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OpenTrials
Completed

NCT Number: NCT04121312

Engaging Patients in Weight Loss Tools

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health at the University of Florida, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

Facilitation Intervention

Behavioral

See "arm" description

Primary outcomes

  1. Patient retention

    Time frame: 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 outcomes

  1. Provider retention

    Time frame: 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

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

    Percent of PCPs offered the study who consent

  3. Percent of patients who enroll

    Time frame: 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

    Time frame: up to 16 weeks

    Patients recruited per month during active recruitment periods

  5. Acceptability of intervention- provider

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: baseline to 12 weeks

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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2019
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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