search
Back to results

Coordinating Pragmatic Primary Care Population Management for Obesity (C3PO)

Primary Purpose

Obesity, Cardiovascular Risk Factor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outreach Support for Weight Loss Goal Setting and Self-Weighing
Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions
Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring overweight, obesity, prediabetes, type 2 diabetes, hypertension, dyslipidemia, cardiovascular risk factor, adult, primary care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Basic Resources and Services

Coordinated Primary Care Population Management (C3PO)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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))

Secondary Outcome Measures

Costs to Implement the Intervention
Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components
Change in Hemoglobin A1C
Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
Change in Systolic Blood Pressure
Mean change in systolic blood pressure (mmHg) from baseline to 12 months
Change in Total Cholesterol
Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months
Change in Non-HDL Cholesterol
Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months
Body Mass Change at 6 Months
Mean Change in Body Mass (kg) from Baseline to 6 Months
Body Mass Change at 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
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))

Full Information

First Posted
June 21, 2019
Last Updated
January 28, 2022
Sponsor
Northwestern University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT03998046
Brief Title
Coordinating Pragmatic Primary Care Population Management for Obesity
Acronym
C3PO
Official Title
Coordinating Pragmatic Primary Care Population Management for Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Cardiovascular Risk Factor
Keywords
overweight, obesity, prediabetes, type 2 diabetes, hypertension, dyslipidemia, cardiovascular risk factor, adult, primary care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basic Resources and Services
Arm Type
Active Comparator
Arm Description
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
Arm Title
Coordinated Primary Care Population Management (C3PO)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Outreach Support for Weight Loss Goal Setting and Self-Weighing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support
Intervention Description
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
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
Title
Change in Hemoglobin A1C
Description
Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
Time Frame
Baseline - 12 Months
Title
Change in Systolic Blood Pressure
Description
Mean change in systolic blood pressure (mmHg) from baseline to 12 months
Time Frame
Baseline - 12 Months
Title
Change in Total Cholesterol
Description
Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months
Time Frame
Baseline - 12 Months
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
Title
Body Mass Change at 6 Months
Description
Mean Change in Body Mass (kg) from Baseline to 6 Months
Time Frame
Baseline - 6 Months
Title
Body Mass Change at 12 Months
Description
Mean Change in Body Mass (kg) from Baseline to 12 Months
Time Frame
Baseline - 12 Months
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Coordinating Pragmatic Primary Care Population Management for Obesity

We'll reach out to this number within 24 hrs