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Individuals with disabilities living with chronic health conditions require self-management programs that are accessible, sustainable, inclusive, and adaptable. Health coaching is an effective approach to promoting behavior change in self-management. Health coaching combined with telehealth technology has the potential to improve the overall quality of, and access to, health services.
This protocol outlines the study design for implementing the My Health, My Life, My Way intervention. The study will assess the feasibility, acceptability, and preliminary efficacy of the intervention for people with disabilities and optimize it.
The My Health, My Life, My Way study is a 4-arm randomized controlled trial evaluating the delivery of a 6-month intervention involving telecoaching, inclusive educational content, and technology access for 200 individuals with chronic conditions and physical disabilities. This study uses the engineering-inspired multiphase optimization strategy (MOST) framework to evaluate intervention components and assess whether a combination or lack of individual elements influences behavior. Participants will be randomized to 1 of 4 study arms: scheduled coaching calls and gamified rewards, no scheduled coaching calls and gamified rewards, scheduled coaching calls and flat rewards, and no scheduled coaching calls and flat rewards.
The My Health, My Life, My Way study was approved by the institutional review board of the University of Alabama at Birmingham, and recruitment and enrollment will begin in May 2023. Data analysis is expected to be completed within 6 months of ending data collection. This clinical trial protocol was developed based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement.
The My Health, My Life, My Way study will help to optimize and improve our understanding of the feasibility and efficacy of a web-based self-management program for people with physical disabilities and chronic conditions. More specifically, My Health, My Life, My Way will determine which combination of interventions (coaching calls and gamification) will result in increased participation in self-management programming. The My Health, My Life, My Way intervention has the potential to become a scalable and novel method to successfully manage chronic conditions in people with disabilities.
ClinicalTrials.gov NCT05481593; https://clinicaltrials.gov/ct2/show/NCT05481593
PRR1-10.2196/31694
The Centers for Disease Control and Prevention (CDC) defines chronic diseases as conditions that last ≥1 year and require ongoing medical attention or limit activities of daily living or both. In the United States, 6 in 10 adults are reported to have at least 1 chronic condition, whereas 4 in 10 adults are reported to have ≥2 chronic conditions [
Although physical disabilities increase the risk of developing chronic conditions, the inverse also occurs [
Current science has enabled multiple approaches to managing chronic disease conditions [
Within these programs, multiple approaches have been used to implement self-management programs. Health coaching is one of the most common and cost-effective mechanisms of delivering self-management programming [
Although self-management programs are effective for behavior change in managing health conditions, individuals with physical disabilities who also experience chronic conditions lack inclusive and accessible self-management programming to positively affect their own behavior change. People with disabilities experience barriers that are different from those experienced by people without physical disabilities, including nutritional and dietary concerns, as well as barriers to physical activity (PA) participation. More specifically, these barriers include lack of accessible environments, appropriate equipment (eg, wheelchair accessibility), and low health literacy and knowledge [
In the goal to improve chronic disease management for people with disabilities, we propose the development of an inclusive telecoaching self-management program. To make the telecoaching approach sustainable and scalable, artificial intelligence techniques are used to reduce the time that health coaches spend communicating with each participant.
This study is structured to serve as the optimization phase of the multiphase optimization strategy (MOST) framework and involves efficient randomized experimentation to estimate the effectiveness of individual intervention components and identify the optimal intervention package to improve the primary outcome, health-related quality of life after 6 months [
Telehealth programs provide several advantages for individuals who want to improve their overall health and promote positive behavior change [
Gaming technologies have displayed a high level of adherence and engagement characteristics, and this has led to the gamification of telehealth interventions. Gamification refers to the use of game design elements in nongame contexts and is being used across a variety of telehealth interventions to promote treatment adherence [
Telehealth intervention studies typically use randomized controlled trial designs. However, telehealth interventions are comprehensive packages that include components such as coaching calls, educational content, texting, email, and mobile apps. Randomized controlled trials fail to reveal which components are responsible for any behavior change elicited during the intervention; rather, they only show whether the intervention package as a whole had any effect. Therefore, it is necessary to know which elements of telehealth interventions are needed or should be removed for a more efficient telehealth intervention. To optimize the My Health, My Life, My Way program, the MOST framework will be used to assess which study elements (coaching calls and gamification) elicit behavior change. The MOST framework, derived from engineering principles, is an efficient method to gather information on each intervention component or package and investigate whether the presence or absence of a component has an impact on the performance of other components [
The My Health, My Life, My Way study is a 2 × 2 randomized factorial experiment. By using the MOST framework, we can evaluate the effectiveness of different combinations of features within the My Health, My Life, My Way program, such as fixed versus gamified rewards and scheduled versus on-demand coaching calls. Eligible participants will be randomly assigned to one of four groups: (1) scheduled coaching calls with gamified rewards, (2) scheduled coaching calls with rewards independent of gamification, (3) no scheduled coaching calls with gamified rewards, and (4) no scheduled coaching calls with rewards independent of gamification (
Research design.
