An observational study in Obesity, Technology and Videoconferencing, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-08.
Sponsored by Dartmouth-Hitchcock Medical Center · Observational
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.
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
Exclusion Criteria:
As per usual care participants will receive an eHealth (Amulet + videoconferencing) intervention over a 16 week period of time.
Behavioral: eHealth
As per usual care participants will receive an eHealth (Amulet/Fitbit + videoconferencing) intervention over a 16 week period of time.
Behavioral: eHealth
As per usual care participants will receive an eHealth (Fitbit + videoconferencing) intervention over a 16 week period of time.
Behavioral: 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
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
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
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
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
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
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
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
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
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
| Milestone | Combined Group (Amulet/Fitbit) | Fitbit Only | Amulet Only |
|---|---|---|---|
| Started | 8 | 20 | 9 |
| Completed | 6 | 14 | 7 |
| Not completed | 2 | 6 | 2 |
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.
| Participants | Combined Amulet/Fitbit | Fitbit Only | Amulet Only |
|---|---|---|---|
| Completion Rate: Number of Participants Completing the Intervention | 6 | 14 | 7 |
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.
| score on a scale | Combined Amulet/Fitbit | Amulet Only | Fitbit Only |
|---|---|---|---|
| Acceptability | 4 (4 to 5) | 4 (3 to 5) | 5 (4 to 5) |
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)
| weight change (kg) | Combined Amulet/Fitbit | Fitbit Only | Amulet |
|---|---|---|---|
| Change in Weight | -0.47 ± 2.77 | -3.06 ± 3.63 | -2.51 ± 2.16 |
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
| meters | Combined Amulet/Fitbit | Amulet Only | Fitbit Only |
|---|---|---|---|
| Change in 6 Minute Walk | 111.25 ± 27.8 | 227.14 ± 140.14 | -45.67 ± 180.5 |
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
| units on a scale | Combined Amulet/Fitbit | Fitbit Only | Amulet |
|---|---|---|---|
| Diet Change | 3.17 ± 4.71 | 2.42 ± 4.11 | 2.85 ± 2.91 |
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.
| units on a scale | Combined Amulet/Fitbit | Fitbit Only | Amulet |
|---|---|---|---|
| Subjective Health | 2.58 ± 6.11 | 4.54 ± 4.38 | 5.6 ± 6.8 |
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
| score on a scale | Combined Amulet/Fitbit | Fitbit Only | Amulet |
|---|---|---|---|
| Readiness to Change | 10.22 ± 1.31 | 9.64 ± 2.33 | 10.3 ± 1.9 |
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.
| Participants | Combined Amulet/Fitbit | Amulet Only | Fitbit Only |
|---|---|---|---|
| Time — >60min | 0 | 1 | 3 |
| Time — <60min | 6 | 6 | 11 |
| Cost <$30 — >60min | 5 | 7 | 11 |
| Cost <$30 — <60min | 1 | 0 | 3 |
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).
| units on a scale | Staff Adoption |
|---|---|
| Staff Adoption | 2.64 ± 0.49 |
Collected over study itself - 16weeks;. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Combined Amulet/Fitbit | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Amulet Only | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Fitbit Only | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Combined Amulet/Fitbit | Amulet Only | Fitbit Only | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 9 | 20 | 37 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Combined Amulet/Fitbit | Amulet Only | Fitbit Only | Total |
|---|---|---|---|---|
| Mean | 48.4 ± 12.5 | 49.4 ± 10.3 | 45.1 ± 12.1 | 46.9 ± 11.6 |
| Sex: Female, Male(Participants) | Combined Amulet/Fitbit | Amulet Only | Fitbit Only | Total |
|---|---|---|---|---|
| Female | 8 | 8 | 16 | 32 |
| Male | 0 | 1 | 4 | 5 |
| Race (NIH/OMB)(Participants) | Combined Amulet/Fitbit | Amulet Only | Fitbit Only | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 8 | 9 | 20 | 37 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Combined Amulet/Fitbit | Amulet Only | Fitbit Only | Total |
|---|---|---|---|---|
| United States | 8 | 9 | 20 | 37 |
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Dartmouth-Hitchcock Medical Center