Engaging Patients in Weight Loss Tools

• Sponsor: University of Florida (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04121312
• Collaborator: (none)
• Enrollment: 33
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 33.1
• Patients Per Site: 16.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Facilitation Intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Engaging Primary Care Patients in Online Weight Management Tools: A Pilot Study
• Actual Study Start Date: Oct 28, 2019
• Actual Primary Completion Date: Jul 7, 2020
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Provider retention [4-6 months (depends on patient recruitment rate)]

   Percent of enrolled providers who complete telephone interview at end of study

2. Percent of contacted providers who enroll [NA (depends on period of recruitment, approx 1 month)]

   Percent of PCPs offered the study who consent

3. 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.

4. Rate of patient recruitment [up to 16 weeks]

   Patients recruited per month during active recruitment periods

5. 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.

6. 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)

7. 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)

8. 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)

9. Weight change [baseline to 12 weeks]

   Mean weight loss (kgs) and portion of participants achieving 3% body weight loss.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. Self-reported BMI > 29 kg/m2 (to account for under-reporting)

2. Response yes to question: "Would you be interested in learning strategies to help you lose weight?"

3. Ability to read and understand English without assistance.

4. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UF Health at the University of Florida	Gainesville	Florida	United States	32610
2	UF Health - Jacksonville	Jacksonville	Florida	United States	32008

Sponsors and Collaborators

• University of Florida

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT04121312
• Other Study ID Numbers: IRB201902013; OCR26064
• First Posted: Oct 9, 2019
• Last Update Posted: Nov 5, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 5, 2021