RECRUITING

Metabolic Diet for Relapse Prevention in Anorexia Nervosa

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an interventional study that will test the safety, tolerability, and efficacy of the Metabolic Diet, which was designed as a treatment for women with anorexia nervosa to remain weight-stable after they have been restored from low weight. Participants will be adult women with anorexia nervosa who have been recently restored to normal weight and adult women with no history of eating disorders. After enrollment, participants will start meeting weekly with a registered dietitian to implement the Metabolic Diet in their daily lives, and will receive medical monitoring for adherence, side effects, changes in metabolic or psychological parameters, and weight stability.

Official Title

Metabolic Diet for Relapse Prevention in Anorexia Nervosa

Quick Facts

Study Start:2022-11-20
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05197309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Age at least 18 and not over 40
  3. * BMI at or above 18.5 kg/m2
  4. * Speaks English
  5. * Medically stable, as cleared by a licensed physician, with vital signs and initial blood draws
  6. * History of DSM-5 diagnosis of Anorexia Nervosa (WR-AN only)
  7. * Weight-restored from underweight BMI (under 18.5 kg/m2) within the past 6 months (WR-AN only)
  1. * Current/lifetime diagnosis of DSM-5 psychotic disorders, bipolar disorders
  2. * Active DSM-5 substance use disorders
  3. * On medications that could affect metabolism
  4. * History of suicide attempt within previous 6 months or acute suicide risk
  5. * Significant current medical illness or metabolic conditions, including diabetes mellitus and pregnancy
  6. * Current/lifetime diagnosis of DSM-5 eating disorders (HC only)
  7. * Active DSM-5 depressive disorders (HC only)

Contacts and Locations

Study Contact

Chinara Tate
CONTACT
(212) 659-8724
chinara.tate@mssm.edu
Tom Hildebrandt
CONTACT
212-659-8673
tom.hildebrandt@mssm.edu

Principal Investigator

Chinara Tate
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Chinara Tate, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-20
Study Completion Date2024-12

Study Record Updates

Study Start Date2022-11-20
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • anorexia nervosa
  • metabolic diet
  • weight-restored
  • eating disorders

Additional Relevant MeSH Terms

  • Anorexia Nervosa