Clinical trial NCT04121312: Engaging Patients in Weight Loss Tools
Official title: Engaging Primary Care Patients in Online Weight Management Tools: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient retention
timeFrame: 12 weeks
Secondary outcomes:
measure: Provider retention
timeFrame: 4-6 months (depends on patient recruitment rate)
measure: Percent of contacted providers who enroll
timeFrame: NA (depends on period of recruitment, approx 1 month)
measure: Percent of patients who enroll
timeFrame: NA (depends on period of recruitment, approx 2-4 months)
measure: Rate of patient recruitment
timeFrame: up to 16 weeks
measure: Acceptability of intervention- provider
timeFrame: At end of intervention (about 4-6 months after start, depending on recruitment rate)
measure: Acceptability of intervention- patient: 12 study specific questions
timeFrame: 12 weeks
measure: Initial engagement in Tracking tool and social network
timeFrame: 12 weeks
measure: Sustained engagement in Tracking tool and social network
timeFrame: 12 week assessment (queried about prior week)
measure: Weight change
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
city: Jacksonville
country: United States
facility: UF Health - Jacksonville
state: Florida
Study officials:
affiliation: University of Florida
name: Megan McVay, PhD
role: PRINCIPAL_INVESTIGATOR
References: