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Clinical Trials/NCT04121312
NCT04121312CompletedNot Applicable

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

University of Florida2 sites in 1 country33 target enrollmentStarted: October 28, 2019Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
33
Locations
2
Primary Endpoint
Patient retention
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)
  • •Response yes to question: "Would you be interested in learning strategies to help you lose weight?"
  • •Ability to read and understand English without assistance.
  • •Has either (a) a phone or tablet with a data plan OR (b) reliable access to Wi-Fi (via computer, phone or tablet) in their home.

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.

Arms & Interventions

Facilitation Intervention

Experimental

A brief, web-based facilitation guide (called "Weight Loss Your Way Kickoff Materials") that encourages initial and sustained engagement in online tracking and social network tools for weight loss.The intervention also includes 8 emails sent over 12 weeks to further motivate use of the online tools and weight loss.

Intervention: Facilitation Intervention (Behavioral)

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

  • 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))
  • Provider retention(4-6 months (depends on patient recruitment rate))
  • Weight change(baseline to 12 weeks)
  • 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)
  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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