Engaging Patients in Weight Loss Tools

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Facilitation Intervention

• Registration Number: NCT04121312
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-09
• Study Start: 2019-10-28
• Primary Completion: 2020-07-07
• Study Completion: 2020-07-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Facilitation Intervention	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.

Primary Outcome Measures

Name	Time	Method
Patient retention	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 Outcome Measures

Name	Time	Method
Provider retention	4-6 months (depends on patient recruitment rate)	Percent of enrolled providers who complete telephone interview at end of study
Percent of contacted providers who enroll	NA (depends on period of recruitment, approx 1 month)	Percent of PCPs offered the study who consent
Sustained engagement in Tracking tool and social network	12 week assessment (queried about prior week)	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)
Initial engagement in Tracking tool and social network	12 weeks	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)
Weight change	baseline to 12 weeks	Mean weight loss (kgs) and portion of participants achieving 3% body weight loss.
Acceptability of intervention- patient: 12 study specific questions	12 weeks	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)
Percent of patients who enroll	NA (depends on period of recruitment, approx 2-4 months)	Percent of patients contacted who are eligible and agree to participate.
Rate of patient recruitment	up to 16 weeks	Patients recruited per month during active recruitment periods
Acceptability of intervention- provider	At end of intervention (about 4-6 months after start, depending on recruitment rate)	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.

Trial Locations

Locations (2)

UF Health - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

UF Health at the University of Florida; 🇺🇸 Gainesville, Florida, United States