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
Among 13 studies in Obesity by Dartmouth-Hitchcock Medical Center — none open to participants now, none under way, none of them phase 3. Obesity · Dartmouth-Hitchcock Medical Center.
Among the 13 studies in Obesity by Dartmouth-Hitchcock Medical Center, this one is one of 3 that started in 2017, is one of 3 observational ones, and was the 8th registered.
11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.
Browse Obesity studies →None of the 13 studies in Obesity by Dartmouth-Hitchcock Medical Center is open now. The open studies under Obesity, anywhere →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 3 started in 2017.
This study's enrollment of 37 is below the median of 115 across 2,157 observational studies indexed under Obesity.
Median enrollment 49 across the 10 interventional studies, 40 across the 3 observational. Of the 13 that completed or were terminated, 5 (38%) have results posted.
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Dartmouth-Hitchcock Medical Center is the lead sponsor of 488 studies on the registry; 70 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Obesity by Dartmouth-Hitchcock Medical Center, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Oct 2018, 10 months.
Results were first posted in Jul 2020, 1 year 9 months after primary completion.
Of 792 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's 10 months is below that.
Counting every sponsor, half of 837 studies reached it within 39 months; a quarter within 17 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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