Trial Outcomes & Findings for Coordinating Pragmatic Primary Care Population Management for Obesity (NCT NCT03998046)
NCT ID: NCT03998046
Last Updated: 2022-02-22
Results Overview
Proportion of Participants who Reach a 5% Weight Loss Goal at 6 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 6 months (kg))/(Baseline body mass (kg))
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline - 6 Months
Results posted on
2022-02-22
Participant Flow
Participant milestones
| Measure |
Basic Resources and Services
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community
|
Coordinated Primary Care Population Management (C3PO)
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
42
|
|
Overall Study
COMPLETED
|
38
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical A1c values were not available for all participants
Baseline characteristics by cohort
| Measure |
Basic Resources and Services
n=38 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
|
Coordinated Primary Care Population Management (C3PO)
n=42 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-44 years
|
8 Participants
n=38 Participants
|
4 Participants
n=42 Participants
|
12 Participants
n=80 Participants
|
|
Age, Customized
45-64 years
|
18 Participants
n=38 Participants
|
26 Participants
n=42 Participants
|
44 Participants
n=80 Participants
|
|
Age, Customized
65+ years
|
12 Participants
n=38 Participants
|
12 Participants
n=42 Participants
|
24 Participants
n=80 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=38 Participants
|
24 Participants
n=42 Participants
|
50 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=38 Participants
|
18 Participants
n=42 Participants
|
30 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=38 Participants
|
8 Participants
n=42 Participants
|
11 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 Participants
n=38 Participants
|
11 Participants
n=42 Participants
|
23 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=38 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=38 Participants
|
18 Participants
n=42 Participants
|
34 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=38 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=80 Participants
|
|
Pre-diabetes
|
19 Participants
n=38 Participants
|
11 Participants
n=42 Participants
|
30 Participants
n=80 Participants
|
|
Diabetes
|
6 Participants
n=38 Participants
|
13 Participants
n=42 Participants
|
19 Participants
n=80 Participants
|
|
High blood pressure
|
29 Participants
n=38 Participants
|
33 Participants
n=42 Participants
|
62 Participants
n=80 Participants
|
|
Hyperlipidemia
|
27 Participants
n=38 Participants
|
34 Participants
n=42 Participants
|
61 Participants
n=80 Participants
|
|
Baseline clinical weight
|
209.2 lbs.
STANDARD_DEVIATION 40.5 • n=38 Participants
|
205.9 lbs.
STANDARD_DEVIATION 35.6 • n=42 Participants
|
207.5 lbs.
STANDARD_DEVIATION 37.8 • n=80 Participants
|
|
Hemoglobin A1C
|
6.03 Percent of HbA1C
STANDARD_DEVIATION 0.90 • n=33 Participants • Clinical A1c values were not available for all participants
|
6.29 Percent of HbA1C
STANDARD_DEVIATION 1.35 • n=34 Participants • Clinical A1c values were not available for all participants
|
6.16 Percent of HbA1C
STANDARD_DEVIATION 1.15 • n=67 Participants • Clinical A1c values were not available for all participants
|
|
Systolic Blood Pressure
|
136.89 mmHg
STANDARD_DEVIATION 18.25 • n=38 Participants
|
132.83 mmHg
STANDARD_DEVIATION 17.72 • n=42 Participants
|
134.76 mmHg
STANDARD_DEVIATION 17.98 • n=80 Participants
|
|
Total Cholesterol
|
183.22 mg/dL
STANDARD_DEVIATION 41.04 • n=37 Participants • Clinical total cholesterol values were not available for all participants.
|
187.27 mg/dL
STANDARD_DEVIATION 49.21 • n=41 Participants • Clinical total cholesterol values were not available for all participants.
|
185.35 mg/dL
STANDARD_DEVIATION 45.27 • n=78 Participants • Clinical total cholesterol values were not available for all participants.
|
|
Non-HDL Cholesterol
|
127.08 mg/dL
STANDARD_DEVIATION 35.23 • n=37 Participants • Clinical Non-HDL Cholesterol values not available for all participants.
|
133.46 mg/dL
STANDARD_DEVIATION 45.56 • n=41 Participants • Clinical Non-HDL Cholesterol values not available for all participants.
