Bulimia NervosaNCT05911334
Feasibility of the ROADE Program
A study testing ROADE Program in people with Bulimia Nervosa and Anorexia Nervosa, run by University of New Mexico at 1 site in United States.
Trial summary
Occupational therapy is uniquely poised to help address chronic Eating Disorders (EDs) because of our holistic approach to client care. The complex and serious nature of EDs spans so many areas of life and wellbeing, it requires an intervention strategy that addresses the whole person across mental, physical, social… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Bulimia Nervosa, Anorexia Nervosa, Binge-Eating Disorder
- What is being tested?
- ROADE Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 19 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with Binge Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, or ARFID
- Able to answer surveys in English
- 14 years of age or older
Who cannot join
- Unable to comfortably do light exercise such as Yoga
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: Assessing the Feasibility of the Restorative Occupational Approaches for Disordered Eating (ROADE) Program
Occupational therapy is uniquely poised to help address chronic Eating Disorders (EDs) because of our holistic approach to client care. The complex and serious nature of EDs spans so many areas of life and wellbeing, it requires an intervention strategy that addresses the whole person across mental, physical, social, and spiritual realms. Unfortunately, specialized care for EDs can be difficult to find - especially for those not sick enough to be admitted to an inpatient facility but who are still struggling to thrive in daily life. For example, in New Mexico there is only one inpatient treatment center for EDs and no specialized outpatient services. This leaves many people suffering from EDs without options for care because they are not yet sick enough. There is a need for novel interventions in this setting that go beyond the traditional weight and food-focused medical interventions and seek to help empower individuals, work around challenges, and live their lives to the fullest.
To meet this need in our community, the study team is developing a preliminary outpatient treatment program. The ROADE (Restorative Occupational Approaches for Disordered Eating) Program is an 8-week, structured, multimodal intervention seeking to reduce psychosocial symptoms and improve self-management skills for disordered eating. The intervention strategies range from: (1) wellness activities like mindfulness meditation to improve interoception, self-acceptance, and as a self-guided coping tool (2) adaptation of health management and self-care occupations to improve daily functioning while navigating ongoing disordered eating symptoms and (3) light exercise like Yoga and lymphatic drainage exercises to reconnect in a positive way with the body, improve digestion, promote relaxation, and reduce muscle tension. The current research investigates the feasibility and acceptability of this intervention while testing preliminary effects on eating disorder symptoms.
Read the detailed description
Eating Disorders (ED) are pervasive, long-lasting conditions that are exceptionally destructive to wellbeing and many areas of occupational performance. In the United States an estimated 29 million individuals will suffer from an eating disorder across their lifespan (Academy for Eating Disorders, 2020) with the most common diagnoses being Anorexia Nervosa, Binge Eating Disorder, Bulimia Nervosa, and Avoidant, Restrictive, Food Intake Disorder (ARFID). Though distinct, each of these diagnoses share a feature of individuals developing a dysfunctional relationship with food that is rigid and ritualized. The point prevalence of all eating disorders combined appears to be on the rise worldwide, increasing from an estimated 4% to 8% of the population starting in the year 2000 through 2018 (Galmiche, 2019). Often this is accompanied with compulsive routines that exhaust many hours a day. Beyond disrupted eating, symptoms span almost all areas of occupation (e.g., hygiene, social functioning, work, rest) and affect both mental health and physical health (Bradford et al., 2015).
Unfortunately, with current treatments for eating disorders, the long-term outcomes are poor. Recovery can be a long process, often taking 6 years or more (Franco, 2017), but this is likely an underestimate due to the limited length of research follow up (Arcelus et al., 2011). Estimates of recovery and mortality range greatly depending on the source with as much as half of individuals not recovering fully and up to an astounding 5% of those afflicted with Anorexia Nervosa dying from the disorder (Franko et al., 2013). Sadly, 1 in 5 deaths from Anorexia Nervosa result from suicide while predictors of higher mortality include alcohol misuse and other comorbid mental health diagnoses (Arcelus et al., 2011). Multiple systematic reviews report that current interventions have yet to demonstrate strong effect sizes and there is no one specific approach that has emerged as best practice (Kotilahti et al., 2020; Murray et al., 2018; Peat et al., 2017; Zeeck et al., 2018). There is a call to move beyond a simplistic treatment model that over-emphasizes weight gain or loss and instead more fully addresses personal and social effects of the disorder, uses harm reduction strategies, and strives to empower clients (Hay et al., 2012).
