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3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study

ConditionsAnorexia in AdolescenceAnorexia NervosaAnorexia Nervosa, AtypicalAnorexia Nervosa, Binge Eating/Purging TypeAnorexia Nervosa Restricting TypeAnorexia Nervosa With Significantly Low Body WeightBody Composition ChangesGrowth & DevelopmentMalnutrition SevereMalnutrition, Calorie
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-26
SponsorUniversity of California, San Francisco

About this trial

People with anorexia nervosa often become medically unstable because of severe malnutrition and require hospitalization for nutritional rehabilitation. Clinicians currently rely heavily on body weight to assess malnutrition, but body weight does not always reflect the severity of illness. This study will use infrared scanning to assess body composition in adolescents and young adults hospitalized with anorexia nervosa. Researchers will then examine how organ and tissue stores relate to the degree of malnutrition, predict nutritional needs and medical restoration in hospital, and recovery outcomes over the following year. The goal is to develop more individualized approaches to nutritional rehabilitation and improve recovery for individuals with malnutrition due to eating disorders.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of anorexia nervosa (AN) or atypical anorexia nervosa (AAN), restricting or purging subtype, per DSM-5

Age 15 to 26 years

vital signs: daytime heart rate below 50 bpm or nighttime heart rate below 45 bpm, blood pressure below 90/50 mm Hg, temperature below 36 C, orthostatic increase in heart rate above 20 bpm or decrease in systolic blood pressure above 20 mm Hg or decrease in diastolic blood pressure above 10 mm Hg from lying to standing, or median BMI below 75 percent; or

laboratory abnormality: AST above 40 IU/L, ALT above 30 IU/L, estimated GFR below 90 or cystatin C below 0.7 mg/L, albumin below 3.7 g/dL, or prealbumin below 20 mg/dL

Disqualifiers

Bulimia nervosa

Another primary diagnosis causing malnutrition (not an eating disorder)

Current active suicidality

Metal implants or devices that interfere with study procedures

Trial population

Adolescents and young adults ages 15 to 26 hospitalized with medical instability and malnutrition due to atypical anorexia nervosa, anorexia nervosa, or extreme anorexia nervosa, enrolled at admission at two clinical sites (UCSF Benioff Children's Hospital and the ACUTE Center for Eating Disorders and Malnutrition at Denver Health).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Refeeding intensity: caloric load to achieve medical stability (predicted by baseline ORMIz)

Total caloric load required to restore medical stability during hospitalization, analyzed as a function of baseline organ residual mass index z-score (ORMIz). Primary hypothesis (Aim 1, H3): lower baseline ORMIz predicts greater refeeding intensity, including higher caloric load and more refeeding complications such as edema and electrolyte shifts. This is the endpoint on which the study is powered.

Time frame
From hospital admission to medical stability, up to 4 weeks

Secondary outcomes

1

Baseline ORMIz and severity of malnutrition, medical instability, hypometabolism, and pre-admission energy imbalance

Association of baseline organ residual mass index z-score (ORMIz) with (a) markers of malnutrition (body composition, grip strength, Nutrition Risk Score), medical instability (vital signs, organ function, cardiac mass), and hypometabolism (resting energy expenditure and hormonal markers) (Aim 1, H1); and (b) pre-admission energy imbalance (intake minus expenditure), evaluated independent of BMI (Aim 1, H2).

Time frame
Baseline (hospital admission)
2

Change in body composition during refeeding and medical/metabolic recovery

Change in organ residual mass (ORM), fat-free mass, and fat mass from admission through refeeding, and its association with improvement in medical stability (H1) and hypometabolism (H2), plus the relationship of ORM change to lower baseline fat mass (H3) (Aim 2).

Time frame
From hospital admission to post-refeeding assessment, up to 4 weeks

Other outcomes

1

Post-refeeding (discharge from hospitalization) ORMIz and long-term outcomes (psychopathology, levels of care, rehospitalization)

Post-refeeding from hospitalizations' (hospital duration approximately 1 to 4 weeks) association with ORMIz with long-term outcomes, including eating disorder psychopathology and behaviors (EDE-Q), need for higher levels of care such as residential treatment, and eating-disorder-related rehospitalization (Aim 3).

Time frame
3, 6, 9, and 12 months after hospital discharge
2

Post-refeeding (discharge from hospitalization) ORMIz and long-term outcomes (psychopathology, levels of care, rehospitalization)

Post-refeeding from hospitalizations' (hospital duration approximately 1-4 weeks) association with ORMIz with long-term outcomes, including eating disorder psychopathology and behaviors (EDE-Q), need for higher levels of care such as residential treatment, and eating-disorder-related rehospitalization (Aim 3).

Time frame
3, 6, 9, and 12 months after hospital discharge

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

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

Collaborator

Denver Health and Hospital Authority

Collaborator

University of Hawaii

Collaborator

Source ClinicalTrials.gov

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