C3PO: Coordinating Pragmatic Primary Care Population Management for Obesity
Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT03998046
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
80
1
2
18.5
4.3
Study Details
Study Description
Brief Summary
The C3PO pilot and feasibility study uses a rigorous, mixed-method research design to provide information needed to refine and implement a technology-mediated primary care outreach intervention approach before conducting a larger and more definitive future intervention trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study will implement and evaluate a pragmatic and generalizable framework for population management of obesity by the primary care sector. With patient and other stakeholder input, the C3PO intervention will be designed to leverage existing primary care professionals and technologies to implement a scalable framework for population obesity management that coordinates primary care services with extant intensive lifestyle interventions in community settings to achieve wider reach and population-level effectiveness. A rigorous, mixed-method pilot and feasibility study will provide critical information needed to optimize the intervention design and prepare us for a larger and definitive future trial.
Study Design
Study Type:
Interventional
Actual Enrollment
:
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The active intervention "C3PO" involves enhanced use of pragmatic electronic health record system technologies and members of the primary care workforce to increase supportive accountability and problem solving support for weight loss goals and behavior, which in turn will lead to routine self-weighing, increased take up into intensive community programs, and increased adoption and maintenance of healthy eating and physical activity behaviors that collectively lead to greater weight loss at a population level.The active intervention "C3PO" involves enhanced use of pragmatic electronic health record system technologies and members of the primary care workforce to increase supportive accountability and problem solving support for weight loss goals and behavior, which in turn will lead to routine self-weighing, increased take up into intensive community programs, and increased adoption and maintenance of healthy eating and physical activity behaviors that collectively lead to greater weight loss at a population level.
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Patients will be randomized to either Basic Resources and Services or the C3PO intervention arm. Although patients will be aware of the specific forms of support they are receiving throughout the trial, each individual will not be aware that they are part of a randomized experiment and will not know that other patients may be receiving different levels of support. For this reason, the non-concealed nature of the behavioral support intervention for participating patients should not introduce bias. Investigators and outcome assessors will not be aware of intervention assignment during the study conduct or evaluation phase.
Primary Purpose:
Health Services Research
Official Title:
Coordinating Pragmatic Primary Care Population Management for Obesity
Actual Study Start Date
:
Dec 16, 2019
Actual Primary Completion Date
:
Jun 30, 2020
Actual Study Completion Date
:
Jun 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Basic Resources and Services Patients will receive 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 |
Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing
Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning. Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.
Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions
Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community. Patients who request information or clinical referrals will also receive them. "Refreshes" of community linkage information will be sent by MyChart every 1 to 4 weeks.
|
| Experimental: Coordinated Primary Care Population Management (C3PO) Patients will receive 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. |
Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing
Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning. Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.
Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions
Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community. Patients who request information or clinical referrals will also receive them. "Refreshes" of community linkage information will be sent by MyChart every 1 to 4 weeks.
Behavioral: Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support
Data received into the electronic health record from the cellular network-enabled electronic scale will categorize each patient based on their daily self-weighing behaviors and rate of progress towards their weight loss goal. Patients who are not engaged in daily self-weighing or are not making progress towards their goal will receive more intensive outreach support in the form of automated weekly MyChart problem solving messages, more frequent encouragement to access a broader array of community resources, and telephonic support from a nurse care coordinator who is an existing member of the primary care team. Support from this nurse care coordinator will be facilitated by the incorporation of each patient's self-weighing data into an EpicCare patient dashboard accessible to the nurse coordinator and other members of the care team
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months [Baseline - 6 Months]
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))
Secondary Outcome Measures
- Costs to Implement the Intervention [Baseline - 12 Months]
Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components
- Change in Hemoglobin A1C [Baseline - 12 Months]
Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
- Change in Systolic Blood Pressure [Baseline - 12 Months]
Mean change in systolic blood pressure (mmHg) from baseline to 12 months
- Change in Total Cholesterol [Baseline - 12 Months]
Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months
- Change in Non-HDL Cholesterol [Baseline - 12 Months]
Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months
- Body Mass Change at 6 Months [Baseline - 6 Months]
Mean Change in Body Mass (kg) from Baseline to 6 Months
- Body Mass Change at 12 Months [Baseline - 12 Months]
Mean Change in Body Mass (kg) from Baseline to 12 Months
- Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months [Baseline - 12 Months]
Proportion 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))
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
BMI ≥ 27 kg/m2
-
≥ 1 CVD risk condition (hypertension, dyslipidemia, prediabetes or type 2 diabetes)
-
Registered in Northwestern Medical Group's EpicCare MyChart patient portal
-
Received and completed MyChart survey of weight loss interest
-
Affirms interest in weight loss goal setting and receiving additional resource information and electronic Scale.