The present project addresses the serious, complex, and enduring nature of eating disorders. Occupational therapy is uniquely poised to help address chronic EDs because of our holistic approach to client care. As eating disorders affect myriad areas of health and wellbeing, they require intervention strategies that addresses the whole person across mental, physical, and social realms. Specialized care for EDs can be difficult to find. This is especially true for those not sick enough to be admitted to an inpatient facility but who are still struggling to thrive in daily life. Specific to the state of New Mexico, where the project will be conducted, there are currently no outpatient mental health services that specialize in treating eating disorders. Individuals may succeed in graduating from the single in-patient eating disorder clinic in our state, but are discharged without a strong outpatient program to follow their care. This presents a large risk of relapse. Our hope is that ROADE Program will eventually grow into a resource for the community and help bridge this gap in services. More broadly, the present project has the opportunity to build a role for occupational therapists in treating eating disorders and expand our role in chronic illness management.
Occupational therapy interventions in this setting, to our knowledge, have yet been evaluated experimentally. Much of the publications in occupational therapy about eating disorder treatment is older evidence or relies on expert opinion and nonsystematic literature review to describe potential avenues for intervention (e.g. Bradford et al., 2015; Clark \& Nayar, 2012; Gardener \& Brown, 2010; Horner, 2006). One occupational therapy text in mental health (Crouch \& Alers, 2014), one survey of occupational therapists working in mental health settings (Klockzko \& Ikiugu, 2006), and a small subjective study that polled participants opinion about the helpfulness of the intervention (Biddiscombe et al., 2018) demonstrate that occupational therapy self-identifies as having a role in treating eating disorders. Key points of interest for from these perspectives are that occupational therapists should work in a collaborative model with other healthcare providers, use a holistic approach to care, and focus on the areas of occupation that are affected by the disorder. With this emerging level of evidence, the study team has developed one such program from the ground up. Our preliminary take on developing an intervention used best available evidence from within occupational therapy, but also draws from outside the profession. We focused on restorative approaches fitting within the occupational therapy practice area based on the OT Practice Framework (AOTA, 2020). This became the ROADE (Restorative Occupational Approaches for Disordered Eating) Program.
The ROADE Program is to our knowledge the first of its kind being an occupational-therapy-specific intervention for disordered eating. In its current form it is an 8-week, structured, multimodal intervention seeking to reduce psychosocial symptoms and improve self-management skills for disordered eating. The intervention strategies range from: (1) Light exercises and Yoga to improve lymphatic drainage, improve digestion, promote relaxation, and reduce muscle tension (Gibson \& Mehler, 2019; Moser, 2020; Sim et al, 2017; Souza et al, 2018), (2) mindfulness meditation to improve interoception, self-acceptance, and as a self-guided coping tool (Sala et al., 2020), and (3) adaptation of health management and self-care occupations to improve daily functioning while navigating ongoing disordered eating symptoms (Crouch \& Alers, 2014; Sørlie et al., 2020). It is our hope to further hone this program into a manualized intervention, track the preliminary effects of the intervention, collect feasibility data points, and then seek funding for an efficacy trial. These objectives will be explored in the form of three specific aims:
Specific Aim 1. To establish the feasibility of implementing the ROADE Program in a research setting Specific Aim 2. To determine the preliminary effects the ROADE Program intervention has on disordered eating symptoms.
Specific Aim 3. To hone the ROADE Program protocol by leveraging expert guidance, training, and experience.
- Conditions
- Bulimia Nervosa, Anorexia Nervosa, Binge-Eating Disorder, Avoidant/Restrictive Food Intake Disorder
- Being tested
- ROADE Program
- Keywords
- Occupational Therapy, Chronic Illness Management, Eating Disorder, Yoga, Mindfulness
- Medical subject headings
- Bulimia Nervosa, Anorexia Nervosa, Binge-Eating Disorder, Avoidant Restrictive Food Intake Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROADE ProgramBehavioural
Outpatient Behavioral Intervention for Eating Disorder
| Study group | Role | What they receive |
|---|---|---|
| Restorative Occupational Approaches for Disordered Eating (ROADE) | Experimental | Novel Outpatient Occupational Therapy Intervention using chronic illness management strategies, yoga, meditation for disordered eating. 8-weeks with 2 visits per week each lasting 1 hour. Receives: Behavioral: ROADE Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown-Cornell Eating Disorder Scale
Eating Disorder Symptom Burden
Measured: 8 weeks
Secondary outcomes (2)
Beck Anxiety Inventory
Self-reported Anxiety
Measured: 8 weeks
SF-36
health-related quality of life
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Oct 2023
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Why it stopped: The ROADE grant was terminated early by C\&G and the PI left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911334
- Sponsor's protocol ID
- STUDY00006140
- Other IDs
- AOTFIRG23Hardison
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of the Restorative Occupational Approaches for Disordered Eating (ROADE) Program
- ClinicalTrials.gov ID
- NCT05911334
- Acronym / sponsor ID
- STUDY00006140
- Conditions
- Bulimia Nervosa, Anorexia Nervosa, Binge-Eating Disorder, Avoidant/Restrictive Food Intake Disorder
- Keywords
- Occupational Therapy, Chronic Illness Management, Eating Disorder, Yoga, Mindfulness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The ROADE grant was terminated early by C\&G and the PI left the institution.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 22 Jun 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.
