A Study to Evaluate a Primary Care-Based Intervention for Adolescent Restrictive Eating Disorders

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-006679
    Sponsor Protocol Number: 18-006679

About this study

The purpose of this study is to assess the feasibility, acceptability, usability, and preliminary outcomes of a treatment protocol (FBT-PC) for PCP management of adolescent restrictive eating disorders.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Patient aged 0-21 years old and living at home and able to be seen in a Pediatric practice.
  • Caregiver age range is 0-80 years old.
  • Exhibiting dietary restriction and related weight loss or failure to achieve expected weight gain.
  • Restrictive eating disorder diagnosis (anorexia nervosa, ARFID, OSFED characterized by restriction and weight loss/failure to achieve expected weight gain) OR have clinically significant eating disorder symptoms.
  • Eligible patients must also have at least 1 caregiver with whom they live for the majority of the time willing to enroll in the study.

Exclusion Criteria: 

  • Received eating disorder treatment in the past, or have received the recommendation to pursue eating disorder treatment in the past.  Eating disorder or mental health symptoms necessitate a higher level of care.
  • Reported purging at a frequency of more than twice per month.
  • A 2 on Item 9 on the CDI AND active suicidal plan and/or intent upon further evaluation.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jocelyn Lebow, Ph.D., L.P.

Open for enrollment

Contact information:

Jocelyn Lebow Ph.D., L.P.

127or7782734

Lebow.Jocelyn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20455983

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