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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
80
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.
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.
Northwestern Medicine
Chicago, Illinois, United States
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
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
Change in Hemoglobin A1C
Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
Time frame: Baseline - 12 Months
Change in Systolic Blood Pressure
Mean change in systolic blood pressure (mmHg) from baseline to 12 months
Time frame: Baseline - 12 Months
Change in Total Cholesterol
Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months
Time frame: Baseline - 12 Months
Change in Non-HDL Cholesterol
Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months
Time frame: Baseline - 12 Months
Body Mass Change at 6 Months
Mean Change in Body Mass (kg) from Baseline to 6 Months
Time frame: Baseline - 6 Months
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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
Body Mass Change at 12 Months
Mean Change in Body Mass (kg) from Baseline to 12 Months
Time frame: Baseline - 12 Months
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