Engaging Patients in Weight Loss Tools

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

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Facilitation Intervention

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health at the University of Florida
    • Jacksonville, Florida, United States, 32008
      • UF Health - Jacksonville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• PCPs:

  1. Employed as a PCP at a clinics in the UF health care system.
  2. Has practiced at current clinic for ≥1 year (self-report)
  3. Is employed ≥ 0.5 FTE (self-report)
  4. Has a patient panel that is majority adult (self-report)

• Patients: EHR-based criteria:

  1. Age 18-75
  2. Last BMI in EHR ≥30 kg/m2
  3. Has an appointment scheduled ("index appointment") with an enrolled primary care PCP 7-30 days after electronic data pull.

  4. Is enrolled in MyChart or has an email address in the IDR system.

     Self-report criteria:

  5. Self-reported BMI > 29 kg/m2 (to account for under-reporting)
  6. Response yes to question: "Would you be interested in learning strategies to help you lose weight?"
  7. Ability to read and understand English without assistance.
  8. 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:

• PCPs:

  1. Planning to move out of the Gainesville or Jacksonville area in the next 12 months.

• Patients:

  1. Currently enrolled in formal weight loss program or a research study focused on changing diet, physical activity, or weight.
  2. 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.
  3. Self-reported to be pregnant, breastfeeding, or planning to become pregnant in next 6 months.
  4. Currently undergoing radiation or chemotherapy for cancer.
  5. Self-reported cardiac event in past 6 months.
  6. Self-reported Heart Failure (also known as chronic heart failure or CHF).
  7. Planning to move out of the Gainesville or Jacksonville area (depending on which clinic they are recruited from) in the next 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facilitation Intervention; 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.	Behavioral: Facilitation Intervention; See "arm" description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient retention	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)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider retention	Percent of enrolled providers who complete telephone interview at end of study	4-6 months (depends on patient recruitment rate)
Percent of contacted providers who enroll	Percent of PCPs offered the study who consent	NA (depends on period of recruitment, approx 1 month)
Percent of patients who enroll	Percent of patients contacted who are eligible and agree to participate.	NA (depends on period of recruitment, approx 2-4 months)
Rate of patient recruitment	Patients recruited per month during active recruitment periods	up to 16 weeks
Acceptability of intervention- provider	Response to 5 study specific questions asking about alignment with priorities, fit in workflow, feasibility, perception of patient benefit, and time. Also, response to open ended question about acceptability.	At end of intervention (about 4-6 months after start, depending on recruitment rate)
Acceptability of intervention- patient: 12 study specific questions	Response to 12 study specific questions asking about experience with "Weight Loss Your Way" kickoff materials; open ended response to questions about acceptability of intervention during qualitative interviews (of portion of enrollees)	12 weeks
Initial engagement in Tracking tool and social network	Portion of patients who initially engage with tracking tool (i.e., log at least one food item or physical activity) and with social network (i.e., who report reading message board or posting at least once) (tracking and social network examined separately)	12 weeks
Sustained engagement in Tracking tool and social network	Portion of patients who have used the tracking tool and social network at least once in past week at 12 week assessment (tracking and social network examined separately)	12 week assessment (queried about prior week)
Weight change	Mean weight loss (kgs) and portion of participants achieving 3% body weight loss.	baseline to 12 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Megan McVay, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Actual): July 7, 2020
• Study Completion (Actual): July 24, 2020

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB201902013; OCR26064 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No