Supporting Decisions on Lifestyle Change

June 11, 2025 updated by: University of Florida

Increasing Initiation of Evidence-based Weight Loss Treatment

This study will test the effects of a brief, individually tailored intervention aiming to increase initiation of comprehensive behavioral weight loss treatment on weight.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

864

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 or older
  • Body Mass Index (BMI) ≥ 30 kg/m2 based on self-report body weight and height, or BMI ≥ 27-29.9 kg/m2 with a weight related comorbidity of hypertension, type 2 diabetes, pre-diabetes, dyslipidemia, or obstructive sleep apnea, gastroesophageal reflux disease, or coronary artery disease.
  • Self-report weight ≤ 375 lbs (the maximum weight that BodyTrace scales can accurately detect is 397 lbs, thus 375 lbs provides a buffer to allow detection of at least 20 lbs weight gain).
  • Has a desire to weigh less
  • Has valid email address in Electronic Health Record
  • Has an appointment scheduled with enrolled PCP about 21-28 days after electronic data pull
  • Speaks and reads English
  • Has either WiFi internet access at home or a phone or tablet with a data plan.

Exclusion criteria

  • Currently enrolled in evidence-based comprehensive weight loss treatment
  • Pregnant or planning to become pregnant in the next 6 months
  • Currently breastfeeding (or pumping breastmilk) more than 3 times per day.
  • Currently undergoing treatment for cancer
  • Had cardiovascular event in the past 60 days
  • Severe depression symptoms on PHQ-8 (total score ≥20)
  • Inpatient psychiatric treatment in the past 6 months
  • Eating disorder in past 5 years
  • Congestive heart failure resulting in recent (past 6 months) hospitalization or contributing to difficulty breathing or difficulty doing daily activities.
  • Dementia diagnosis
  • Bariatric surgery in the past year or currently undergoing evaluation for bariatric surgery
  • Currently taking doctor-prescribed medication for weight loss
  • Inability to stand on body weight scale independently
  • Impaired hearing
  • Unable to read content on websites without assistance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MyHealthPath Tool
Receive MyHealthPath Tool intervention.
Behavioral: MyHealthPath Tool
Tailored, brief online tool to help patients learn about weight treatment options
Active Comparator: MyHealthPath Guide
Receive MyHealthPath Guide intervention
Behavioral: MyHealthPath Guide
Informational material to help patients learn about weight treatment options

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion initiating treatment
Time Frame: Within 2 months of PCP appointment date
Attend at least one intervention session of comprehensive behavioral weight loss intervention. Documented by interventionist/program.
Within 2 months of PCP appointment date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment sessions attended
Time Frame: 6 months
Total number of attended intervention session of comprehensive behavioral weight loss intervention. Documented by interventionist/program.
6 months
Proportion discussing weight-related topic with PCP
Time Frame: at completion of PCP visit (occuring up to 4 weeks after enrollment)
Per patient self-report, discussed weight, diet, or physical activity with PCP at index PCP visit.
at completion of PCP visit (occuring up to 4 weeks after enrollment)
Proportion achieving 5% weight loss
Time Frame: 6 months
Proportion of participants losing 5% of their baseline weight between baseline and 6 months
6 months
Percent weight loss
Time Frame: 6 months
Percent weight loss from baseline to 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2024

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

July 30, 2028

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 11, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB202300516
  • R01DK134409 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual data will be shared with other researchers. Researchers may need to complete a data use authorization agreement.

IPD Sharing Time Frame

Data will be available within one year of study completion and remain available indefinitely.

IPD Sharing Access Criteria

Access will be granted to researchers for any scientific purpose, including verifying/replicating analyses or conducting additional analyses, or

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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