Study of Refeeding to Optimize iNpatient Gains (StRONG)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Anorexia Nervosa

Treatments: Other: Lower Calorie Refeeding; Other: Higher Calorie Refeeding

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02488109

P0504491

1R01HD082166-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 12 to 24 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Higher Calorie Refeeding Protocol

Active Comparator group

Description:

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

Treatment:

Other: Higher Calorie Refeeding

Lower Calorie Refeeding Protocol

Active Comparator group

Description:

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

Treatment:

Other: Lower Calorie Refeeding