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OpenTrials
Enrolling by Invitation

NCT Number: NCT06206954

Supporting Decisions on Lifestyle Change

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

Enrolling by Invitation

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MyHealthPath Tool

Behavioral

Tailored, brief online tool to help patients learn about weight treatment options

MyHealthPath Guide

Behavioral

Informational material to help patients learn about weight treatment options

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Proportion achieving 5% weight loss

    Time frame: 6 months

    Proportion of participants losing 5% of their baseline weight between baseline and 6 months

  4. Percent weight loss

    Time frame: 6 months

    Percent weight loss from baseline to 6 months

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

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

Registry information

Official study title

Increasing Initiation of Evidence-based Weight Loss Treatment

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 16, 2024
Registry last updated
Jun 15, 2025

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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