Gamified rewards | Coaching calls | |
|
Scheduled coaching calls | No scheduled coaching calls |
Gamification-based rewards | Scheduled coaching calls with gamified rewards | No scheduled coaching calls with gamified rewards |
Rewards independent of gamification | Scheduled coaching calls with rewards independent of gamification | No scheduled coaching calls with rewards independent of gamification |
We will use a 2 × 2 factorial design for this MOST trial (detailed in the Intervention Design subsection). Our sample size and power calculations for the primary outcome (health-related quality of life) assume an overall 2-sided type I error rate of 5%, 80% power, and an analysis of covariance–based approach with 2 independent dichotomous factors (ie, each factor has 2 levels). We will assume an attrition rate of 20%, with 160 (80%) participants completing the study (referred to as completers) from 200 participants enrolled. Under these assumptions, we will have 80% power to detect at least a minimally detectable difference (Cohen
Recruitment will be conducted on the web nationally through the National Center on Health, Physical Activity and Disability (NCHPAD) website and its associated social media. The NCHPAD website has approximately 45,000 site visits per month, with most of the internet traffic flowing from the United States (74%). Through these mechanisms, interested individuals will be directed to a website landing page that will have promotional media content and information about the study. From here, participants will be directed to a separate link through the Health Insurance Portability and Accountability Act (HIPAA)–compliant REDCap (Research Electronic Data Capture; Vanderbilt University) platform [
Participants will be randomized into 1 of 4 study arms in a 1:1:1:1 allocation ratio using a computer-generated randomization procedure. The allocation sequence will be implemented after the baseline survey is completed. The computer-generated randomization process will be implemented in REDCap after the data from the baseline survey are completed using REDCap. This will trigger the allocation procedure to randomly assign participants to 1 of the 4 study arms. The health coach will be notified about the randomization through the telecoaching dashboard and will inform the participants about their randomization into the My Health, My Life, My Way intervention or the attention control arm during the orientation call.
The principal investigator and primary statistician will be blinded to the randomization of the participants into the study arms. All other study staff will be unblinded for purposes of recruitment, consent, orientation calls, welcome calls, and coaching calls. There are no circumstances in which the principal investigator or statistician will become unblinded during this protocol.
Eligible participants must meet the following inclusion criteria: (1) aged ≥18 years; (2) self-reported diagnosis of heart disease, chronic lung disease, hypertension, or type 2 diabetes; (3) living with a permanent physical disability such as spinal cord injury, spina bifida, multiple sclerosis, or stroke; (4) speak and read English; and (5) availability of a smartphone or computer. To screen for permanently impaired mobility, we will use the National Health and Nutrition Examination Survey (NHANES; physical functioning) [
The exclusion criteria are as follows: (1) current enrollment in any structured intervention, (2) severe cognitive impairment, (3) major cardiac event in the past 12 months, (4) resting tachycardia, (5) renal failure, (6) severe peripheral neuropathy, (7) active treatment for cancer in the past 12 months, and (8) having both visual and hearing impairments (either is acceptable).
The study duration for those enrolled in the study will be 6 months (24 weeks), regardless of study arm allocation. Participants assigned to groups with scheduled coaching calls will receive scheduled weekly coaching calls. Those assigned to a group without scheduled coaching calls will have access to health coaches during the study and be able to communicate with the health coaches as needed.
After enrolling in the study, participants will automatically be electronically delivered a REDCap link to a survey packet. This survey packet will include demographics and outcome measures (
Measures of effectiveness.