Exclusion Criteria:
-
Evidence of hospitalization in past 30 days
-
Most recent blood pressure >180/105
-
Cancer (non-skin) treatment within the past 2 years
-
Encounter diagnosis for hypoglycemia in past 30 days
-
Actively receiving care from the bariatric surgery service or a bariatric medication order in the past 100 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern Medicine | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Ronald Ackermann,
Professor of Medicine,
Northwestern University
ClinicalTrials.gov Identifier:
NCT03998046
Other Study ID Numbers:
- STU00207153
- R34DK114773
First Posted:
Jun 25, 2019
Last Update Posted:
Feb 22, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ronald Ackermann,
Professor of Medicine,
Northwestern University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Period Title: Overall Study | ||
| STARTED | 38 | 42 |
| COMPLETED | 38 | 42 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 of all reporting groups |
| Overall Participants | 38 | 42 | 80 |
| Age, Customized (Count of Participants) | |||
| 18-44 years |
8
21.1%
|
4
9.5%
|
12
15%
|
| 45-64 years |
18
47.4%
|
26
61.9%
|
44
55%
|
| 65+ years |
12
31.6%
|
12
28.6%
|
24
30%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
26
68.4%
|
24
57.1%
|
50
62.5%
|
| Male |
12
31.6%
|
18
42.9%
|
30
37.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Hispanic |
3
7.9%
|
8
19%
|
11
13.8%
|
| Black |
12
31.6%
|
11
26.2%
|
23
28.8%
|
| Asian |
2
5.3%
|
4
9.5%
|
6
7.5%
|
| White |
16
42.1%
|
18
42.9%
|
34
42.5%
|
| Other |
5
13.2%
|
1
2.4%
|
6
7.5%
|
| Pre-diabetes (Count of Participants) | |||
| Count of Participants [Participants] |
19
50%
|
11
26.2%
|
30
37.5%
|
| Diabetes (Count of Participants) | |||
| Count of Participants [Participants] |
6
15.8%
|
13
31%
|
19
23.8%
|
| High blood pressure (Count of Participants) | |||
| Count of Participants [Participants] |
29
76.3%
|
33
78.6%
|
62
77.5%
|
| Hyperlipidemia (Count of Participants) | |||
| Count of Participants [Participants] |
27
71.1%
|
34
81%
|
61
76.3%
|
| Baseline clinical weight (lbs.) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [lbs.] |
209.2
(40.5)
|
205.9
(35.6)
|
207.5
(37.8)
|
| Hemoglobin A1C (Percent of HbA1C) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Percent of HbA1C] |
6.03
(0.90)
|
6.29
(1.35)
|
6.16
(1.15)
|
| Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmHg] |
136.89
(18.25)
|
132.83
(17.72)
|
134.76
(17.98)
|
| Total Cholesterol (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
183.22
(41.04)
|
187.27
(49.21)
|
185.35
(45.27)
|
| Non-HDL Cholesterol (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
127.08
(35.23)
|
133.46
(45.56)
|
130.44
(40.85)
|
Outcome Measures
| Title | Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months |
|---|---|
| Description | 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)) |
| Time Frame | Baseline - 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 38 | 42 |
| Count of Participants [Participants] |
6
15.8%
|
6
14.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Basic Resources and Services, Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .85 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Costs to Implement the Intervention |
|---|---|
| Description | Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components |
| Time Frame | Baseline - 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 38 | 42 |
| Number [US Dollars per enrolled participant] |
423
|
572
|
| Title | Change in Hemoglobin A1C |
|---|---|
| Description | Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months |
| Time Frame | Baseline - 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 33 | 34 |
| Mean (Standard Deviation) [Percent of HbA1C] |
-.11
(.42)
|
.09
(.80)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Basic Resources and Services, Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .20 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change in Systolic Blood Pressure |
|---|---|
| Description | Mean change in systolic blood pressure (mmHg) from baseline to 12 months |
