Engaging Patients in Weight Loss Tools

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Facilitation Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PCPs: 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: Age 18-75 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: PCPs: 1. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facilitation Intervention<br>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<br>* See arm description<br>|

What is the study measuring?
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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 |