Trial Outcomes & Findings for EHR Embedded Comparative Effectiveness Studies--WWC (NCT NCT04514679)
NCT ID: NCT04514679
Last Updated: 2025-06-12
Results Overview
Percentage of those in each arm who complete the two visits in the correct order assigned.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline through approximately 2 months
Results posted on
2025-06-12
Participant Flow
Participant milestones
| Measure |
Dietician / Health Coach
Patients having obesity treatment would first see a dietician, and then see a health coach.
Dietician / Health Coach: The order of visit for the two types of providers is first Dietician then Health Coach.
|
Health Coach / Dietician
Patients having obesity treatment would first see a health coach, and then see a dietician.
Health Coach / Dietician: The order of visit for the two types of providers is first Health Coach then Dietician.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EHR Embedded Comparative Effectiveness Studies--WWC
Baseline characteristics by cohort
| Measure |
Dietician / Health Coach
n=28 Participants
Patients having obesity treatment would first see a dietician, and then see a health coach.
Dietician / Health Coach: The order of visit for the two types of providers is first Dietician then Health Coach.
|
Health Coach / Dietician
n=29 Participants
Patients having obesity treatment would first see a health coach, and then see a dietician.
Health Coach / Dietician: The order of visit for the two types of providers is first Health Coach then Dietician.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 14.4 • n=99 Participants
|
45.2 years
STANDARD_DEVIATION 13.5 • n=107 Participants
|
45.1 years
STANDARD_DEVIATION 13.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
29 participants
n=107 Participants
|
57 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline through approximately 2 monthsPopulation: Those who had health record data, which eliminated 3 patients.
Percentage of those in each arm who complete the two visits in the correct order assigned.
Outcome measures
| Measure |
Dietician / Health Coach
n=28 Participants
Patients having obesity treatment would first see a dietician, and then see a health coach.
Dietician / Health Coach: The order of visit for the two types of providers is first Dietician then Health Coach.
|
Health Coach / Dietician
n=29 Participants
Patients having obesity treatment would first see a health coach, and then see a dietician.
Health Coach / Dietician: The order of visit for the two types of providers is first Health Coach then Dietician.
|
|---|---|---|
|
Compliance Rate
|
87 percentage of participants
Interval 66.0 to 97.0
|
76 percentage of participants
Interval 54.0 to 90.0
|
PRIMARY outcome
Timeframe: One day, during the recruitment period of October 23, 2020 to February 3, 2021.Population: All patients who were identified as being eligible.
Percentage of those identified as being eligible who were enrolled in the study.
Outcome measures
| Measure |
Dietician / Health Coach
n=459 Participants
Patients having obesity treatment would first see a dietician, and then see a health coach.
Dietician / Health Coach: The order of visit for the two types of providers is first Dietician then Health Coach.
|
Health Coach / Dietician
Patients having obesity treatment would first see a health coach, and then see a dietician.
Health Coach / Dietician: The order of visit for the two types of providers is first Health Coach then Dietician.
|
|---|---|---|
|
Percentage of Eligible Patients Participating
|
13.1 percentage of eligible patients
Interval 10.2 to 16.6
|
—
|
SECONDARY outcome
Timeframe: 30 days since baselinePopulation: Those who had health record data, which eliminated 3 patients.
Linear trends (or "slopes") for per 30 days are calculated in each group. The slopes were calculated from repeated BMI measurements in each treatment group, and expressed in terms of the change in BMI predicted at 30 days post randomization.
Outcome measures
| Measure |
Dietician / Health Coach
n=28 Participants
Patients having obesity treatment would first see a dietician, and then see a health coach.
Dietician / Health Coach: The order of visit for the two types of providers is first Dietician then Health Coach.
|
Health Coach / Dietician
n=29 Participants
Patients having obesity treatment would first see a health coach, and then see a dietician.
Health Coach / Dietician: The order of visit for the two types of providers is first Health Coach then Dietician.
|
|---|---|---|
|
Change in Body Mass Index (BMI) at 30 Days
|
-0.07 kg/m^2
Standard Error 0.25
|
-0.16 kg/m^2
Standard Error 0.20
|
Adverse Events
Dietician / Health Coach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Coach / Dietician
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
Tor D. Tosteson, ScD
Dartmouth Geisel School of Medicine
Phone: 603 646-5274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place