Variablesa | Instruments | Time points |
Health-related quality of life | Enabled version of 36-item Short Form Health Survey (primary outcome) | Baseline, 3 months, and 6 months |
Physical activity | Godin Leisure-Time Exercise Questionnaire | Baseline, 3 months, and 6 months |
Physical activity | Minutes, steps, and related data from Fitbit | Continuous |
SEb for managing symptoms | PROMISc Item Bank v1.0–Self-Efficacy for Managing Chronic Conditions–Managing Symptoms–Short Form 4a | Baseline, 3 months, and 6 months |
SE for managing daily activities | PROMIS Item Bank v1.0–Self-Efficacy for Chronic Conditions–Managing Daily Activities–Short Form 4a | Baseline, 3 months, and 6 months |
SE for managing sleep disturbance | PROMIS Item Bank v1.0–Sleep Disturbance–Short Form 4a | Baseline, 3 months, and 6 months |
Psychosocial Illness | PROMIS Item Bank v1.0–Psychosocial Illness Impact-Positive–Short Form 8a | Baseline, 3 months, and 6 months |
SE for managing emotions | PROMIS Item Bank v1.0–Self-Efficacy for Managing Chronic Conditions–Managing Emotions–Short Form 4a | Baseline, 3 months, and 6 months |
SE for managing social interactions | PROMIS Item Bank v1.0–Self-Efficacy for Managing Chronic Conditions–Managing Social Interactions–Short Form 4a | Baseline, 3 months, and 6 months |
Emotional distress | PROMIS Item Bank v1.0–Emotional Distress-Depression–Short Form 4a | Baseline, 3 months, and 6 months |
SE for managing medications and treatments | PROMIS Item Bank v1.0–Self-Efficacy for Managing Chronic Conditions–Managing Medication and Treatment–Short Form 4a | Baseline, 3 months, and 6 months |
SE for managing sleep-related impairments | PROMIS Short Form v1.0–Sleep-Related Impairment–Short Form 4a | Baseline, 3 months, and 6 months |
Dietary intake | Short Healthy Eating Index | Baseline, 3 months, and 6 months |
Medication adherence | Medication Adherence Rating Scale and Beliefs About Medication Questionnaire | Baseline, 3 months, and 6 months |
Usability | Health Information Usability Evaluation Scale and System Usability Scale | Three months and 6 months |
aIn addition to the variables listed in the table, primary care visits, pharmacy visits, physical therapy and occupational therapy visits, emergency visits, and hospitalizations in the last 3 months (self-reported) will also be taken into account.
bSE: self-efficacy.
cPROMIS: Patient-Reported Outcomes Measurement Information System.
After the first survey packet is electronically delivered to participants, study team members will contact the participants by telephone. The purpose of this call is to welcome them into the program and explain the program elements. During the call, the staff will inform the participants that they will receive a technology package in the upcoming days.
A randomization sequence will be generated and stored within REDCap, which assigns a participant to 1 of the 4 study arms of the My Health, My Life, My Way study. Randomization will occur only after the baseline survey packet is complete.
After the welcome call and randomization, a study health coach will be notified through REDCap that a participant has been randomized to one of the study arms and will conduct an orientation call with the participant. The purpose of this call by the health coach is to introduce themselves to the participants as their primary health coach and to schedule the first weekly coaching call. For those not receiving scheduled coaching calls, the health coach will inform participants that they can contact the coaching staff during the study to ask questions related to the educational content provided on the platform.
All participants, regardless of study arm allocation, will receive an intervention package that will include a PA tracker (Fitbit; Google LLC) and access to a telehealth platform. The Fitbit tracker will be shipped to the participants after randomization. The telehealth platform will be a central location for educational content (videos, articles, etc) for participants to access during the study. Those with conversational agents (eg, Amazon Echo) will be provided access to a My Health, My Life, My Way specific program that can operate with their home device. This package will be used for intervention delivery and not for outcome measurements.
The study arms for the My Health, My Life, My Way study with the coaching calls for all groups will be guided by a prepared outline of inclusive educational content that will be delivered to the participants through the telehealth platform. This content will be delivered at the beginning of each week. The educational content will be created and adapted for individuals with physical disabilities by experts and delivered to the participants as multimedia content. There will be generalized educational content applicable to all participants. On the basis of a specific physical disability as well as specific health conditions, education-specific content will be tailored to each individual. For those receiving scheduled coaching calls, the content discussed will include nutrition and eating habits, exercise and PA, and medication adherence. Questions outside the scope of the health coaching content will be dealt with by the study clinician. If the study team determines that the questions indicate that it is necessary to collect a participant’s detailed medical profile, the participant will be guided to communicate with their primary care physician. Finally, the health coach will address other health-related questions that the participant may have. For each call, the health coach will be able to record notes on the telehealth platform regarding topics discussed with the participant for future calls, as needed.
