Health Coaching & Technology in a Weight Loss Center

Study Overview
=================
Brief Summary
-----------------
The national epidemic of obesity is associated with considerable morbidity, disability and early mortality. Conventional weight loss programs beyond a primary care setting have the potential to reduce weight, but are difficult to access for adults with obesity in rural areas due to lack of transportation and access to specialty care. Routine intensive behavioral therapy, while effective, is often not supplemented with adjuncts that could be helpful in engaging participants in behavioral change. The overarching goal of this SYNERGY pilot project is to overcome barriers rural adults face by using video-conferencing to deliver specialty obesity care that otherwise is inaccessible to most adults faced with this disease. It also intends to use emerging mobile health (mHealth) technology which has shown considerable promise in providing motivational feedback. This proposal highlights T3/T4 translation bridging technologists, allied health staff, and clinicians in the development and implementation of new therapeutic modalities. The study aims to evaluate a telehealth-based health coaching program that is embedded in the Dartmouth-Hitchcock Weight and Wellness Center that integrates novel remote monitoring technology in effecting behavioral change using Amulet, a Dartmouth Computer Science developed mHealth device over a 16-week period. First, the feasibility and accessibility of an eHealth-delivered health coaching obesity intervention using remote monitoring and video-conferencing (Aim 1) will be evaluated. The potential effectiveness of achieving the primary outcome of 5% weight loss, with secondary outcomes of improved physical function and self reported health (Aim 2) will be ascertained. The intervention's impact on implementation outcomes of workflow, adoption, and organizational change that could affect further scalability and generalizability in other high-risk population groups (Aim 3) will be assessed. These preliminary findings will be used in a future competitive application for an extramural R01 designed to assess the effectiveness of our intervention in achieving weight loss in rural obese adults. If successful, this application has the potential to redesign care using applied methods of telehealth translated to community-based, rural populations to facilitate behavioral change. The project also meets criteria of the NIH Strategic Plan for Obesity and the Institute of Medicine's need for Telehealth research.

Official Title
-----------------
A Pilot Study of an eHealth-delivered Health Coaching Intervention

Conditions
-----------------
Obesity, Technology, Videoconferencing, mHealth, Behavior, Health

Intervention / Treatment
-----------------
* Behavioral: eHealth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking; Community-dwelling; Age 18-65 years; Obesity based on: BMI ≥30kg/m2 54; Participating in the DH-WWC health coach program; Access to home, high-speed internet with Wi-Fi; Medical clearance from their primary care provider; Provide voluntary, written consent; Require an EHR patient portal account and credentials ; -----If subjects do not have an account, one will be created for the purposes of this study Exclusion Criteria: Unwilling to participate in the 16 week pilot or complete study measures; Individuals unwilling/unable to provide consent; A medical record diagnosis of dementia as intensive behavioral therapy and health coaching require the ability to complete questionnaires and change behavior, all of which may be challenging in individuals with cognitive impairment; Cognitive impairment measured by the 6-item Callahan screen, a brief and reliable six-item screening questionnaire with acceptable sensitivity (88.7%) and specificity (88.0%) in identifying individuals with cognitive impairment. Its diagnostic properties are comparable to the full Folstein Mini-Mental Status Examination in those scoring ≥3. This questionnaire can be administered by telephone or face-to-face interview and is being as an adjunct to medical record documentation of cognitive impairment; Life-threatening illness including those receiving palliative care or hospice services; Nursing facility or hospital admission in the past six months; Psychiatric diagnosis that would interfere with study participation and require significant modification to meet their needs such as major depressive disorder, substance abuse, suicidal ideation or severe mental illness (schizophrenia, bipolar disorder); History of bariatric surgery; American College of Sports Medicine contraindications to exercise57 including: a resting heart rate of >120bpm; Blood pressure >180/100mmHg; unstable angina;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Amulet only<br>As per usual care participants will receive an eHealth (Amulet + videoconferencing) intervention over a 16 week period of time. | Behavioral: eHealth<br>* Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring<br>|
| Amulet/Fitbit<br>As per usual care participants will receive an eHealth (Amulet/Fitbit + videoconferencing) intervention over a 16 week period of time. | Behavioral: eHealth<br>* Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring<br>|
| Fitbit only<br>As per usual care participants will receive an eHealth (Fitbit + videoconferencing) intervention over a 16 week period of time. | Behavioral: eHealth<br>* Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion Rate: Number of Participants Completing the Intervention | Completion/ Feasibility: The following rates will be computed: screened for inclusion; eligibility; enrollment; completion; assessment. We will assess entry criteria (reasons for dropout/non-adherence) and time to collect data. Enrollment success will be defined as 30 patients. Adequate retention is defined as a dropout rate of <20%. Completion of >80% of post-study measures will be defined as adequate. Attending >80% of sessions will be considered acceptable. Staff will track equipment, software or technical issues (malfunctions, data loss, hardware) in a journal. | 16 weeks | 
| Acceptability | Acceptability: Qualitative interviews will ensure the appropriateness of the pilot and its strengths/weaknesses. Participants will answer questions on a scale from 0-5, where 5 = high acceptability of the program. | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Weight will be measured using a Seca 770 analyzer (in clinic) and by the Omron HBF-514 (at home remotely). Weight Loss (change in weight) | Baseline/16 weeks | 
| Change in 6 Minute Walk | 6-Minute Walk (6MWT) is a cardiovascular fitness surrogate measuring distance (normal 400-700m) related to function. A clinically important difference or change is 50-55m | Baseline/16 weeks - pre/post change - increase = longer distance | 
| Diet Change | The Rapid Eating Assessment for Participants (REAPS) is a 16 item survey (score 13-39) of diet habits. Higher scores = higher diet quality. Positive score = better diet quality | Baseline/16 weeks | 
| Subjective Health | The 10-question, non-proprietary Patient Reported Outcomes Measurement Information Systems General Health-10 (PROMIS) captures physical, mental and social aspects of quality of life. Positive change scores = improved health. The score ranges from 0-100, 50 is the population mean, 10 consists of 1SD, and higher scores equate better health. | Baseline/16 weeks - Change | 
| Readiness to Change | The University of Rhode Island Change Assessment is a 12 item questionnaire assessing one's stages of change based on contemplation, action, maintenance and pre-contemplation.. The range of scores from -2 to +14. Higher scores indicate higher readiness to change | 16 weeks | 
| Willingness to Pay | Patient Perception of Value: Two questions will assess Willingness to Pay (WTP) - whether they would pay for telemedicine delivery of the intervention in lieu of in-person travel time or cost. | 16 weeks |