Coordinating Pragmatic Primary Care Population Management for Obesity

NCT03998046 | Completed Results

• 2 other identifiers: STU00207153R34DK114773
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Cardiovascular Risk Factor

Keywords

overweight; obesity; prediabetes; type 2 diabetes; hypertension; dyslipidemia; cardiovascular risk factor; adult; primary care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Costs to Implement the Intervention

  Baseline - 12 Months

• Change in Hemoglobin A1C

  Baseline - 12 Months

• Change in Systolic Blood Pressure

  Baseline - 12 Months

• Change in Total Cholesterol

  Baseline - 12 Months

• Change in Non-HDL Cholesterol

  Baseline - 12 Months

Study Arms (2)

Basic Resources and Services

ACTIVE COMPARATOR

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

Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing; Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions

Coordinated Primary Care Population Management (C3PO)

EXPERIMENTAL

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.

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

Interventions

Outreach Support for Weight Loss Goal Setting and Self-Weighing BEHAVIORAL

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.

Basic Resources and Services; Coordinated Primary Care Population Management (C3PO)

Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions BEHAVIORAL

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.

Basic Resources and Services; Coordinated Primary Care Population Management (C3PO)

Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support BEHAVIORAL

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

Coordinated Primary Care Population Management (C3PO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Prediabetic State; Diabetes Mellitus, Type 2; Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders

Limitations and Caveats

The COVID-19 pandemic began 6-10 weeks into the 12-week active intervention phase. The Illinois stay-at-home order interfered with access to intervention resources as fitness facilities were closed for several months. It also interfered with completion of healthcare visits where follow-up weight measures are captured. Outcome effects observed in this context may not be generalizable if replicated after the Coronavirus pandemic.

Results Point of Contact

• Title: Ronald Ackermann, MD, MPH
• Organization: Northwestern University

r.ackermann@northwestern.edu

(312)-503-3232

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 25, 2019
• Study Start: December 16, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: February 22, 2022
• Results First Posted: February 22, 2022

Record last verified: 2022-01

Locations

US (1)