Coordinating Pragmatic Primary Care Population Management for Obesity

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor; Obesity
• Interventions: Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing; Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions; Behavioral: Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support

• Registration Number: NCT03998046
• Lead Sponsor: Northwestern University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Study Start: 2019-12-16
• Primary Completion: 2020-06-30
• Study Completion: 2021-06-30
• Results First Submitted: 2021-11-16
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-28
• Last Update Submitted: 2022-01-28
• Results First Posted: 2022-02-22
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Basic Resources and Services	Outreach Support for Weight Loss Goal Setting and Self-Weighing	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
Coordinated Primary Care Population Management (C3PO)	Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support	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.
Basic Resources and Services	Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions	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
Coordinated Primary Care Population Management (C3PO)	Outreach Support for Weight Loss Goal Setting and Self-Weighing	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.
Coordinated Primary Care Population Management (C3PO)	Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Body Mass Change at 12 Months	Baseline - 12 Months	Mean Change in Body Mass (kg) from Baseline to 12 Months
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 Total Cholesterol	Baseline - 12 Months	Mean change in total 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
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))
Change in Systolic Blood Pressure	Baseline - 12 Months	Mean change in systolic blood pressure (mmHg) 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

Trial Locations

Locations (1)

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States