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Individualized vs High-Calorie Refeeding for Anorexia Nervosa (i-STRONG Trial)
N/A
Waitlist Available
Led By Andrea K Garber, RD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hospitalized with medical instability, as defined by: night time heart rate (HR) <45 bpm, systolic blood pressure (SBP) <90 mmHg, temperature <35.6° C, orthostatic Δ HR >35 bpm, or orthostatic Δ SBP >20 mmHg
Age 12-24 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-study hospitalization
Awards & highlights
i-STRONG Trial Summary
This trial is comparing two ways of feeding patients with AAN to see which is more effective and has fewer side effects.
Who is the study for?
This trial is for hospitalized youths aged 12-24 with atypical anorexia nervosa, who meet specific health criteria like low heart rate or blood pressure. It's not for those with bulimia, recent refeeding hospital stays, chronic diseases, pregnancy, or acute mental health crises.Check my eligibility
What is being tested?
The study compares Individualized Caloric Refeeding (ICR) to Higher Calorie Refeeding (HCR), focusing on safety and how well they work in treating patients with atypical anorexia nervosa over a year of follow-up.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort, metabolic changes, and psychological distress due to the change in diet and caloric intake during the refeeding process.
i-STRONG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am hospitalized with unstable health due to very low heart rate, blood pressure, or body temperature.
Select...
I am between 12 and 24 years old.
i-STRONG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-study hospitalization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-study hospitalization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Achieve Medical Stability in Hospital
Secondary outcome measures
Incidence of low serum electrolytes during refeeding in hospital
Other outcome measures
Eating Disorder Examination Questionnaire (EDE-Q) Score Over 12 Months
Percentage median BMI (mBMI) Over 12 Months
i-STRONG Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Individualized Caloric Refeeding (ICR)Experimental Treatment1 Intervention
Starting 50 kcal/kg/d, increasing by 200 kcal/d to goal
Group II: Higher Calorie Refeeding (HCR)Active Control1 Intervention
Starting 2000 kcal/d, increasing by 200 kcal/d to goal
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,517 Previous Clinical Trials
15,240,955 Total Patients Enrolled
5 Trials studying Anorexia Nervosa
478 Patients Enrolled for Anorexia Nervosa
Stanford UniversityOTHER
2,406 Previous Clinical Trials
17,343,071 Total Patients Enrolled
14 Trials studying Anorexia Nervosa
1,281 Patients Enrolled for Anorexia Nervosa
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,977 Previous Clinical Trials
2,680,723 Total Patients Enrolled
4 Trials studying Anorexia Nervosa
367 Patients Enrolled for Anorexia Nervosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently experiencing thoughts of harming myself or others, nor am I experiencing a break from reality.I have not been hospitalized for refeeding in the last 6 months.I have a long-term illness affecting my immune system or kidneys.I am hospitalized with unstable health due to very low heart rate, blood pressure, or body temperature.I am between 12 and 24 years old.I am between 12 and 24 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Individualized Caloric Refeeding (ICR)
- Group 2: Higher Calorie Refeeding (HCR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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