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

22 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

90

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • California
      • San Francisco, California, Estados Unidos, 94158
        • University of California, San Francisco Benioff Children's Hospital
        • Contato:
        • Contato:
        • Investigador principal:
          • Andrea K Garber, PhD, RD
    • Colorado
      • Denver, Colorado, Estados Unidos, 80204
        • ACUTE Center for Eating Disorders and Malnutrition at Denver Health
        • Contato:
        • Contato:
        • Subinvestigador:
          • Judy Oakes, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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).

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Refeeding intensity: caloric load to achieve medical stability (predicted by baseline ORMIz)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Baseline ORMIz and severity of malnutrition, medical instability, hypometabolism, and pre-admission energy imbalance
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Post-refeeding (discharge from hospitalization) ORMIz and long-term outcomes (psychopathology, levels of care, rehospitalization)
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of California, San Francisco

Colaboradores

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

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de janeiro de 2027

Conclusão Primária (Estimado)

1 de maio de 2031

Conclusão do estudo (Estimado)

1 de maio de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

25 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de julho de 2026

Primeira postagem (Real)

24 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 1R01HD119553-01A1 (Concessão/Contrato do NIH dos EUA)
  • 26-46188 (Outro identificador: UCSF IRB approval number)
  • R01HD119553 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

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.

Critérios de acesso de compartilhamento IPD

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

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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