Eating DisordersNCT05814653
A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders
A study testing Family Based Treatment-Primary Care and Family-Based Treatment in people with Eating Disorders, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility of a RCT of a new treatment for children and adolescents with eating disorders characterized by dietary restriction and/or weight loss or failure to gain expected weight. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Family Based Treatment-Primary Care and Family-Based Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of a DSM-5 restrictive eating disorder (anorexia nervosa or other specified feeding or eating disorder characterized by dietary restriction and/or weight loss or failure to make expected weight gains).
- Eligible patients will have at least one caregiver who is also willing to participate in the study.
- Eligible patients must receive primary care through the MCHS
Who cannot join
- Patients will be excluded who have received FBT in the past, and/or who report active suicidality.
- Patients who become physically or psychiatrically unstable during the study will be re-evaluated and referred for appropriate treatment.
- Patients will be excluded if their enrolled caregiver has active substance dependence, mental health concerns that make it difficult to engage in treatment, or are perpetrators of abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Evaluating the Feasibility of a Primary Care-based Treatment for Restrictive Eating Disorders in Children and Adolescents in the Health System
The purpose of this study is to test the feasibility of a RCT of a new treatment for children and adolescents with eating disorders characterized by dietary restriction and/or weight loss or failure to gain expected weight. The treatment, which is called Family-Based Treatment for Primary Care (or FBT-PC for short), is based on Family-Based Treatment, the gold standard outpatient eating disorder treatment for children and adolescents.
Read the detailed description
In the United States, half a million adolescents suffer from an eating disorder. With only 66 certified providers nationally, Family-Based Treatment (FBT), a first-line evidence-based treatment for adolescent eating disorders, is not readily available to most families. This provider shortage leaves most young patients without care and undoubtedly contributes to the chronicity and lethality of these conditions. Patients with eating disorders generally make their first contact with the healthcare system in primary care. As such, equipping primary care providers (PCPs) with effective means to treat these patients has potential to democratize care, improve rates of early intervention, and enhance patient outcomes. Family-Based Treatment for Primary Care (FBT-PC) is a novel intervention for delivery by a PCP in primary care that uses FBT strategies. Data support proof-of-concept for this adaptation. This study has several study aims. (1) Finalize the FB-PC intervention through an open case series. (2) Establish the feasibility and acceptability of FBT-PC for caregivers, patients, and PCPs in a pilot randomized controlled trial. Finally, (3) to test preliminary target engagement of FBT-PC and determine whether it is associated with improved caregiver self-efficacy and, through this mechanism, symptom remission. Remission will be defined as weight restoration to 95% of expected body weight and a score within 1 SD of community norms on the Eating Disorder Examination-Questionnaire. In addition, as (4) an exploratory aim analyses will be conducted to evaluate baseline characteristics of the sample to determine for whom the FBT-PC intervention is most beneficial. To accomplish all aims an open case series (n = 6) will be conducted, followed by a pilot trial in which 40 patients (ages 7-18 years) with restrictive eating disorders and their caregiver(s) will be randomly assigned to FBT-PC or a control condition of standard FBT. Families will attend up to 18 sessions over 6 months. Goals from the open case series (Aim 1) will include the development of tools for FBT-PC training and implementation, including treatment and training protocols and fidelity measures. Feasibility (Aim 2) will be assessed through an evaluation of recruitment and retention. Acceptability (Aim 2) will be evaluated using mixed methods surveys and interviews of caregivers, patients and PCPs on the topics of tolerability, fit, and burden. The degree to which FBT-PC engages the proposed mechanism of change, caregiver self-efficacy, to facilitate symptom remission will also be assessed (Aim 3). Effect sizes will be calculated for FBT-PC with a goal of ≥ 0.5, comparable with those found in FBT trials. Finally, baseline sample characteristics (Exploratory Aim) will be assessed including caregiver perceptions about their child's illness, referral method, length of illness, and symptom severity. Once feasibility, acceptability, and target engagement of the FBT-PC intervention have been established, these findings will be used in support of a large pragmatic clinical trial to evaluate the noninferiority of effectiveness of FBT-PC versus standard FBT.
- Conditions
- Eating Disorders
- Being tested
- Family Based Treatment-Primary Care, Family-Based Treatment
- Keywords
- Children and Adolescents
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Based Treatment-Primary CareBehavioural
Also called FBT-PC
Novel treatment that borrows key intervention strategies from standard family-based treatment. It uses trained primary care providers (PCPs), in consultation with a mental health provider, to deliver family-based treatment strategies in community-based clinics to increase caregiver self-efficacy to reverse their child's dietary restriction and weight loss.
