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Study of Refeeding to Optimize iNpatient Gains (StRONG)

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Higher Calorie Refeeding
Lower Calorie Refeeding
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring anorexia nervosa, eating disorders, refeeding, adolescent medicine, nutritional rehabilitation

Eligibility Criteria

12 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Lucille Packard Children's Hospital
  • University of California, San Francisco Benioff Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Higher Calorie Refeeding Protocol

Lower Calorie Refeeding Protocol

Arm Description

Participants in this arm will receive a higher calorie meal-based refeeding treatment plan in hospital.

Participants in this arm will receive a lower calorie meal-based refeeding treatment plan in hospital.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
June 23, 2015
Last Updated
June 2, 2021
Sponsor
University of California, San Francisco
Collaborators
Stanford University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02488109
Brief Title
Study of Refeeding to Optimize iNpatient Gains
Acronym
StRONG
Official Title
Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 22, 2020 (Actual)
Study Completion Date
June 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Stanford University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
anorexia nervosa, eating disorders, refeeding, adolescent medicine, nutritional rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Higher Calorie Refeeding Protocol
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive a higher calorie meal-based refeeding treatment plan in hospital.
Arm Title
Lower Calorie Refeeding Protocol
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive a lower calorie meal-based refeeding treatment plan in hospital.
Intervention Type
Other
Intervention Name(s)
Higher Calorie Refeeding
Intervention Type
Other
Intervention Name(s)
Lower Calorie Refeeding
Primary Outcome Measure Information:
Title
Number of Participants With Clinical Remission at Different Time Points of Assessment
Description
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.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Time to Achieve Medical Stability in Hospital
Description
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).
Time Frame
Inpatient hospitalization from day of admission to day of discharge, average of 10 days
Other Pre-specified Outcome Measures:
Title
Cost-effectiveness Per Adolescent Recovered
Description
defined as total cost (direct and indirect costs)
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea K Garber, PhD, RD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Lucille Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California, San Francisco Benioff Children's Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33753542
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.
Results Reference
derived
PubMed Identifier
33074282
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.
Results Reference
derived
PubMed Identifier
31694978
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.
Results Reference
derived

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Study of Refeeding to Optimize iNpatient Gains

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