| Time Frame | Baseline - 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 38 | 42 |
| Mean (Standard Deviation) [mmHg] |
-3.34
(18.09)
|
.45
(20.06)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Basic Resources and Services, Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .38 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change in Total Cholesterol |
|---|---|
| Description | Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months |
| Time Frame | Baseline - 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 37 | 41 |
| Mean (Standard Deviation) [mg/dL] |
4.22
(12.18)
|
-8.59
(31.95)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Basic Resources and Services, Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .02 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change in Non-HDL Cholesterol |
|---|---|
| Description | Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months |
| Time Frame | Baseline - 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 37 | 41 |
| Mean (Standard Deviation) [mg/dL] |
4.14
(13.80)
|
-9.54
(29.92)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Basic Resources and Services, Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .01 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Body Mass Change at 6 Months |
|---|---|
| Description | Mean Change in Body Mass (kg) from Baseline to 6 Months |
| Time Frame | Baseline - 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 36 | 41 |
| Mean (Standard Deviation) [kg] |
-4.19
(7.89)
|
-1.22
(9.15)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Basic Resources and Services, Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .13 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Body Mass Change at 12 Months |
|---|---|
| Description | Mean Change in Body Mass (kg) from Baseline to 12 Months |
| Time Frame | Baseline - 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 36 | 41 |
| Mean (Standard Deviation) [kg] |
-3.16
(11.66)
|
-1.87
(10.99)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Basic Resources and Services, Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .61 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months |
|---|---|
| Description | Proportion 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)) |
| Time Frame | Baseline - 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 38 | 42 |
| Count of Participants [Participants] |
7
18.4%
|
10
23.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Basic Resources and Services, Coordinated Primary Care Population Management (C3PO) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .56 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Adverse Events
| Time Frame | Adverse event data were collected for 1 year following trial enrollment. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) | ||
| Arm/Group Description | 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. | 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. . | ||
All Cause Mortality |
||||
| Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/38 (0%) | 0/42 (0%) | ||
Serious Adverse Events |
||||
| Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/38 (0%) | 0/42 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/38 (0%) | 0/42 (0%) | ||
Limitations/Caveats
The COVID-19 pandemic began 6-10 weeks into the 12-week active intervention phase. The Illinois stay-at-home order interfered with access to intervention resources as fitness facilities were closed for several months. It also interfered with completion of healthcare visits where follow-up weight measures are captured. Outcome effects observed in this context may not be generalizable if replicated after the Coronavirus pandemic.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Ronald Ackermann, MD, MPH |
|---|---|
| Organization | Northwestern University |
| Phone | (312)-503-3232 |
| r.ackermann@northwestern.edu |
Responsible Party:
Ronald Ackermann,
Professor of Medicine,
Northwestern University
ClinicalTrials.gov Identifier:
NCT03998046
Other Study ID Numbers:
- STU00207153
- R34DK114773
First Posted:
Jun 25, 2019
Last Update Posted:
Feb 22, 2022
Last Verified:
Jan 1, 2022