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Enrolling by invitation NCT06206954

Supporting Decisions on Lifestyle Change

No phase Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MyHealthPath Tool, MyHealthPath Guide.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Increasing Initiation of Evidence-based Weight Loss Treatment

Overview

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

Interventions

  • Behavioral MyHealthPath Tool
    Tailored, brief online tool to help patients learn about weight treatment options
  • Behavioral MyHealthPath Guide
    Informational material to help patients learn about weight treatment options

Primary outcome measures

  • Proportion initiating treatment [Time frame: Within 2 months of PCP appointment date]
Secondary outcome measures (4)
  • Number of treatment sessions attended [Time frame: 6 months]
  • Proportion discussing weight-related topic with PCP [Time frame: at completion of PCP visit (occuring up to 4 weeks after enrollment)]
  • Proportion achieving 5% weight loss [Time frame: 6 months]
  • Percent weight loss [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Florida — Gainesville

Publications

  • McVay MA, Moore WS, Deceus D, Townsend SB, Rosenberg EI, Muenyi S, Lou X, Webb FJ, Diaz LD, Shankar MN, Ruiz J, Voils CI, Ross KM. A brief online tool to increase behavioral weight loss treatment initiation: Protocol for a cluster randomized trial. Contemp Clin Trials. 2025 Jul;154:107948. doi: 10.1016/j.cct.2025.107948. Epub 2025 May 15. PMID 40381908

Identifiers

NCT: NCT06206954 · IRB202300516 · R01DK134409

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