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Completed

NCT Number: NCT03998046

Coordinating Pragmatic Primary Care Population Management for Obesity

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Cardiovascular Risk Factor Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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

Primary outcomes

  1. Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months

    Time frame: 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 outcomes

  1. Costs to Implement the Intervention

    Time frame: Baseline - 12 Months

    Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components

  2. Change in Hemoglobin A1C

    Time frame: Baseline - 12 Months

    Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months

  3. Change in Systolic Blood Pressure

    Time frame: Baseline - 12 Months

    Mean change in systolic blood pressure (mmHg) from baseline to 12 months

  4. Change in Total Cholesterol

    Time frame: Baseline - 12 Months

    Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months

  5. Change in Non-HDL Cholesterol

    Time frame: Baseline - 12 Months

    Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months

  6. Body Mass Change at 6 Months

    Time frame: Baseline - 6 Months

    Mean Change in Body Mass (kg) from Baseline to 6 Months

  7. Body Mass Change at 12 Months

    Time frame: Baseline - 12 Months

    Mean Change in Body Mass (kg) from Baseline to 12 Months

  8. Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months

    Time frame: 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))

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: C3PO

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jun 25, 2019
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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