Occupational therapy is uniquely poised to help address chronic Eating Disorders (EDs) because of our holistic approach to client care. The complex and serious nature of EDs spans so many areas of life and wellbeing, it requires an intervention strategy that addresses the whole person across mental, physical, social, and spiritual realms. Unfortunately, specialized care for EDs can be difficult to find - especially for those not sick enough to be admitted to an inpatient facility but who are still struggling to thrive in daily life. For example, in New Mexico there is only one inpatient treatment center for EDs and no specialized outpatient services. This leaves many people suffering from EDs without options for care because they are not yet sick enough. There is a need for novel interventions in this setting that go beyond the traditional weight and food-focused medical interventions and seek to help empower individuals, work around challenges, and live their lives to the fullest.
To meet this need in our community, the study team is developing a preliminary outpatient treatment program. The ROADE (Restorative Occupational Approaches for Disordered Eating) Program is an 8-week, structured, multimodal intervention seeking to reduce psychosocial symptoms and improve self-management skills for disordered eating. The intervention strategies range from: (1) wellness activities like mindfulness meditation to improve interoception, self-acceptance, and as a self-guided coping tool (2) adaptation of health management and self-care occupations to improve daily functioning while navigating ongoing disordered eating symptoms and (3) light exercise like Yoga and lymphatic drainage exercises to reconnect in a positive way with the body, improve digestion, promote relaxation, and reduce muscle tension. The current research investigates the feasibility and acceptability of this intervention while testing preliminary effects on eating disorder symptoms.
Detailed description
Eating Disorders (ED) are pervasive, long-lasting conditions that are exceptionally destructive to wellbeing and many areas of occupational performance. In the United States an estimated 29 million individuals will suffer from an eating disorder across their lifespan (Academy for Eating Disorders, 2020) with the most common diagnoses being Anorexia Nervosa, Binge Eating Disorder, Bulimia Nervosa, and Avoidant, Restrictive, Food Intake Disorder (ARFID). Though distinct, each of these diagnoses share a feature of individuals developing a dysfunctional relationship with food that is rigid and ritualized. The point prevalence of all eating disorders combined appears to be on the rise worldwide, increasing from an estimated 4% to 8% of the population starting in the year 2000 through 2018 (Galmiche, 2019). Often this is accompanied with compulsive routines that exhaust many hours a day. Beyond disrupted eating, symptoms span almost all areas of occupation (e.g., hygiene, social functioning, work, rest) and affect both mental health and physical health (Bradford et al., 2015).
Unfortunately, with current treatments for eating disorders, the long-term outcomes are poor. Recovery can be a long process, often taking 6 years or more (Franco, 2017), but this is likely an underestimate due to the limited length of research follow up (Arcelus et al., 2011). Estimates of recovery and mortality range greatly depending on the source with as much as half of individuals not recovering fully and up to an astounding 5% of those afflicted with Anorexia Nervosa dying from the disorder (Franko et al., 2013). Sadly, 1 in 5 deaths from Anorexia Nervosa result from suicide while predictors of higher mortality include alcohol misuse and other comorbid mental health diagnoses (Arcelus et al., 2011). Multiple systematic reviews report that current interventions have yet to demonstrate strong effect sizes and there is no one specific approach that has emerged as best practice (Kotilahti et al., 2020; Murray et al., 2018; Peat et al., 2017; Zeeck et al., 2018). There is a call to move beyond a simplistic treatment model that over-emphasizes weight gain or loss and instead more fully addresses personal and social effects of the disorder, uses harm reduction strategies, and strives to empower clients (Hay et al., 2012).
