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Completed

NCT Number: NCT02488109

Study of Refeeding to Optimize iNpatient Gains

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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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

12 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Lucille Packard Children's Hospital, Palo Alto, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Higher Calorie Refeeding

Other

Lower Calorie Refeeding

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to Achieve Medical Stability in Hospital

    Time frame: Inpatient hospitalization from day of admission to day of discharge, average of 10 days

    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).

Other outcomes

  1. Cost-effectiveness Per Adolescent Recovered

    Time frame: up to 12 months

    defined as total cost (direct and indirect costs)

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Stanford University

Registry information

Official study title

Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa

Acronym: StRONG

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2015
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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