Behavior, Health, mHealth, Obesity, Technology, Videoconferencing
Conditions
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.
Interventions
BEHAVIORALeHealth
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
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 16 Weeks | 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. |
| Completion Rate: Number of Participants Completing the Intervention | 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 Minute Walk | Baseline/16 weeks - pre/post change - increase = longer distance | 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 |
| Diet Change | Baseline/16 weeks | 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 |
| Readiness to Change | 16 weeks | 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 |
| Willingness to Pay | 16 weeks | 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. |
| Subjective Health | Baseline/16 weeks - Change | 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. |
| Change in Weight | Baseline/16 weeks | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Staff Adoption | 16 weeks | Staff Adoption: Haug's 12-item Measure of Evidence-Based Practice Adoption assesses stage of change, experience, attitudes, organization barriers and strategies to support evidence-based practices (1-5 point scale - strongly disagree to agree). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combined Amulet/Fitbit As per usual care participants will receive an eHealth (Amulet/Fitbit + videoconferencing) intervention over a 16 week period of time.
eHealth: 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 | 8 |
| Amulet Only As per usual care participants will receive an eHealth (Amulet + videoconferencing) intervention over a 16 week period of time.
eHealth: 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 | 9 |
| Fitbit Only As per usual care participants will receive an eHealth (Fitbit + videoconferencing) intervention over a 16 week period of time.
eHealth: 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 | 20 |
| Total | 37 |
Baseline characteristics
| Characteristic | Amulet Only | Fitbit Only | Total | Combined Amulet/Fitbit |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 20 Participants | 37 Participants | 8 Participants |
| Age, Continuous | 49.4 years STANDARD_DEVIATION 10.3 | 45.1 years STANDARD_DEVIATION 12.1 | 46.9 years STANDARD_DEVIATION 11.6 | 48.4 years STANDARD_DEVIATION 12.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 20 Participants | 37 Participants | 8 Participants |
| Region of Enrollment United States | 9 participants | 20 participants | 37 participants | 8 participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 32 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 5 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 | 0 / 20 |
| other Total, other adverse events | 0 / 8 | 0 / 9 | 0 / 20 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 | 0 / 20 |
Outcome results
Primary
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.
Time frame: 16 Weeks
Population: On a scale of 0 (very disatisfied) to 5 (very satisfied) regarding the acceptability of the intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combined Amulet/Fitbit | Acceptability | 4 score on a scale |
| Fitbit Only | Acceptability | 4 score on a scale |
| Amulet Only | Acceptability | 5 score on a scale |
Primary
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.
Time frame: 16 weeks
Population: Total completers
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Amulet/Fitbit | Completion Rate: Number of Participants Completing the Intervention | 6 Participants |
| Fitbit Only | Completion Rate: Number of Participants Completing the Intervention | 14 Participants |
| Amulet Only | Completion Rate: Number of Participants Completing the Intervention | 7 Participants |
Secondary
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
Time frame: Baseline/16 weeks - pre/post change - increase = longer distance
Population: 2 participants in combined amulet/fitbit group were unable to perform assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Amulet/Fitbit | Change in 6 Minute Walk | 111.25 meters | Standard Deviation 27.8 |
| Fitbit Only | Change in 6 Minute Walk | 227.14 meters | Standard Deviation 140.14 |
| Amulet Only | Change in 6 Minute Walk | -45.67 meters | Standard Deviation 180.5 |
Secondary
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)
Time frame: Baseline/16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Amulet/Fitbit | Change in Weight | -0.47 weight change (kg) | Standard Deviation 2.77 |
| Fitbit Only | Change in Weight | -3.06 weight change (kg) | Standard Deviation 3.63 |
| Amulet Only | Change in Weight | -2.51 weight change (kg) | Standard Deviation 2.16 |
Secondary
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
Time frame: Baseline/16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Amulet/Fitbit | Diet Change | 3.17 units on a scale | Standard Deviation 4.71 |
| Fitbit Only | Diet Change | 2.42 units on a scale | Standard Deviation 4.11 |
| Amulet Only | Diet Change | 2.85 units on a scale | Standard Deviation 2.91 |
Secondary
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
Time frame: 16 weeks
Population: higher score indicates higher readiness to change. The range of scores from -2 to +14. Higher scores indicate higher readiness to change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Amulet/Fitbit | Readiness to Change | 10.22 score on a scale | Standard Deviation 1.31 |
| Fitbit Only | Readiness to Change | 9.64 score on a scale | Standard Deviation 2.33 |
| Amulet Only | Readiness to Change | 10.3 score on a scale | Standard Deviation 1.9 |
Secondary
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.
Time frame: Baseline/16 weeks - Change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Amulet/Fitbit | Subjective Health | 2.58 units on a scale | Standard Deviation 6.11 |
| Fitbit Only | Subjective Health | 4.54 units on a scale | Standard Deviation 4.38 |
| Amulet Only | Subjective Health | 5.6 units on a scale | Standard Deviation 6.8 |
Secondary
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.
Time frame: 16 weeks
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Combined Amulet/Fitbit | Willingness to Pay | Cost <$30 | >60min | 5 Participants |
| Combined Amulet/Fitbit | Willingness to Pay | Time | <60min | 6 Participants |
| Combined Amulet/Fitbit | Willingness to Pay | Time | >60min | 0 Participants |
| Combined Amulet/Fitbit | Willingness to Pay | Cost <$30 | <60min | 1 Participants |
| Fitbit Only | Willingness to Pay | Time | <60min | 6 Participants |
| Fitbit Only | Willingness to Pay | Time | >60min | 1 Participants |
| Fitbit Only | Willingness to Pay | Cost <$30 | <60min | 0 Participants |
| Fitbit Only | Willingness to Pay | Cost <$30 | >60min | 7 Participants |
| Amulet Only | Willingness to Pay | Time | >60min | 3 Participants |
| Amulet Only | Willingness to Pay | Cost <$30 | <60min | 3 Participants |
| Amulet Only | Willingness to Pay | Cost <$30 | >60min | 11 Participants |
| Amulet Only | Willingness to Pay | Time | <60min | 11 Participants |
Other Pre-specified
Staff Adoption
Staff Adoption: Haug's 12-item Measure of Evidence-Based Practice Adoption assesses stage of change, experience, attitudes, organization barriers and strategies to support evidence-based practices (1-5 point scale - strongly disagree to agree).
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Amulet/Fitbit | Staff Adoption | 2.64 units on a scale | Standard Deviation 0.49 |