ObesityC3PONCT03998046
Coordinating Pragmatic Primary Care Population Management for Obesity
A study testing Outreach Support for Weight Loss Goal Setting and Self-Weighing, Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions and Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support in people with Obesity and Cardiovascular Risk Factor, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Cardiovascular Risk Factor
- What is being tested?
- Outreach Support for Weight Loss Goal Setting and Self-Weighing, Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions and Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity, Cardiovascular Risk Factor
- Being tested
- Outreach Support for Weight Loss Goal Setting and Self-Weighing, Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions, Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support
- Keywords
- overweight, obesity, prediabetes, type 2 diabetes, hypertension, dyslipidemia, cardiovascular risk factor, adult, primary care
- Medical subject headings
- Obesity, Overweight, Prediabetic State, Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outreach Support for Weight Loss Goal Setting and Self-WeighingBehavioural
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 InterventionsBehavioural
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 SupportBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: Baseline - 6 Months
Secondary outcomes (8)
Costs to Implement the Intervention
Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components
Measured: Baseline - 12 Months
Change in Hemoglobin A1C
Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
Measured: Baseline - 12 Months
Change in Systolic Blood Pressure
Mean change in systolic blood pressure (mmHg) from baseline to 12 months
Measured: Baseline - 12 Months
Change in Total Cholesterol
Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months
Measured: Baseline - 12 Months
Change in Non-HDL Cholesterol
Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months
Measured: Baseline - 12 Months
Body Mass Change at 6 Months
Mean Change in Body Mass (kg) from Baseline to 6 Months
Measured: Baseline - 6 Months
Body Mass Change at 12 Months
Mean Change in Body Mass (kg) from Baseline to 12 Months
Measured: Baseline - 12 Months
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))
Measured: Baseline - 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start16 Dec 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Ackermann, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998046
- Sponsor's protocol ID
- STU00207153
- Other IDs
- R34DK114773
- Acronym
- C3PO
- Status last verified
- Jan 2022
- First submitted
- 21 Jun 2019
- Last updated
- 22 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ackermann RT, Cameron KA, Liss DT, Dolan N, Aikman C, Carson AR, Harris SA, Doyle K, Cooper AJ, Hitsman B. Hybrid Health IT and Telehealth-Delivered Behavioral Weight Loss Services for Primary Care Patients With Cardiovascular Risk Factors: Intervention Component Design and Pragmatic Randomized Feasibility Trial. JMIR Mhealth Uhealth. 2025 Oct 22;13:e58722. doi: 10.2196/58722.
PubMed 41126509
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinating Pragmatic Primary Care Population Management for Obesity
- ClinicalTrials.gov ID
- NCT03998046
- Acronym / sponsor ID
- C3PO / STU00207153
- Conditions
- Obesity, Cardiovascular Risk Factor
- Keywords
- overweight, obesity, prediabetes, type 2 diabetes, hypertension, dyslipidemia, cardiovascular risk factor, adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Posted 22 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Basic Resources and Services | Active comparator | Behavioral: Outreach Support for Weight Loss Goal Setting and Self-Weighing, Behavioral: Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle InterventionsPatients 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 |
| Coordinated Primary Care Population Management (C3PO) | Experimental | 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 SupportPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outreach Support for Weight Loss Goal Setting and Self-WeighingPatients 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. | Behavioural | Basic Resources and Services, Coordinated Primary Care Population Management (C3PO) |
| Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle InterventionsPatients 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. | Behavioural | Basic Resources and Services, Coordinated Primary Care Population Management (C3PO) |
| Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach SupportData 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 | Behavioural | Coordinated Primary Care Population Management (C3PO) |
Primary outcome
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))
8 secondary outcomes
Costs to Implement the Intervention
Time frame: Baseline - 12 Months
Change in Hemoglobin A1C
Time frame: Baseline - 12 Months
Change in Systolic Blood Pressure
Time frame: Baseline - 12 Months
Change in Total Cholesterol
Time frame: Baseline - 12 Months
Change in Non-HDL Cholesterol
Time frame: Baseline - 12 Months
Body Mass Change at 6 Months
Time frame: Baseline - 6 Months
Body Mass Change at 12 Months
Time frame: Baseline - 12 Months
Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months
Time frame: Baseline - 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41126509Ackermann RT, Cameron KA, Liss DT, Dolan N, Aikman C, Carson AR, Harris SA, Doyle K, Cooper AJ, Hitsman B. Hybrid Health IT and Telehealth-Delivered Behavioral Weight Loss Services for Primary Care Patients With Cardiovascular Risk Factors: Intervention Component Design and Pragmatic Randomized Feasibility Trial. JMIR Mhealth Uhealth. 2025 Oct 22;13:e58722. doi: 10.2196/58722.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outreach Support for Weight Loss Goal Setting and Self-Weighing, Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions and Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support in people with Obesity and Cardiovascular Risk Factor, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months (time frame: Baseline - 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03998046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.