Engaging Patients in Weight Loss Tools

NCT04121312 | Completed

• 2 other identifiers: IRB201902013OCR26064
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Provider retention

  4-6 months (depends on patient recruitment rate)

• Percent of contacted providers who enroll

  NA (depends on period of recruitment, approx 1 month)

• Percent of patients who enroll

  NA (depends on period of recruitment, approx 2-4 months)

• Rate of patient recruitment

  up to 16 weeks

• Acceptability of intervention- provider

  At end of intervention (about 4-6 months after start, depending on recruitment rate)

Study Arms (1)

Facilitation Intervention

EXPERIMENTAL

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

Interventions

Facilitation Intervention BEHAVIORAL

See "arm" description

Facilitation Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• PCPs:
• \. 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

UF Health - Jacksonville

Jacksonville, Florida, 32008, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Megan McVay, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 9, 2019
• Study Start: October 28, 2019
• Primary Completion: July 7, 2020
• Study Completion: July 24, 2020
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)