Family-Based TreatmentBehavioural
Also called FBT
Delivered by a mental health provider in a traditional mental health or eating disorder specialty setting. First-line evidence-based treatment for adolescent eating disorders that targets caregiver self-efficacy as a mechanism to facilitate weight restoration and ultimately symptom remission in adolescents.
| Study group | Role | What they receive |
|---|---|---|
| FBT-PC delivered by a primary care provider | Experimental | Subjects will receive up to 18 sessions of FBT-PC, delivered by a primary care provider, at their primary care clinic over 6 months. Receives: Behavioral: Family Based Treatment-Primary Care |
| Standard FBT | Active comparator | Subjects will receive up to 18 session of FBT, delivered by a specialist mental health provider at Mayo Clinic in Rochester, MN over 6 months. Receives: Behavioral: Family-Based Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment across 3 years
Recruitment rate will be tracked, with a goal of enrollment of 75% of eligible participants.
Measured: Rate of recruitment at end of study (3 years)
Rate of retention across 3 years
Retention rate will be tracked, with a target retention rate (attendance at >80% of sessions) of 70%.
Measured: Rate of retention at end of study (3 years)
Mixed methods feedback survey at end of treatment (caregiver/patient)
This is a unique survey with quantitative (Likert scale rating/ yes/no questions) and qualitative (short answer) questions that assesses treatment satisfaction, acceptability of session frequency, length, and therapeutic alliance, as well as comfort and familiarity with treatment intervention components. Higher scores on Likert scales indicate greater satisfaction/acceptability.
Measured: Assessed after the final session (within 6 months)
Rate of retention across 3 years
Rate of retention (defined as attendance at > 80% of sessions) will be tracked, with a target of <30% attrition.
Measured: Rate of retention at end of study (3 years)
Secondary outcomes (10)
Parents versus Anorexia Scale (caregiver)
The degree to which FBT-PC engages the proposed mechanism of change, caregiver self-efficacy, will be assessed through this well-validated caregiver-report measure. This is a 7-item of caregiver self-efficacy that has been widely used in the eating disorder treatment literature. Items assess parental efficacy in the Maudsley model of family-based treatment for anorexia nervosa. Scores range from 5-35, with higher scores indicated higher self efficacy
Measured: Monthly across the intervention (up to 6 months)
Parent Sense of Competency Scale (caregiver)
The degree to which FBT-PC engages the proposed mechanism of change, caregiver self-efficacy, will be assessed through this well-validated caregiver-report measure, a 17-item measure of general parenting competency beliefs. Items are rated on a 1-6 Likert scale, with scores ranging from 17-102, with higher scores indicating higher parenting competency beliefs.
Measured: Monthly across the intervention (up to 6 months)
Eating Disorder Symptom Reduction (patient)
Patient weight restoration and reduction in behavioral/cognitive eating disorder symptoms as measured by the Eating Disorder Examination-Questionnaire or child Eating Disorder Examination-Questionnaire for patients ages 7-12. Higher scores on the 4 subscales and Global scale of these measures range from 0-6, with higher scores indicating more severe eating disorder symptomology.
Measured: Pre/post intervention (up to 6 months)
Internalized Stigma of Mental Illness Scale (caregiver/patient)
The internalized stigma of having an eating disorder will be measured by the Internalized Stigma of Mental Illness Scale, a 20-item measure. This measure has been validated in populations of patients with eating disorders and will be modified to also be relevant for caregivers. Items are rated 1-4, with possible scores ranging from 29-116. Higher scores indicate higher internalized stigma.
Measured: Pre/post intervention (up to 6 months)
Treatment experience feedback survey- Year 1 (provider)
Mixed methods surveys will be collected from primary care providers providing FBT-PC and within the participating practices, to assess their perceptions of their experience providing and referring to the intervention. HIgher scores on quantitative items (Likert scales rated 1-5) will indicated greater satisfaction.
Measured: End of Year 1 of the study
Treatment experience feedback survey- Year 2 (provider)
Mixed methods surveys will be collected from primary care providers providing FBT-PC and within the participating practices, to assess their perceptions of their experience providing and referring to the intervention. HIgher scores on quantitative items (Likert scales rated 1-5) will indicated greater satisfaction.
