Obesity
Conditions
Brief summary
Randomize Everyone is a research project to develop new informatics systems and statistical methods for supporting randomization processes in EHR systems to do comparative effectiveness research. Two demonstration projects are being conducted in the Dartmouth Hitchcock Medical Center, designed to evaluate different weight loss interventions and common practices in the treatment of chronic low back pain.
Detailed description
EHR Embedded Comparative Effectiveness Studies-WWC will be held in the Weight and Wellness Clinics at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees to either the dietitian/health coach appointment sequence or the health coach/dietitian appointment sequence.
Interventions
BEHAVIORALDietician / Health Coach
The order of visit for the two types of providers is first Dietician then Health Coach.
BEHAVIORALHealth Coach / Dietician
The order of visit for the two types of providers is first Health Coach then Dietician.
Sponsors
Trustees of Dartmouth College
Patient-Centered Outcomes Research Institute
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Adults (\>18) able to consent, with sufficient fluency in English; Initial RD and HC visits are part of routine care as recommended by the provider; willing to be randomized
Exclusion criteria
Pregnant women; Prisoners; Children (\<18) \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance Rate | Baseline through approximately 2 months | Percentage of those in each arm who complete the two visits in the correct order assigned. |
| Percentage of Eligible Patients Participating | One day, during the recruitment period of October 23, 2020 to February 3, 2021. | Percentage of those identified as being eligible who were enrolled in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) at 30 Days | 30 days since baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 29 |
| Total | 57 |
Baseline characteristics
| Characteristic | Dietician / Health Coach | Total | Health Coach / Dietician |
|---|---|---|---|
| Age, Continuous | 45.0 years STANDARD_DEVIATION 14.4 | 45.1 years STANDARD_DEVIATION 13.8 | 45.2 years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 56 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 57 Participants | 29 Participants |
| Region of Enrollment United States | 28 participants | 57 participants | 29 participants |
| Sex: Female, Male Female | 23 Participants | 50 Participants | 27 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Compliance Rate
Percentage of those in each arm who complete the two visits in the correct order assigned.
Time frame: Baseline through approximately 2 months
Population: Those who had health record data, which eliminated 3 patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dietician / Health Coach | Compliance Rate | 87 percentage of participants |
| Health Coach / Dietician | Compliance Rate | 76 percentage of participants |
Primary
Percentage of Eligible Patients Participating
Percentage of those identified as being eligible who were enrolled in the study.
Time frame: One day, during the recruitment period of October 23, 2020 to February 3, 2021.
Population: All patients who were identified as being eligible.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dietician / Health Coach | Percentage of Eligible Patients Participating | 13.1 percentage of eligible patients |
Secondary
Change in Body Mass Index (BMI) at 30 Days
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.
Time frame: 30 days since baseline
Population: Those who had health record data, which eliminated 3 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietician / Health Coach | Change in Body Mass Index (BMI) at 30 Days | -0.07 kg/m^2 | Standard Error 0.25 |
| Health Coach / Dietician | Change in Body Mass Index (BMI) at 30 Days | -0.16 kg/m^2 | Standard Error 0.2 |