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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amulet only | As per usual care participants will receive an eHealth (Amulet + videoconferencing) intervention over a 16 week period of time. |
| |
| Amulet/Fitbit | As per usual care participants will receive an eHealth (Amulet/Fitbit + videoconferencing) intervention over a 16 week period of time. |
| |
| Fitbit only | As per usual care participants will receive an eHealth (Fitbit + videoconferencing) intervention over a 16 week period of time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eHealth | Behavioral | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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This study will recruit 30 older motivated adults with obesity (aged 18-65 years). This study pilot will be based at the Dartmouth-Hitchcock (D-H) Weight and Wellness Center (DH-WWC) in Lebanon, NH. No randomization will be performed. Health coaches will deliver the intervention to participants
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| Name | Affiliation | Role |
|---|---|---|
| John A Batsis, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33015640 | Derived | Batsis JA, McClure AC, Weintraub AB, Sette D, Rotenberg S, Stevens CJ, Gilbert-Diamond D, Kotz DF, Bartels SJ, Cook SB, Rothstein RI. Barriers and facilitators in implementing a pilot, pragmatic, telemedicine-delivered healthy lifestyle program for obesity management in a rural, academic obesity clinic. Implement Sci Commun. 2020 Sep 30;1:83. doi: 10.1186/s43058-020-00075-9. eCollection 2020. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined Group (Amulet/Fitbit) | Combined group (Amulet/Fitbit) - Groups were combined because there was not enough data to analyze them separately |
| FG001 | Fitbit Only | Fitbit only as a remote monitoring device (in lieu of Amulet) |
| FG002 | Amulet Only | Amulet only device for remote monitoring |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Total completers | Posted | Count of Participants | Participants | 16 weeks |
|
study itself - 16weeks;
All subjects were asked about potential adverse events by the study interventionists at each study visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John A. Batsis, MD | Dartmouth-Hitchcock | 603-650-5000 | john.batsis@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2019 | Jul 1, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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|
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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Fitbit Only | videoconferencing + fitbit |
| OG002 | Amulet Only | videoconferencing + amulet as a remote monitoring device |
|
|
| 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. | On a scale of 0 (very disatisfied) to 5 (very satisfied) regarding the acceptability of the intervention | Posted | Median | Full Range | score on a scale | 16 Weeks |
|
|
|
| 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) | Posted | Mean | Standard Deviation | weight change (kg) | Baseline/16 weeks |
|
|
|
| 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 | 2 participants in combined amulet/fitbit group were unable to perform assessment | Posted | Mean | Standard Deviation | meters | Baseline/16 weeks - pre/post change - increase = longer distance |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline/16 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline/16 weeks - Change |
|
|
|
| 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 | higher score indicates higher readiness to change. The range of scores from -2 to +14. Higher scores indicate higher readiness to change | Posted | Mean | Standard Deviation | score on a scale | 16 weeks |
|
|
|
| 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. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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 | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Cost <$30 |
|