Measured: End of Year 2 of the study
Qualitative treatment experience feedback interview- Year 1 (provider)
30-60 minute semi-structured interviews will be conducted with primary care providers providing FBT-PC and within the participating practices, to assess their experience with the treatment (these will be open-ended qualitative questions)
Measured: End of Year 1 of the study
Qualitative treatment experience feedback interview- Year 2 (provider)
30-60 minute semi-structured interviews will be conducted with primary care providers providing FBT-PC and within the participating practices, to assess their experience with the treatment (these will be open-ended qualitative questions)
Measured: End of Year 2 of the study
Qualitative treatment experience feedback interview (caregiver)
Qualitative interviews will be conducted with a purposive combined sample of 10 caregivers from both arms, assessing their experience with both treatments and areas of ongoing need. These will be open-ended qualitative questions.
Measured: At the end of their study participation (up to 6 months)
Qualitative treatment experience feedback interview (patient)
Qualitative interviews will be conducted with a purposive combined sample of 10 patients from both arms, assessing their experience with both treatments and areas of ongoing need. These will be open-ended qualitative questions.
Measured: At the end of their study participation (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Sep 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jocelyn R. Lebow, Mayo Clinic
- Investigators
- Jocelyn Lebow, PhD, LP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814653
- Sponsor's protocol ID
- 22-011880
- Other IDs
- 1R34MH128296-01A1
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of a Primary Care-based Treatment for Restrictive Eating Disorders in Children and Adolescents in the Health System
- ClinicalTrials.gov ID
- NCT05814653
- Acronym / sponsor ID
- 22-011880
- Conditions
- Eating Disorders
- Keywords
- Children and Adolescents
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the feasibility of a RCT of a new treatment for children and adolescents with eating disorders characterized by dietary restriction and/or weight loss or failure to gain expected weight. The treatment, which is called Family-Based Treatment for Primary Care (or FBT-PC for short), is based on Family-Based Treatment, the gold standard outpatient eating disorder treatment for children and adolescents.
Detailed description
In the United States, half a million adolescents suffer from an eating disorder. With only 66 certified providers nationally, Family-Based Treatment (FBT), a first-line evidence-based treatment for adolescent eating disorders, is not readily available to most families. This provider shortage leaves most young patients without care and undoubtedly contributes to the chronicity and lethality of these conditions. Patients with eating disorders generally make their first contact with the healthcare system in primary care. As such, equipping primary care providers (PCPs) with effective means to treat these patients has potential to democratize care, improve rates of early intervention, and enhance patient outcomes. Family-Based Treatment for Primary Care (FBT-PC) is a novel intervention for delivery by a PCP in primary care that uses FBT strategies. Data support proof-of-concept for this adaptation. This study has several study aims. (1) Finalize the FB-PC intervention through an open case series. (2) Establish the feasibility and acceptability of FBT-PC for caregivers, patients, and PCPs in a pilot randomized controlled trial. Finally, (3) to test preliminary target engagement of FBT-PC and determine whether it is associated with improved caregiver self-efficacy and, through this mechanism, symptom remission. Remission will be defined as weight restoration to 95% of expected body weight and a score within 1 SD of community norms on the Eating Disorder Examination-Questionnaire. In addition, as (4) an exploratory aim analyses will be conducted to evaluate baseline characteristics of the sample to determine for whom the FBT-PC intervention is most beneficial. To accomplish all aims an open case series (n = 6) will be conducted, followed by a pilot trial in which 40 patients (ages 7-18 years) with restrictive eating disorders and their caregiver(s) will be randomly assigned to FBT-PC or a control condition of standard FBT. Families will attend up to 18 sessions over 6 months. Goals from the open case series (Aim 1) will include the development of tools for FBT-PC training and implementation, including treatment and training protocols and fidelity measures. Feasibility (Aim 2) will be assessed through an evaluation of recruitment and retention. Acceptability (Aim 2) will be evaluated using mixed methods surveys and interviews of caregivers, patients and PCPs on the topics of tolerability, fit, and burden. The degree to which FBT-PC engages the proposed mechanism of change, caregiver self-efficacy, to facilitate symptom remission will also be assessed (Aim 3). Effect sizes will be calculated for FBT-PC with a goal of ≥ 0.5, comparable with those found in FBT trials. Finally, baseline sample characteristics (Exploratory Aim) will be assessed including caregiver perceptions about their child's illness, referral method, length of illness, and symptom severity. Once feasibility, acceptability, and target engagement of the FBT-PC intervention have been established, these findings will be used in support of a large pragmatic clinical trial to evaluate the noninferiority of effectiveness of FBT-PC versus standard FBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FBT-PC delivered by a primary care provider | Experimental | Behavioral: Family Based Treatment-Primary CareSubjects will receive up to 18 sessions of FBT-PC, delivered by a primary care provider, at their primary care clinic over 6 months. |
| Standard FBT | Active comparator | Behavioral: Family-Based TreatmentSubjects will receive up to 18 session of FBT, delivered by a specialist mental health provider at Mayo Clinic in Rochester, MN over 6 months. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of a DSM-5 restrictive eating disorder (anorexia nervosa or other specified feeding or eating disorder characterized by dietary restriction and/or weight loss or failure to make expected weight gains).
