Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 31, 2022
Date Accepted: Nov 24, 2022
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Virtually Delivered Dietary Interventions for Patients with Eating Disorders Undergoing Family Based Treatment: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Eating disorders (EDs) affect 9% of the United States population, and anorexia nervosa (AN), specifically, has the second highest mortality rate of all psychiatric disorders. The COVID-19 pandemic has resulted in rising prevalence estimates and exacerbation of ED behaviors and comorbid psychiatric issues. Pre-pandemic access to care issues were thus compounded by long wait lists, lack of trained specialists, financial and geographic barriers, all of which highlight the need for effective telehealth interventions. Family-based therapy (FBT) is a first-line treatment for adolescents and young adults with ED's, though geographic barriers and dearth of trained specialists contribute to challenges with access. Further, weight gain early in treatment is considered a primary predictor of success with FBT, and is predictive of best prognosis. However, nutrition requirements for patients with ED’s are uniquely complex. A variety of dietary interventions for guiding the renourishment process are used in practice, but empirical data on the effectiveness of the various interventions is sparse. The significance of nutritional restoration and issues with access to first-line treatments underscore the need for further research comparing virtually delivered dietary interventions.
Objective:
Our objective is to compare effectiveness and acceptability of two virtually-delivered dietary interventions frequently used in eating disorder treatment settings: 1) Calorie-based meal plans and 2) Plate-by-PlateTM (PBP) approach. Specifically, we will explore any potential differences in the rate of weight restoration achieved over 8 weeks of treatment, as well as additional treatment outcomes (e.g., ED symptoms, anxiety, depression), caregiver burden, and perceived ease of use and efficacy for both caregivers and clinicians.
Methods:
Patients with either anorexia nervosa (AN) or avoidant restrictive food intake disorders (ARFID) ages 6-24 seeking treatment at Equip Health, a nationwide virtual eating disorder treatment program, were enrolled beginning in May 2022. We will continue rolling enrollment until we reach a minimum N=80. Upon admission, patients are randomly assigned to receive either the calorie-based intervention or Plate-by-Plate™ approach from their registered dietitian, all of whom have received training as telehealth study interventionists. Primary outcomes of interest will be collected during the first 8 weeks of treatment, though patients will be followed for up to 12-months. Descriptive statistics will be used to describe patient characteristics and demographics. Rate of weight change and other treatment outcomes between groups will be compared using generalized linear models in R version 4.1.1. Semi-structured interview transcripts will undergo qualitative analysis.
Results:
Data collection for this study began in May 2022, and we anticipate completion of data collection in November of 2022. We plan to complete analysis in December 2022.
Conclusions:
To our knowledge, this will be the first RCT comparing virtually-delivered dietary interventions for treatment of ED’s. Upon study completion, we hope to add to the growing body of evidence supporting FBT by identifying any potential differences between interventions in effectiveness, acceptability, and ease of use.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.