Trial Outcomes & Findings for Health Coaching & Technology in a Weight Loss Center (NCT NCT03309787)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

37 participants

Primary outcome timeframe

16 weeks

Results posted on

2020-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Combined Group (Amulet/Fitbit) Combined group (Amulet/Fitbit) - Groups were combined because there was not enough data to analyze them separately	Fitbit Only Fitbit only as a remote monitoring device (in lieu of Amulet)	Amulet Only Amulet only device for remote monitoring
Overall Study STARTED	8	20	9
Overall Study COMPLETED	6	14	7
Overall Study NOT COMPLETED	2	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Health Coaching & Technology in a Weight Loss Center

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combined Amulet/Fitbit n=8 Participants 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	Amulet Only n=9 Participants 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	Fitbit Only n=20 Participants 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	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants	37 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	48.4 years STANDARD_DEVIATION 12.5 • n=5 Participants	49.4 years STANDARD_DEVIATION 10.3 • n=7 Participants	45.1 years STANDARD_DEVIATION 12.1 • n=5 Participants	46.9 years STANDARD_DEVIATION 11.6 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants	32 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants	37 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants	37 participants n=4 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Total completers

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.

Outcome measures

Outcome measures
Measure	Combined Amulet/Fitbit n=6 Participants 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	Fitbit Only n=14 Participants videoconferencing + fitbit	Amulet Only n=7 Participants videoconferencing + amulet as a remote monitoring device
Completion Rate: Number of Participants Completing the Intervention	6 Participants	14 Participants	7 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Population: On a scale of 0 (very disatisfied) to 5 (very satisfied) regarding the acceptability of the intervention

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.

Outcome measures

Outcome measures
Measure	Combined Amulet/Fitbit n=6 Participants 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	Fitbit Only n=7 Participants videoconferencing + fitbit	Amulet Only n=14 Participants videoconferencing + amulet as a remote monitoring device
Acceptability	4 score on a scale Interval 4.0 to 5.0	4 score on a scale Interval 3.0 to 5.0	5 score on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Combined Amulet/Fitbit n=6 Participants 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	Fitbit Only n=14 Participants videoconferencing + fitbit	Amulet Only n=7 Participants videoconferencing + amulet as a remote monitoring device
Change in Weight	-0.47 weight change (kg) Standard Deviation 2.77	-3.06 weight change (kg) Standard Deviation 3.63	-2.51 weight change (kg) Standard Deviation 2.16

SECONDARY outcome

Timeframe: Baseline/16 weeks - pre/post change - increase = longer distance

Population: 2 participants in combined amulet/fitbit group were unable to perform assessment

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

Outcome measures

Outcome measures
Measure	Combined Amulet/Fitbit n=4 Participants 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	Fitbit Only n=7 Participants videoconferencing + fitbit	Amulet Only n=14 Participants videoconferencing + amulet as a remote monitoring device
Change in 6 Minute Walk	111.25 meters Standard Deviation 27.8	227.14 meters Standard Deviation 140.14	-45.67 meters Standard Deviation 180.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Combined Amulet/Fitbit n=6 Participants 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	Fitbit Only n=14 Participants videoconferencing + fitbit	Amulet Only n=7 Participants videoconferencing + amulet as a remote monitoring device
Diet Change	3.17 units on a scale Standard Deviation 4.71	2.42 units on a scale Standard Deviation 4.11	2.85 units on a scale Standard Deviation 2.91

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Combined Amulet/Fitbit n=6 Participants 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	Fitbit Only n=14 Participants videoconferencing + fitbit	Amulet Only n=7 Participants videoconferencing + amulet as a remote monitoring device
Subjective Health	2.58 units on a scale Standard Deviation 6.11	4.54 units on a scale Standard Deviation 4.38	5.6 units on a scale Standard Deviation 6.8

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Combined Amulet/Fitbit n=6 Participants 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	Fitbit Only n=14 Participants videoconferencing + fitbit	Amulet Only n=7 Participants videoconferencing + amulet as a remote monitoring device
Readiness to Change	10.22 score on a scale Standard Deviation 1.31	9.64 score on a scale Standard Deviation 2.33	10.3 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Combined Amulet/Fitbit n=6 Participants 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	Fitbit Only n=7 Participants videoconferencing + fitbit	Amulet Only n=14 Participants videoconferencing + amulet as a remote monitoring device
Willingness to Pay Time · >60min	0 Participants	1 Participants	3 Participants
Willingness to Pay Time · <60min	6 Participants	6 Participants	11 Participants
Willingness to Pay Cost <$30 · >60min	5 Participants	7 Participants	11 Participants
Willingness to Pay Cost <$30 · <60min	1 Participants	0 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Combined Amulet/Fitbit n=8 Participants 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	Fitbit Only videoconferencing + fitbit	Amulet Only videoconferencing + amulet as a remote monitoring device
Staff Adoption	2.64 units on a scale Standard Deviation 0.49	—	—

Adverse Events

Combined Amulet/Fitbit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Amulet Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fitbit Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John A. Batsis, MD

Dartmouth-Hitchcock

Phone: 603-650-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place