The My Health, My Life, My Way telehealth platform will be used by participants throughout the duration of the study. On the platform, participants will be able to access educational multimedia content (videos and articles), track and log medication use, create and track health-related goals, and access food- and nutrition-related information. In addition, participants will be able to view upcoming health coaching calls and contact the health coaching team using the messaging feature of the platform.
All participants, regardless of gamification variation, will be able to obtain points and badges on the platform. Participants can check their points status at any time during the study by logging in to the platform to view an itemized list for all badges and points. In addition, participants will be provided email notifications for all gamification updates. All activities, such as viewing and reading educational content and logging in to the platform, will automatically be updated on the platform. Health coaches will encourage participants to engage on the platform regularly. Those not receiving scheduled coaching calls who exercise the on-demand coaching option will be encouraged by a health coach to use the platform regularly.
Those receiving scheduled health coaching calls will be able to view upcoming calls on the platform. In addition, email and SMS text messaging notifications will be provided to remind participants of all scheduled coaching calls. Scheduled coaching calls will occur once per week and are expected to last up to 60 minutes. Those who will not receive scheduled coaching calls will still have access to the study platform. Within the platform, participants will be able to contact health coaching staff if they desire on-demand coaching. With this on-demand coaching function, participants can discuss any questions regarding educational content on the platform.
After the study duration, up to 30 participants from the My Health, My Life, My Way program will be contacted for a follow-up interview to obtain their experiences and feedback with the My Health, My Life, My Way telehealth platform. These interviews will be conducted on the web.
Primary and secondary outcome measures will be assessed at baseline, 3 months, and 6 months (after the intervention). The primary clinical outcome measure is health-related quality of life; the secondary outcome measures are described in
The primary outcome measure is health-related quality of life. This will be measured by using the 36-item Short Form Health Survey, enabled version (SF-36E). More specifically, the physical functioning section of the SF-36E has been modified, which uses disability-friendly inclusive language for individuals with mobility impairments [
All other measures, including demographic data and secondary outcome measures, will be retrieved and automatically stored through electronic surveys delivered by REDCap. All self-reported items within the questionnaires will be mandatory to prevent missing data. The questionnaire packet will be delivered electronically to the participants during the study.
To measure PA, participants will complete the Godin Leisure-Time Exercise Questionnaire. This 3-item questionnaire asks questions related to strenuous, moderate, and light exercises performed during the past 7 days [
Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0–Self-Efficacy for Managing Chronic Conditions–Managing Symptoms–Short Form 4a, which is a 4-item survey that assesses confidence in managing symptoms associated with their chronic health condition [
To assess confidence in handling daily activities, participants will complete the 4-item PROMIS Item Bank v1.0–Self-Efficacy for Chronic Conditions–Managing Daily Activities–Short Form 4a [
Participants will complete the PROMIS Item Bank v1.0–Sleep Disturbance–Short Form 4a, which is a 4-item survey that evaluates sleeping habits during the previous 7 days [
To assess self-efficacy for managing psychosocial illness, participants will complete the PROMIS Psychosocial Illness Impact-Positive–Short Form 8a [
To assess the ability to manage emotions, participants will complete the PROMIS Item Bank v1.0–Self-Efficacy for Managing Chronic Conditions–Managing Emotions–Short Form 4a [
Participants will complete the PROMIS Item Bank v1.0–Self-Efficacy for Managing Chronic Conditions–Managing Social Interactions–Short Form 4a [
To assess self-efficacy for managing depression, participants will complete the PROMIS Item Bank v1.0–Emotional Distress-Depression–Short Form 4a [
To assess confidence in managing medications and treatment, participants will complete the 4-item PROMIS Item Bank v1.0–Self-Efficacy for Managing Chronic Conditions–Managing Medications and Treatment–Short Form 4a [
Participants will complete the PROMIS Short Form v1.0–Sleep-Related Impairment 4a to evaluate overall sleep quality during the previous 7-day period [
Participants will complete the Short Healthy Eating Index (sHEI) survey, which is a 23-item survey that evaluates nutritional habits, such as fruit and vegetable consumption, water intake, and sugar consumption [
To measure medication adherence, participants will complete the Medication Adherence Rating Scale (MARS). The MARS is a general, 10-item binary questionnaire that asks questions related to regularly taking medication [
To measure the usability of the telehealth dashboard, participants will complete the System Usability Scale (SUS) and the Health Information Technology Usability Evaluation Scale (Health-ITUES). These Likert scales include items asking about the dashboard’s effectiveness (ability to complete tasks), efficiency (level of dashboard use), and satisfaction (subjective reactions to the dashboard) [
Participants will be asked to provide current medications and dosages throughout the study duration to control medication data during the statistical analysis.
