Clinical trial NCT03998046: Coordinating Pragmatic Primary Care Population Management for Obesity
Official title: Coordinating Pragmatic Primary Care Population Management for Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Risk Factor
Keywords: overweight
obesity
prediabetes
type 2 diabetes
hypertension
dyslipidemia
cardiovascular risk factor
adult
primary care
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-06-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months
timeFrame: Baseline - 6 Months
Secondary outcomes:
measure: Costs to Implement the Intervention
timeFrame: Baseline - 12 Months
measure: Change in Hemoglobin A1C
timeFrame: Baseline - 12 Months
measure: Change in Systolic Blood Pressure
timeFrame: Baseline - 12 Months
measure: Change in Total Cholesterol
timeFrame: Baseline - 12 Months
measure: Change in Non-HDL Cholesterol
timeFrame: Baseline - 12 Months
measure: Body Mass Change at 6 Months
timeFrame: Baseline - 6 Months
measure: Body Mass Change at 12 Months
timeFrame: Baseline - 12 Months
measure: Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months
timeFrame: Baseline - 12 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
References: