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Clinical Trials/NCT04121312
NCT04121312
Completed
Not Applicable

Engaging Primary Care Patients in Online Weight Management Tools: A Pilot Study

University of Florida2 sites in 1 country33 target enrollmentOctober 28, 2019
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Florida
Enrollment
33
Locations
2
Primary Endpoint
Patient retention
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The overall aim of this study is to evaluate the acceptability and feasibility of a primary-care based approach to facilitating engagement in online behavior tracking and community support networks for weight loss ("facilitation condition") over 12 weeks among adults with obesity.

Registry
clinicaltrials.gov
Start Date
October 28, 2019
End Date
July 24, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Employed as a PCP at a clinics in the UF health care system.
  • Has practiced at current clinic for ≥1 year (self-report)
  • Is employed ≥ 0.5 FTE (self-report)
  • Has a patient panel that is majority adult (self-report)
  • Patients: EHR-based criteria:
  • Last BMI in EHR ≥30 kg/m2
  • Has an appointment scheduled ("index appointment") with an enrolled primary care PCP 7-30 days after electronic data pull.
  • Is enrolled in MyChart or has an email address in the IDR system.
  • Self-report criteria:
  • Self-reported BMI \> 29 kg/m2 (to account for under-reporting)

Exclusion Criteria

  • Planning to move out of the Gainesville or Jacksonville area in the next 12 months.
  • Patients:
  • Currently enrolled in formal weight loss program or a research study focused on changing diet, physical activity, or weight.
  • In past month, has tracked the majority of their food intake on an app, website, or paper log an average of 3 or more days per week.
  • Self-reported to be pregnant, breastfeeding, or planning to become pregnant in next 6 months.
  • Currently undergoing radiation or chemotherapy for cancer.
  • Self-reported cardiac event in past 6 months.
  • Self-reported Heart Failure (also known as chronic heart failure or CHF).
  • Planning to move out of the Gainesville or Jacksonville area (depending on which clinic they are recruited from) in the next 6 months.

Outcomes

Primary Outcomes

Patient retention

Time Frame: 12 weeks

Percent of enrolled patients completing the 12-week follow-up assessment. (NOTE: this is a feasibility pilot and is not conceptualized as having a single primary outcome)

Secondary Outcomes

  • Provider retention(4-6 months (depends on patient recruitment rate))
  • Percent of contacted providers who enroll(NA (depends on period of recruitment, approx 1 month))
  • Initial engagement in Tracking tool and social network(12 weeks)
  • Acceptability of intervention- patient: 12 study specific questions(12 weeks)
  • Sustained engagement in Tracking tool and social network(12 week assessment (queried about prior week))
  • Weight change(baseline to 12 weeks)
  • Percent of patients who enroll(NA (depends on period of recruitment, approx 2-4 months))
  • Rate of patient recruitment(up to 16 weeks)
  • Acceptability of intervention- provider(At end of intervention (about 4-6 months after start, depending on recruitment rate))

Study Sites (2)

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