Status:
ENROLLING_BY_INVITATION
Supporting Decisions on Lifestyle Change
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will test the effects of a brief, individually tailored intervention aiming to increase initiation of comprehensive behavioral weight loss treatment on weight.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2028
Estimated Enrollment :
864 Patients enrolled
Trial Details
Trial ID
NCT06206954
Start Date
January 24 2024
End Date
July 30 2028
Last Update
June 15 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32611