Coordinating Pragmatic Primary Care Population Management for Obesity

Obesity Clinical Trial

— C3PO  

Official title:

Coordinating Pragmatic Primary Care Population Management for Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998046
• Other study ID #: STU00207153
• Secondary ID: R34DK114773
• Status: Completed
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: January 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Obesity

Intervention

Behavioral:
• Outreach 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.
• Outreach 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.
• Adaptive 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

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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