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

22. Juli 2026 aktualisiert von: University of California, San Francisco
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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

Background: The proposed project is aligned with NIH's Strategic Plan for Nutrition Research (SPNR) Objectives 4-2 and 4-3, to reduce the burden of malnutrition in clinical settings. Up to 40% of patients with anorexia nervosa (AN) become medically unstable due to malnutrition and require hospitalization for refeeding; 25% progress to severe and enduring illness. Long, intensive hospitalizations with frequent readmissions drive high healthcare costs in AN. Historically, clinicians have relied on body weight to assess malnutrition and response to intervention. However, body weight lost diagnostic power due to rising BMIs. About one third of patients today are diagnosed with atypical AN (AAN), with medical instability at "normal" weight. The upward shift in BMI is reflected globally, leading new recommendations to include body composition to diagnose malnutrition. Emphasis is on low fat free mass (FFM) as a predictor of poor hospital outcomes. However, this has not been examined in hospitalized patients with AN, who are often too medically unstable to transport for research scans. This gap can now be filled with whole-body, infrared, 3-dimensional optical imaging (3DO) at the bedside. Prior work by the investigators showed excellent concordance between 3DO and dual X-ray absorptiometry (DXA) for detecting malnutrition at low BMI and captured changes in FFM with bedside 3DO during refeeding. Proposed project: The investigators will employ a functional approach to body composition, integrating compartment mass with physiologic function, to assess malnutrition and predict short-term and long-term refeeding outcomes across the malnutrition continuum. Prior research on FFM has focused on the skeletal muscle and bone components and long-term risks in AN. In contrast, organ residual mass (ORM), which comprises 43% of FFM, has received little attention despite its central role in refeeding. Profound ORM depletion in AN (loss of 43% cardiac, 22% renal, and 39% hepatic mass) contributes to organ dysfunction, hypometabolism, and refeeding complications. The investigators will generate ORM reference values from large, representative datasets, calculate ORM index z-scores (ORMIz), and examine their correlation with malnutrition at baseline, in response to short-term refeeding intensity, and as a predictor of long-term outcomes in patients across the continuum of malnutrition due to AN. Purpose, hypotheses and design: This multicenter, prospective, observational study will include N=90 hospitalized 15 to 26 year olds with medical instability and malnutrition due to AAN, AN, or extreme AN.

Aim 1) Assess clinical utility of ORMIz at admission. Lower baseline ORMIz will: H1) correlate with malnutrition markers, H2) correlate with pre-admission energy imbalance, and H3-Primary) predict refeeding intensity.

Aim 2) Monitor response to refeeding in hospital. Change in ORM will correlate with: H1) medical stability, H2) metabolic stability, and H3) lower baseline FM.

Aim 3) Predict long-term outcomes. Lower discharge ORMIz will predict poor outcomes at 3, 6, 9, and 12 months. Findings will be rapidly translated into individualized refeeding approaches.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

90

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • California
      • San Francisco, California, Vereinigte Staaten, 94158
        • University of California, San Francisco Benioff Children's Hospital
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Andrea K Garber, PhD, RD
    • Colorado
      • Denver, Colorado, Vereinigte Staaten, 80204
        • ACUTE Center for Eating Disorders and Malnutrition at Denver Health
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Judy Oakes, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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).

Beschreibung

Inclusion Criteria:

  • 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:

    1. 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
    2. 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).

Exclusion Criteria:

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Refeeding intensity: caloric load to achieve medical stability (predicted by baseline ORMIz)
Zeitfenster: From hospital admission to medical stability, up to 4 weeks
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Baseline ORMIz and severity of malnutrition, medical instability, hypometabolism, and pre-admission energy imbalance
Zeitfenster: Baseline (hospital admission)
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).
Baseline (hospital admission)
Change in body composition during refeeding and medical/metabolic recovery
Zeitfenster: From hospital admission to post-refeeding assessment, up to 4 weeks
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).
From hospital admission to post-refeeding assessment, up to 4 weeks

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Post-refeeding (discharge from hospitalization) ORMIz and long-term outcomes (psychopathology, levels of care, rehospitalization)
Zeitfenster: 3, 6, 9, and 12 months after hospital discharge
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).
3, 6, 9, and 12 months after hospital discharge
Post-refeeding (discharge from hospitalization) ORMIz and long-term outcomes (psychopathology, levels of care, rehospitalization)
Zeitfenster: 3, 6, 9, and 12 months after hospital discharge
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).
3, 6, 9, and 12 months after hospital discharge

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, San Francisco

Mitarbeiter

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Denver Health and Hospital Authority
University of Hawaii

Ermittler

  • Hauptermittler: Andrea K Garber, PhD, RD, University of California, San Francisco

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Januar 2027

Primärer Abschluss (Geschätzt)

1. Mai 2031

Studienabschluss (Geschätzt)

1. Mai 2031

Studienanmeldedaten

Zuerst eingereicht

25. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juli 2026

Zuerst gepostet (Tatsächlich)

24. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1R01HD119553-01A1 (US NIH Stipendium/Vertrag)
  • 26-46188 (Andere Kennung: UCSF IRB approval number)
  • R01HD119553 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data underlying the published results will be shared, together with the study protocol, statistical analysis plan, and informed consent form.

IPD-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

Data will be made available via the NIH Data and Specimen Hub (DASH) Repository after the study completion.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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