This study will obtain measures related to the feasibility and acceptability of the My Health, My Life, My Way intervention on self-management for individuals with disabilities who also experience chronic conditions. Measures will include process, resource, scientific, and management feasibility outcomes. All elements of intervention delivery will be collected, including but not limited to adherence, retention, attrition, coach and participant communication needs, staff preparation, and adverse events. Obtaining these measures will inform future considerations in the delivery of a web-based self-management program for people with disabilities.
All data collected will be entered directly into REDCap and stored. Participants will be assigned a participant number upon enrollment in the study. Only approved study personnel will have access to the REDCap program, where data will be stored. Data checking will involve confirming that surveys, questionnaires, and health coaching calls are completed.
All statistical analyses will be conducted in an intent-to-treat manner at the individual level taking into account the correlated nature of data (multiple time points for every participant). Statistical significance will be evaluated at a type I error rate of 5%. Quality control will include descriptive and graphical approaches to summarize baseline characteristics of all key variables. With respect to data, we will begin by systematically cleaning and verifying all collected data, as well as examining ranges, missing values, and provenance. The significance tests conducted for the primary outcome are all specified a priori and modest in number. Consistent with published guidelines for statistical reporting, exact
Our 3-pronged approach involves minimizing missing data, leveraging the maximum likelihood–based approach or the multiple imputation approach under the assumptions of ignorability (ie, missing-at-random [MAR] assumption), and conducting multiple sensitivity analyses assuming MAR as well as missing not at random [
This project is a pilot feasibility and efficacy study that has a duration of 6 months and only involves minimal risks. Therefore, we believe that a data monitoring committee is not necessary. The principal investigator will be responsible for protocol fidelity and data collection throughout the study. The biostatistician will oversee data analysis in preparation for publication.
The My Health, My Life, My Way study will monitor all adverse events. Adverse events will be assessed for severity and causality and reported to the institutional review board and all other relevant regulatory bodies as needed.
All elements of the study protocol will be evaluated at regular intervals (ie, weekly, monthly, or quarterly) to ensure proper and consistent adherence to the study design and implementation. Elements of auditing will include checklists; coaching call logs; audio recordings or coaching calls; content resource banks; telehealth platform reviews and event logs; review of participant food, PA, and medication, as well as time spent on the platform and in regular team meetings to discuss participant progress; educational content provided during health coaching calls; and protocol adherence.
Any protocol changes deemed necessary by the principal investigator or study team will be submitted as amendments to the university’s institutional review board, and we will only apply changes after approval.
This protocol has been approved by the institutional review board of the University of Alabama at Birmingham (IRB-300009485).
All consent processes will be conducted on the web through predetermined screening questionnaires provided through the website landing page and REDCap link. If a participant is deemed eligible through the web-based process, an electronic consent form will be sent to the participant to complete. Only approved study staff will have access to completed records of the consent form.
Personal information will be collected in this study. All personal information shared, such as demographic details, will be collected and stored through REDCap. Only approved study staff will have access to securely stored personal information. All information will be subject to the university’s institutional review board and the policies of affiliated entities surrounding confidentiality.
The My Health, My Life, My Way protocol was funded in September 2020 and has been approved by the university’s institutional review board and registered at ClinicalTrials.gov (NCT05481593). The telehealth platform (dashboard and educational content) and website landing page are being developed by the study technical support team. Research personnel are developing the database (REDCap) that will store data and communication mechanisms (ie, emails and SMS text messaging notifications). We project that enrollment for the study will begin in May 2023, with data analysis being completed within 6 months of completing data collection.
The results of this study will be disseminated publicly through publication in peer-reviewed journals and presented at regional and national conferences.
