Engaging Patients in Weight Loss Tools

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121312
• Other study ID #: IRB201902013
• Secondary ID: OCR26064
• Status: Completed
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: July 24, 2020

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 24, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Facilitation Intervention
See "arm" description

Locations

Country	Name	City	State
United States	UF Health at the University of Florida	Gainesville	Florida
United States	UF Health - Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Provider retention	Percent of enrolled providers who complete telephone interview at end of study	4-6 months (depends on patient recruitment rate)
Secondary	Percent of contacted providers who enroll	Percent of PCPs offered the study who consent	NA (depends on period of recruitment, approx 1 month)
Secondary	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)
Secondary	Rate of patient recruitment	Patients recruited per month during active recruitment periods	up to 16 weeks
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	Weight change	Mean weight loss (kgs) and portion of participants achieving 3% body weight loss.	baseline to 12 weeks