The present project addresses the serious, complex, and enduring nature of eating disorders. Occupational therapy is uniquely poised to help address chronic EDs because of our holistic approach to client care. As eating disorders affect myriad areas of health and wellbeing, they require intervention strategies that addresses the whole person across mental, physical, and social realms. Specialized care for EDs can be difficult to find. This is especially true for those not sick enough to be admitted to an inpatient facility but who are still struggling to thrive in daily life. Specific to the state of New Mexico, where the project will be conducted, there are currently no outpatient mental health services that specialize in treating eating disorders. Individuals may succeed in graduating from the single in-patient eating disorder clinic in our state, but are discharged without a strong outpatient program to follow their care. This presents a large risk of relapse. Our hope is that ROADE Program will eventually grow into a resource for the community and help bridge this gap in services. More broadly, the present project has the opportunity to build a role for occupational therapists in treating eating disorders and expand our role in chronic illness management.
Occupational therapy interventions in this setting, to our knowledge, have yet been evaluated experimentally. Much of the publications in occupational therapy about eating disorder treatment is older evidence or relies on expert opinion and nonsystematic literature review to describe potential avenues for intervention (e.g. Bradford et al., 2015; Clark \& Nayar, 2012; Gardener \& Brown, 2010; Horner, 2006). One occupational therapy text in mental health (Crouch \& Alers, 2014), one survey of occupational therapists working in mental health settings (Klockzko \& Ikiugu, 2006), and a small subjective study that polled participants opinion about the helpfulness of the intervention (Biddiscombe et al., 2018) demonstrate that occupational therapy self-identifies as having a role in treating eating disorders. Key points of interest for from these perspectives are that occupational therapists should work in a collaborative model with other healthcare providers, use a holistic approach to care, and focus on the areas of occupation that are affected by the disorder. With this emerging level of evidence, the study team has developed one such program from the ground up. Our preliminary take on developing an intervention used best available evidence from within occupational therapy, but also draws from outside the profession. We focused on restorative approaches fitting within the occupational therapy practice area based on the OT Practice Framework (AOTA, 2020). This became the ROADE (Restorative Occupational Approaches for Disordered Eating) Program.
The ROADE Program is to our knowledge the first of its kind being an occupational-therapy-specific intervention for disordered eating. In its current form it is an 8-week, structured, multimodal intervention seeking to reduce psychosocial symptoms and improve self-management skills for disordered eating. The intervention strategies range from: (1) Light exercises and Yoga to improve lymphatic drainage, improve digestion, promote relaxation, and reduce muscle tension (Gibson \& Mehler, 2019; Moser, 2020; Sim et al, 2017; Souza et al, 2018), (2) mindfulness meditation to improve interoception, self-acceptance, and as a self-guided coping tool (Sala et al., 2020), and (3) adaptation of health management and self-care occupations to improve daily functioning while navigating ongoing disordered eating symptoms (Crouch \& Alers, 2014; Sørlie et al., 2020). It is our hope to further hone this program into a manualized intervention, track the preliminary effects of the intervention, collect feasibility data points, and then seek funding for an efficacy trial. These objectives will be explored in the form of three specific aims:
Specific Aim 1. To establish the feasibility of implementing the ROADE Program in a research setting Specific Aim 2. To determine the preliminary effects the ROADE Program intervention has on disordered eating symptoms.
Specific Aim 3. To hone the ROADE Program protocol by leveraging expert guidance, training, and experience.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restorative Occupational Approaches for Disordered Eating (ROADE) | Experimental | Behavioral: ROADE ProgramNovel Outpatient Occupational Therapy Intervention using chronic illness management strategies, yoga, meditation for disordered eating. 8-weeks with 2 visits per week each lasting 1 hour. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Binge Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, or ARFID
- Able to answer surveys in English
- 14 years of age or older
Key exclusion criteria (1 listed)
- Unable to comfortably do light exercise such as Yoga
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 |
|---|---|---|
| ROADE ProgramOutpatient Behavioral Intervention for Eating Disorder | Behavioural | Restorative Occupational Approaches for Disordered Eating (ROADE) |
Primary outcome
Yale-Brown-Cornell Eating Disorder Scale
Time frame: 8 weeks
Eating Disorder Symptom Burden
2 secondary outcomes
Beck Anxiety Inventory
Time frame: 8 weeks
SF-36
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: The ROADE grant was terminated early by C\&G and the PI left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROADE Program in people with Bulimia Nervosa and Anorexia Nervosa, run by University of New Mexico 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 1 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: stopped early, as of the sponsor's last update on 18 Jun 2024. 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?
The study was stopped early (reason given: The ROADE grant was terminated early by C\&G and the PI left the institution.). Results are not available in the source record.
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?
Yale-Brown-Cornell Eating Disorder Scale (time frame: 8 weeks). 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 18 Jun 2024.