|
130.44 mg/dL
STANDARD_DEVIATION 40.85 • n=78 Participants • Clinical Non-HDL Cholesterol values not available for all participants.
|
PRIMARY outcome
Timeframe: Baseline - 6 MonthsProportion of Participants who Reach a 5% Weight Loss Goal at 6 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 6 months (kg))/(Baseline body mass (kg))
Outcome measures
| Measure |
Basic Resources and Services
n=38 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
|
Coordinated Primary Care Population Management (C3PO)
n=42 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
|---|---|---|
|
Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline - 12 MonthsPopulation: Intervention cost inputs include personnel, supplies, contract services, and facility and administrative costs, all from the perspective of the health system. Research-only costs were excluded from intervention cost estimations.
Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components
Outcome measures
| Measure |
Basic Resources and Services
n=38 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
|
Coordinated Primary Care Population Management (C3PO)
n=42 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
|---|---|---|
|
Costs to Implement the Intervention
|
423 US Dollars per enrolled participant
|
572 US Dollars per enrolled participant
|
SECONDARY outcome
Timeframe: Baseline - 12 MonthsMean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
Outcome measures
| Measure |
Basic Resources and Services
n=33 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
|
Coordinated Primary Care Population Management (C3PO)
n=34 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
|---|---|---|
|
Change in Hemoglobin A1C
|
-.11 Percent of HbA1C
Standard Deviation .42
|
.09 Percent of HbA1C
Standard Deviation .80
|
SECONDARY outcome
Timeframe: Baseline - 12 MonthsMean change in systolic blood pressure (mmHg) from baseline to 12 months
Outcome measures
| Measure |
Basic Resources and Services
n=38 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
|
Coordinated Primary Care Population Management (C3PO)
n=42 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-3.34 mmHg
Standard Deviation 18.09
|
.45 mmHg
Standard Deviation 20.06
|
SECONDARY outcome
Timeframe: Baseline - 12 MonthsMean change in total cholesterol concentration (mg/dL) from baseline to 12 months
Outcome measures
| Measure |
Basic Resources and Services
n=37 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
|
Coordinated Primary Care Population Management (C3PO)
n=41 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
|---|---|---|
|
Change in Total Cholesterol
|
4.22 mg/dL
Standard Deviation 12.18
|
-8.59 mg/dL
Standard Deviation 31.95
|
SECONDARY outcome
Timeframe: Baseline - 12 MonthsMean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months
Outcome measures
| Measure |
Basic Resources and Services
n=37 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
|
Coordinated Primary Care Population Management (C3PO)
n=41 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
|---|---|---|
|
Change in Non-HDL Cholesterol
|
4.14 mg/dL
Standard Deviation 13.80
|
-9.54 mg/dL
Standard Deviation 29.92
|
SECONDARY outcome
Timeframe: Baseline - 6 MonthsMean Change in Body Mass (kg) from Baseline to 6 Months
Outcome measures
| Measure |
Basic Resources and Services
n=36 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
|
Coordinated Primary Care Population Management (C3PO)
n=41 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
|---|---|---|
|
Body Mass Change at 6 Months
|
-4.19 kg
Standard Deviation 7.89
|
-1.22 kg
Standard Deviation 9.15
|
SECONDARY outcome
Timeframe: Baseline - 12 MonthsMean Change in Body Mass (kg) from Baseline to 12 Months
Outcome measures
| Measure |
Basic Resources and Services
n=36 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
|
Coordinated Primary Care Population Management (C3PO)
n=41 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
|---|---|---|
|
Body Mass Change at 12 Months
|
-3.16 kg
Standard Deviation 11.66
|
-1.87 kg
Standard Deviation 10.99
|
SECONDARY outcome
Timeframe: Baseline - 12 MonthsProportion of Participants who Reach a 5% Weight Loss Goal at 12 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 12 months (kg))/(Baseline body mass (kg))
Outcome measures
| Measure |
Basic Resources and Services
n=38 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community.
|
Coordinated Primary Care Population Management (C3PO)
n=42 Participants
Patients received outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
|---|---|---|
|
Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months
|
7 Participants
|
10 Participants
|
Adverse Events
Basic Resources and Services
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Coordinated Primary Care Population Management (C3PO)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place