not receive treatment, 3 were found ineligible and 1 did not complete the consent, leaving 56 individuals in the LCR arm. Of those 56 individuals, an additional 5 individuals withdrew prior to receiving treatment, ultimately resulting in 51 participants in the LCR arm.
Patients were enrolled from February 8, 2016, to March 7, 2019 at 2 clinical sites, large tertiary care children's hospitals with eating disorder inpatient programs attended by interdisciplinary adolescent medicine care teams at the University of California San Francisco and Stanford University. Written informed consent was obtained from young adults and parents of minors, who provided written assent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Higher Calorie Refeeding (HCR) Protocol | Meal-based refeeding in hospital: starting 2000 kcal/d and increasing 200 kcal/d to goal |
| FG001 | Lower Calorie Refeeding (LCR) Protocol | Meal-based refeeding in hospital: starting 1400 kcal/d and increasing 200 kcal every other day to goal |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment in Hospital |
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| ||||||||||||||||||||||||
| 12-month Follow-Up |
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Modified Intention to Treat Analysis (mITT) includes all participants who received treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Higher Calorie Refeeding (HCR) Protocol | Meal-based refeeding in hospital: starting 2000 kcal/d and increasing 200 kcal/d to goal |
| BG001 | Lower Calorie Refeeding (LCR) Protocol |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Clinical remission defined as the combination of %mBMI and EDE-Q score. Instead of assuming missing data at random in the generalized linear mixed-effects regression model, clinical remission was modeled as a nominal multinomial outcome (yes, no, or missing), with time (1, 3, 6, or 12 months after discharge), treatment group, and time*treatment group interaction as fixed effects. Longitudinal analysis included only participants with both %mBMI and EDE-Q scores. | Posted | Count of Participants | Participants | up to 12 months |
|
Participants were monitored for adverse events on an ongoing basis during the treatment period, which was during hospitalization from day of admission to day of discharge (an average of 10 days). After the treatment effect window was completed on discharge from the hospital, adverse events were not considered to be related to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Higher Calorie Refeeding (HCR) | Meal-based refeeding in hospital: starting 2000 kcal/d and increasing 200 kcal/d to goal |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | <2.5 mg/dL |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia (mild) | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | 3.1 - 3.4 mmol/L |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Garber, PhD, RD | University of California, San Francisco, Department of Pediatrics | 415-514-2180 | andrea.garber@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2019 | Mar 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Other |
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| Inpatient hospitalization from day of admission to day of discharge, average of 10 days |
| University of California, San Francisco Benioff Children's Hospital |
| San Francisco |
| California |
| 94158 |
| United States |
| 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. |
| 33074282 | Derived | 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. |
| 31694978 | Derived | 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. |
| COMPLETED | Retained in trial through 12 months |
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| NOT COMPLETED |
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Meal-based refeeding in hospital: starting 1400 kcal/d and increasing 200 kcal every other day to goal
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Admission percentage of median body mass index (%mBMI) | Mean | Standard Deviation | % of mBMI |
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| Lowest 24-hr heart rate, beats/min | Mean | Standard Deviation | beats per minute |
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| Lowest Systolic Blood Pressure (mm Hg) | Mean | Standard Deviation | mm Hg |
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| Global Eating Disorder Examination Questionnaire score (mean, SD) | Scores range from 1-6, with higher scores indicating greater severity. For reference, the EDE-Q global score in community studies is 3.38. | Mean | Standard Deviation | Score on a scale |
|
| Atypical anorexia nervosa (No., %) | Count of Participants | Participants |
|
| OG000 |
| Higher Calorie Refeeding (HCR) Protocol |
Meal-based refeeding in hospital: starting 2000 kcal/d and increasing 200 kcal/d to goal |
| OG001 | Lower Calorie Refeeding (LCR) Protocol | Meal-based refeeding in hospital: starting 1400 kcal/d and increasing 200 kcal every other day to goal |
|
|
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| 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). | Modified intention to treat analysis (mITT) included all participants who received at least one day of treatment | Posted | Mean | Standard Deviation | Days | Inpatient hospitalization from day of admission to day of discharge, average of 10 days |
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| Other Pre-specified | Cost-effectiveness Per Adolescent Recovered | defined as total cost (direct and indirect costs) | The analysis was a modified intent-to-treat (mITT) approach including all randomized participants who received treatment for at least one day. A total of 9 participants were excluded: 3 were found to be ineligible after randomization and 6 withdrew prior to receiving treatment. | Posted | Median | Standard Deviation | USD | up to 12 months |
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|
|
| 0 |
| 60 |
| 14 |
| 60 |
| 14 |
| 60 |
| EG001 | Lower Calorie Refeeding (LCR) | Meal-based refeeding in hospital: starting 1400 kcal/d and increasing 200 kcal every other day to goal. Of the 56 participants originally randomized to this treatment, 5 never received treatment and were therefore excluded from mITT analyses. | 0 | 51 | 10 | 51 | 21 | 51 |
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| Orthostatic increase in heart rate | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | An increase in heart rate from lying (for 5 min) to standing (for 2 min) was categorized as severe in this patient population if it reached a threshold of a change of >75 bpm |
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| Psychiatric SAE, e.g. suicide attempt | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment | All of these psychiatric events occurred during the follow-up period, after patients were no longer in our care |
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| Severe Bradycardia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | <30 bpm |
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| Severe Hypotension | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | <80/40 |
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| Other unrelated SAEs during follow-up period | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | e.g. elevated liver enzymes, sialolithiasis, gallstone pancreatitis, renal calculi, tonic clonic seizure |
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| Hypomagnesemia (mild) | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | 1.3 - 1.7 mg/dL |
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| Hypophosphatemia (moderate) | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | Moderate: 2.5 - 2.9 mg/dL |
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| Superiority |