Coordinating Pragmatic Primary Care Population Management for Obesity (C3PO)

Northwestern University

Status: Completed

Conditions: Obesity; Cardiovascular Risk Factor

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03998046

R34DK114773 (U.S. NIH Grant/Contract)

STU00207153

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Basic Resources and Services

Active Comparator group

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

Treatment:

Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions

Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing

Coordinated Primary Care Population Management (C3PO)

Experimental group

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.

Treatment:

Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions

Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing

Behavioral: Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support