Cardiovascular Risk Factor, Obesity
Conditions
Keywords
overweight, obesity, prediabetes, type 2 diabetes, hypertension, dyslipidemia, cardiovascular risk factor, adult, primary care
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.
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.
Interventions
BEHAVIORALOutreach 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.
BEHAVIORALOutreach 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.
BEHAVIORALAdaptive 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
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in Total Cholesterol | Baseline - 12 Months | Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months |
| 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 |
| 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)) |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| 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. | 42 |
| Total | 80 |
Baseline characteristics
| Characteristic | Basic Resources and Services | Coordinated Primary Care Population Management (C3PO) | Total |
|---|---|---|---|
| Age, Customized 18-44 years | 8 Participants | 4 Participants | 12 Participants |
| Age, Customized 45-64 years | 18 Participants | 26 Participants | 44 Participants |
| Age, Customized 65+ years | 12 Participants | 12 Participants | 24 Participants |
| Baseline clinical weight | 209.2 lbs. STANDARD_DEVIATION 40.5 | 205.9 lbs. STANDARD_DEVIATION 35.6 | 207.5 lbs. STANDARD_DEVIATION 37.8 |
| Diabetes | 6 Participants | 13 Participants | 19 Participants |
| Hemoglobin A1C | 6.03 Percent of HbA1C STANDARD_DEVIATION 0.9 | 6.29 Percent of HbA1C STANDARD_DEVIATION 1.35 | 6.16 Percent of HbA1C STANDARD_DEVIATION 1.15 |
| High blood pressure | 29 Participants | 33 Participants | 62 Participants |
| Hyperlipidemia | 27 Participants | 34 Participants | 61 Participants |
| Non-HDL Cholesterol | 127.08 mg/dL STANDARD_DEVIATION 35.23 | 133.46 mg/dL STANDARD_DEVIATION 45.56 | 130.44 mg/dL STANDARD_DEVIATION 40.85 |
| Pre-diabetes | 19 Participants | 11 Participants | 30 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Black | 12 Participants | 11 Participants | 23 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 8 Participants | 11 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Female | 26 Participants | 24 Participants | 50 Participants |
| Sex: Female, Male Male | 12 Participants | 18 Participants | 30 Participants |
| Systolic Blood Pressure | 136.89 mmHg STANDARD_DEVIATION 18.25 | 132.83 mmHg STANDARD_DEVIATION 17.72 | 134.76 mmHg STANDARD_DEVIATION 17.98 |
| Total Cholesterol | 183.22 mg/dL STANDARD_DEVIATION 41.04 | 187.27 mg/dL STANDARD_DEVIATION 49.21 | 185.35 mg/dL STANDARD_DEVIATION 45.27 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 42 |
| other Total, other adverse events | 0 / 38 | 0 / 42 |
| serious Total, serious adverse events | 0 / 38 | 0 / 42 |
Outcome results
Primary
Number of Participants Who Achieved 5% Weight Loss Goal at 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))
Time frame: Baseline - 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Resources and Services | Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months | 6 Participants |
| Coordinated Primary Care Population Management (C3PO) | Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months | 6 Participants |
p-value: 0.85Chi-squared
Secondary
Body Mass Change at 12 Months
Mean Change in Body Mass (kg) from Baseline to 12 Months
Time frame: Baseline - 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basic Resources and Services | Body Mass Change at 12 Months | -3.16 kg | Standard Deviation 11.66 |
| Coordinated Primary Care Population Management (C3PO) | Body Mass Change at 12 Months | -1.87 kg | Standard Deviation 10.99 |
p-value: 0.61t-test, 2 sided
Secondary
Body Mass Change at 6 Months
Mean Change in Body Mass (kg) from Baseline to 6 Months
Time frame: Baseline - 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basic Resources and Services | Body Mass Change at 6 Months | -4.19 kg | Standard Deviation 7.89 |
| Coordinated Primary Care Population Management (C3PO) | Body Mass Change at 6 Months | -1.22 kg | Standard Deviation 9.15 |
p-value: 0.13t-test, 2 sided
Secondary
Change in Hemoglobin A1C
Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
Time frame: Baseline - 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basic Resources and Services | Change in Hemoglobin A1C | -.11 Percent of HbA1C | Standard Deviation 0.42 |
| Coordinated Primary Care Population Management (C3PO) | Change in Hemoglobin A1C | .09 Percent of HbA1C | Standard Deviation 0.8 |
p-value: 0.2t-test, 2 sided
Secondary
Change in Non-HDL Cholesterol
Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months
Time frame: Baseline - 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basic Resources and Services | Change in Non-HDL Cholesterol | 4.14 mg/dL | Standard Deviation 13.8 |
| Coordinated Primary Care Population Management (C3PO) | Change in Non-HDL Cholesterol | -9.54 mg/dL | Standard Deviation 29.92 |
p-value: 0.01t-test, 2 sided
Secondary
Change in Systolic Blood Pressure
Mean change in systolic blood pressure (mmHg) from baseline to 12 months
Time frame: Baseline - 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basic Resources and Services | Change in Systolic Blood Pressure | -3.34 mmHg | Standard Deviation 18.09 |
| Coordinated Primary Care Population Management (C3PO) | Change in Systolic Blood Pressure | .45 mmHg | Standard Deviation 20.06 |
p-value: 0.38t-test, 2 sided
Secondary
Change in Total Cholesterol
Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months
Time frame: Baseline - 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basic Resources and Services | Change in Total Cholesterol | 4.22 mg/dL | Standard Deviation 12.18 |
| Coordinated Primary Care Population Management (C3PO) | Change in Total Cholesterol | -8.59 mg/dL | Standard Deviation 31.95 |
p-value: 0.02t-test, 2 sided
Secondary
Costs to Implement the Intervention
Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components
Time frame: Baseline - 12 Months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Basic Resources and Services | Costs to Implement the Intervention | 423 US Dollars per enrolled participant |
| Coordinated Primary Care Population Management (C3PO) | Costs to Implement the Intervention | 572 US Dollars per enrolled participant |
Secondary
Number of Participants Who Achieved 5% Weight Loss Goal in 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))
Time frame: Baseline - 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Resources and Services | Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months | 7 Participants |
| Coordinated Primary Care Population Management (C3PO) | Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months | 10 Participants |
p-value: 0.56Chi-squared