Supporting Decisions on Lifestyle Change

University of Florida

Status: Invitation-only

Conditions: Obesity

Treatments: Behavioral: MyHealthPath Guide; Behavioral: MyHealthPath Tool

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06206954

R01DK134409 (U.S. NIH Grant/Contract)

IRB202300516

Details and patient eligibility

About

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

Enrollment: 864 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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864 participants in 2 patient groups

MyHealthPath Tool

Experimental group

Description:

Receive MyHealthPath Tool intervention.

Treatment:

Behavioral: MyHealthPath Tool

MyHealthPath Guide

Active Comparator group

Description:

Receive MyHealthPath Guide intervention

Treatment:

Behavioral: MyHealthPath Guide