The aim of this paper was to detail the study protocol used to develop a web-based self-management program for individuals with physical disabilities who also experience chronic conditions by using artificial intelligence techniques. The incorporation of variations in coaching calls and gamification will be evaluated to determine which combination of intervention components is the most effective for personal self-management. As the My Health, My Life, My Way program will be implementing a 4-arm protocol using the MOST design, many important implications can be drawn based on the findings of this study. The findings will assess what resources are required by self-management programs to maintain high levels of adherence and engagement. For coaching calls, if scheduled coaching calls are not as effective at promoting self-management as on-demand coaching calls, this would result in a reduced demand for excess resources, including the number of health coaches, monetary expenses, training, and daily availability of health coaches. If scheduled coaching calls are shown to be more effective than on-demand coaching calls, future web-based self-management programs should consider bolstering the resources to provide appropriate health coaching with qualified health coaches. Within the gamification context, the results from this study will inform future programming for individuals with physical disabilities who also experience chronic conditions. If gamified rewards are shown to be more effective than the fixed rewards model, self-management programs should consider using appropriate methods to promote extrinsic motivation by providing desirable incentives for behavior change. If fixed rewards are shown to be more effective than gamified rewards, this could indicate that a participant’s intrinsic motivation to improve their self-management is more important than extrinsic rewards such as redeeming increasing monetary incentives to promote behavior change.
As multiple barriers hinder a person’s ability to successfully manage chronic conditions, My Health, My Life, My Way aims to create a sustainable, scalable, accessible, implementable, sustainable, and inclusive self-management program for people with disabilities, which currently does not exist. This study will examine the feasibility and preliminary efficacy of My Health, My Life, My Way for individuals with physical disabilities who also experience chronic conditions using mobile apps and web-based applications, telehealth coaching sessions, and educational multimedia material. As part of the development process of My Health, My Life, My Way, we have conducted extensive focus groups with stakeholders with physical disabilities who also experience chronic conditions to obtain their perspectives on the proposed program and plan to implement relevant changes during further development. In addition, in line with the protocol, My Health, My Life, My Way is built upon a prior protocol evaluating the effectiveness of a web-based diabetes management program for individuals with physical disabilities [
This protocol includes limitations. First, we are using self-reported measures to collect data on participant perceptions about their physical and mental health. Therefore, we are relying on participants’ responses to be truthful when they answer all the surveys. The surveys we will use in this study have been shown to be reliable and valid in assessing physical and mental health outcomes. Second, My Health, My Life, My Way is using a web-based platform that participants will use to access multimedia content; therefore, those without internet capabilities will be unable to participate.
This study will add to the current literature to improve the quality of web-based self-management programs. In addition, not only will My Health, My Life, My Way determine how coaching calls and gamification variations affect behavior, but this program is also designed to be inclusive for those who experience physical disabilities, considered an underserved population. Finally, the findings from this study will inform how future self-management programs can be created and tailored to populations consisting of individuals with disabilities.
Peer-review report by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) - Disability and Rehabilitation Research Program (DRRP) (Washington, DC).
Akaike information criterion
Beliefs About Medication Questionnaire
Centers for Disease Control and Prevention
Health Information Technology Usability Evaluation Scale
Health Insurance Portability and Accountability Act
missing at random
Medication Adherence Rating Scale
multiphase optimization strategy
National Center on Health, Physical Activity and Disability
National Health and Nutrition Examination Survey
physical activity
Patient-Reported Outcomes Measurement Information System
Research Electronic Data Capture
36-item Short Form Health Survey, enabled version
Short Healthy Eating Index
Standard Protocol Items: Recommendations for Interventional Trials
System Usability Scale
This study was funded by the National Institute on Disability, Independent Living, and Rehabilitation Research (90DPGE0017).
The data generated or analyzed during the study will be available from the corresponding author on reasonable request.
EE, AZ, and MT contributed substantially to the conception and design of the work, drafted and revised the manuscript critically for important intellectual content, were responsible for the final approval of the version to be published, and agree to be accountable for all aspects of the work. AK, AW, TM, and AC were responsible for the design and analysis of the work, revised the work critically for important intellectual content and for final approval of the version to be published, and agree to be accountable for all aspects of the work.
TM has received consulting fees from The Obesity Society, PLOS One, and Novo Nordisk.