Feasibility of the ROADE Program

NCT05911334 | Terminated

• 2 other identifiers: STUDY00006140AOTFIRG23Hardison
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Bulimia Nervosa; Anorexia Nervosa; Binge-Eating Disorder; Avoidant/Restrictive Food Intake Disorder

Keywords

Occupational Therapy; Chronic Illness Management; Eating Disorder; Yoga; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Yale-Brown-Cornell Eating Disorder Scale

  Eating Disorder Symptom Burden

  8 weeks

Secondary Outcomes (2)

• Beck Anxiety Inventory

  8 weeks

• SF-36

  8 weeks

Study Arms (1)

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.

Behavioral: ROADE Program

Interventions

ROADE Program BEHAVIORAL

Outpatient Behavioral Intervention for Eating Disorder

Restorative Occupational Approaches for Disordered Eating (ROADE)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Binge Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, or ARFID
• Able to answer surveys in English
• years of age or older

You may not qualify if:

• Unable to comfortably do light exercise such as Yoga

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Bulimia Nervosa; Anorexia Nervosa; Binge-Eating Disorder; Avoidant Restrictive Food Intake Disorder; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 22, 2023
• Study Start: October 1, 2023
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

US (1)