- Eligible patients will have at least one caregiver who is also willing to participate in the study.
- Eligible patients must receive primary care through the MCHS
Key exclusion criteria (3 listed)
- Patients will be excluded who have received FBT in the past, and/or who report active suicidality.
- Patients who become physically or psychiatrically unstable during the study will be re-evaluated and referred for appropriate treatment.
- Patients will be excluded if their enrolled caregiver has active substance dependence, mental health concerns that make it difficult to engage in treatment, or are perpetrators of abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Based Treatment-Primary CareAlso: FBT-PCNovel treatment that borrows key intervention strategies from standard family-based treatment. It uses trained primary care providers (PCPs), in consultation with a mental health provider, to deliver family-based treatment strategies in community-based clinics to increase caregiver self-efficacy to reverse their child's dietary restriction and weight loss. | Behavioural | FBT-PC delivered by a primary care provider |
| Family-Based TreatmentAlso: FBTDelivered by a mental health provider in a traditional mental health or eating disorder specialty setting. First-line evidence-based treatment for adolescent eating disorders that targets caregiver self-efficacy as a mechanism to facilitate weight restoration and ultimately symptom remission in adolescents. | Behavioural | Standard FBT |
Primary outcome
Rate of recruitment across 3 years
Time frame: Rate of recruitment at end of study (3 years)
Recruitment rate will be tracked, with a goal of enrollment of 75% of eligible participants.
Rate of retention across 3 years
Time frame: Rate of retention at end of study (3 years)
Retention rate will be tracked, with a target retention rate (attendance at >80% of sessions) of 70%.
Mixed methods feedback survey at end of treatment (caregiver/patient)
Time frame: Assessed after the final session (within 6 months)
This is a unique survey with quantitative (Likert scale rating/ yes/no questions) and qualitative (short answer) questions that assesses treatment satisfaction, acceptability of session frequency, length, and therapeutic alliance, as well as comfort and familiarity with treatment intervention components. Higher scores on Likert scales indicate greater satisfaction/acceptability.
Rate of retention across 3 years
Time frame: Rate of retention at end of study (3 years)
Rate of retention (defined as attendance at > 80% of sessions) will be tracked, with a target of <30% attrition.
10 secondary outcomes
Parents versus Anorexia Scale (caregiver)
Time frame: Monthly across the intervention (up to 6 months)
Parent Sense of Competency Scale (caregiver)
Time frame: Monthly across the intervention (up to 6 months)
Eating Disorder Symptom Reduction (patient)
Time frame: Pre/post intervention (up to 6 months)
Internalized Stigma of Mental Illness Scale (caregiver/patient)
Time frame: Pre/post intervention (up to 6 months)
Treatment experience feedback survey- Year 1 (provider)
Time frame: End of Year 1 of the study
Treatment experience feedback survey- Year 2 (provider)
Time frame: End of Year 2 of the study
Qualitative treatment experience feedback interview- Year 1 (provider)
Time frame: End of Year 1 of the study
Qualitative treatment experience feedback interview- Year 2 (provider)
Time frame: End of Year 2 of the study
Qualitative treatment experience feedback interview (caregiver)
Time frame: At the end of their study participation (up to 6 months)
Qualitative treatment experience feedback interview (patient)
Time frame: At the end of their study participation (up to 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jocelyn Lebow, PhD, LP principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Based Treatment-Primary Care and Family-Based Treatment in people with Eating Disorders, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment across 3 years (time frame: Rate of recruitment at end of study (3 years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.