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

NCT07726524 | Not Yet Recruiting

• 3 other identifiers: 1R01HD119553-01A126-46188R01HD119553
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anorexia in Adolescence; Anorexia Nervosa; Anorexia Nervosa, Atypical; Anorexia Nervosa, Binge Eating/Purging Type; Anorexia Nervosa Restricting Type; Anorexia Nervosa With Significantly Low Body Weight; Body Composition Changes; Growth & Development; Malnutrition Severe; Malnutrition, Calorie

Keywords

Organ residual mass; Body composition; Three-dimensional optical imaging; Optical body scanning; Refeeding; Refeeding syndrome; Nutritional rehabilitation; Resting energy expenditure; Eating disorders; Bioelectrical impedance analysis; Fat-free mass; Adolescent; Young adult; Anorexia nervosa; Growth charts

Outcome Measures

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.

  From hospital admission to medical stability, up to 4 weeks

Secondary Outcomes (2)

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

  Baseline (hospital admission)

• Change in body composition during refeeding and medical/metabolic recovery

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

Other Outcomes (2)

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

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

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

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

Eligibility Criteria

• Age: 15 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• Diagnosis of anorexia nervosa (AN) or atypical anorexia nervosa (AAN), restricting or purging subtype, per DSM-5
• Age 15 to 26 years
• Medical instability warranting an inpatient hospitalization defined by either:
• 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
• Extreme AN is defined as BMI below 15 kg/m2 or serious medical complications warranting admission to ACUTE (Denver Site).

You may not qualify if:

• Bulimia nervosa
• Another primary diagnosis causing malnutrition (not an eating disorder)
• Current active suicidality
• Metal implants or devices that interfere with study procedures

Sponsors & Collaborators

• University of California, San Francisco: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Denver Health and Hospital Authority: collaborator
• University of Hawaii: collaborator

Study Sites (2)

University of California, San Francisco Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

ACUTE Center for Eating Disorders and Malnutrition at Denver Health

Denver, Colorado, 80204, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will bank serum and stool for additional analysis. DNA may be extracted for analysis.

MeSH Terms

Conditions

Anorexia Nervosa; Bulimia; Malnutrition; Refeeding Syndrome; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Andrea K Garber, PhD, RD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea K Garber, PhD, RD

CONTACT

415-514-2180; andrea.garber@ucsf.edu

Arjun S Mehta, MPH

CONTACT

415-476-8195; arjun.mehta@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available no later than one year after the end of the follow-up period (March 2032) or at the time of associated publications, whichever occurs first, and will remain available through the repository thereafter.
• Access Criteria: Data will be made available via the NIH Data and Specimen Hub (DASH) Repository after the study completion.

Locations

US (2)