N/A
N=80
Coordinating Pragmatic Primary Care Population Management for Obesity
Obesity · Cardiovascular Risk Factor
Bottom Line
View on ClinicalTrials.gov: NCT03998046 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months — 6; 6 Participants — p=.85
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months |
6; 6 | .85 |
| SECONDARY Costs to Implement the Intervention |
423; 572 | — |
| SECONDARY Change in Hemoglobin A1C |
-.11; .09 | .20 |
| SECONDARY Change in Systolic Blood Pressure |
-3.34; .45 | .38 |
| SECONDARY Change in Total Cholesterol |
4.22; -8.59 | .02 sig |
| SECONDARY Change in Non-HDL Cholesterol |
4.14; -9.54 | .01 sig |
| SECONDARY Body Mass Change at 6 Months |
-4.19; -1.22 | .13 |
| SECONDARY Body Mass Change at 12 Months |
-3.16; -1.87 | .61 |
| SECONDARY Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months |
7; 10 | .56 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03998046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.